Trial Outcomes & Findings for CoQ10 and D-ribose in Patients With Diastolic Heart Failure (NCT NCT03133793)
NCT ID: NCT03133793
Last Updated: 2022-03-18
Results Overview
Patients' perceptions of their symptoms were measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a self-administered questionnaire that measures patients' perceptions of five domains of their health status relevant to HFpEF. The KCCQ is a 24 item questionnaire. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
216 participants
Primary outcome timeframe
Change from Baseline to Week 12
Results posted on
2022-03-18
Participant Flow
Enrollment started for this clinical trial February 5, 2018 and recruitment occurred at The University of Kansas Hospital in the cardiology and heart failure clinics.
Trial included a 7 day run-in period where the participant was asked to take placebo capsules and powder. They had to consume 80% of both placebo items to be randomized into the study. There were many subjects who signed the consent form and started on the run-in period but never returned for data collection (n=63).
Participant milestones
| Measure |
Placebo Only
Participants in this group received placebo pills and placebo powder.
Placebo pills: Participants took matched placebo pills that were 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants mixed 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
CoQ10 (Ubiquinol) Only
Participants in this group received CoQ10 (ubiquinol) capsules and placebo powder
CoQ10 (Ubiquinol): Participants took 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants mixed 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
D-ribose Only
Participants in this group received placebo pills and D-ribose oral powder.
D-Ribose Oral Powder: Participants mixed 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Placebo pills: Participants took matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
|
CoQ10 (Ubiquinol) + D-ribose
Participants in this group received CoQ10 (ubiquinol) capsules and D-ribose oral powder.
CoQ10 (Ubiquinol): Participants took 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
D-Ribose Oral Powder: Participants mixed 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
37
|
38
|
|
Overall Study
COMPLETED
|
38
|
35
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
4
|
5
|
Reasons for withdrawal
| Measure |
Placebo Only
Participants in this group received placebo pills and placebo powder.
Placebo pills: Participants took matched placebo pills that were 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants mixed 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
CoQ10 (Ubiquinol) Only
Participants in this group received CoQ10 (ubiquinol) capsules and placebo powder
CoQ10 (Ubiquinol): Participants took 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants mixed 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
D-ribose Only
Participants in this group received placebo pills and D-ribose oral powder.
D-Ribose Oral Powder: Participants mixed 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Placebo pills: Participants took matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
|
CoQ10 (Ubiquinol) + D-ribose
Participants in this group received CoQ10 (ubiquinol) capsules and D-ribose oral powder.
CoQ10 (Ubiquinol): Participants took 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
D-Ribose Oral Powder: Participants mixed 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
Baseline Characteristics
With some patients that were obese, we could obtain an ejection fraction but not an septal E/e' value.
Baseline characteristics by cohort
| Measure |
Placebo Only
n=39 Participants
Participants in this group will receive placebo pills and placebo powder.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
CoQ10 Only
n=39 Participants
Participants in this group will receive CoQ10 pills and placebo powder
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
D-ribose Only
n=37 Participants
Participants in this group will receive placebo pills and D-ribose oral powder.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
|
CoQ10 + D-ribose
n=38 Participants
Participants in this group will receive CoQ10 pills and D-ribose oral powder.
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=153 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=39 Participants
|
12 Participants
n=39 Participants
|
14 Participants
n=37 Participants
|
12 Participants
n=38 Participants
|
49 Participants
n=153 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=39 Participants
|
27 Participants
n=39 Participants
|
23 Participants
n=37 Participants
|
26 Participants
n=38 Participants
|
104 Participants
n=153 Participants
|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 9.3 • n=39 Participants
|
67.0 years
STANDARD_DEVIATION 10.6 • n=39 Participants
|
72.0 years
STANDARD_DEVIATION 10.6 • n=37 Participants
|
69.5 years
STANDARD_DEVIATION 9.4 • n=38 Participants
|
69 years
STANDARD_DEVIATION 10.1 • n=153 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=39 Participants
|
21 Participants
n=39 Participants
|
22 Participants
n=37 Participants
|
20 Participants
n=38 Participants
|
86 Participants
n=153 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=39 Participants
|
18 Participants
n=39 Participants
|
15 Participants
n=37 Participants
|
18 Participants
n=38 Participants
|
67 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Hispanic or Latino
|
1 Participants
n=39 Participants
|
3 Participants
n=39 Participants
|
1 Participants
n=37 Participants
|
4 Participants
n=38 Participants
|
9 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Non-Hispanic
|
37 Participants
n=39 Participants
|
36 Participants
n=39 Participants
|
36 Participants
n=37 Participants
|
34 Participants
n=38 Participants
|
143 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Ethnicity : Unknown
|
1 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=38 Participants
|
1 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Race : African American
|
7 Participants
n=39 Participants
|
7 Participants
n=39 Participants
|
6 Participants
n=37 Participants
|
6 Participants
n=38 Participants
|
26 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Race: American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=37 Participants
|
2 Participants
n=38 Participants
|
3 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Race: Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=38 Participants
|
1 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=38 Participants
|
1 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=39 Participants
|
2 Participants
n=39 Participants
|
1 Participants
n=37 Participants
|
1 Participants
n=38 Participants
|
4 Participants
n=153 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=39 Participants
|
30 Participants
n=39 Participants
|
29 Participants
n=37 Participants
|
27 Participants
n=38 Participants
|
118 Participants
n=153 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=39 Participants
|
39 participants
n=39 Participants
|
37 participants
n=37 Participants
|
38 participants
n=38 Participants
|
153 participants
n=153 Participants
|
|
Kansas City Cardiomyopathy Questionnaire
|
48.52 units on a scale
STANDARD_DEVIATION 24.23 • n=39 Participants
|
51.88 units on a scale
STANDARD_DEVIATION 23.17 • n=39 Participants
|
44.05 units on a scale
STANDARD_DEVIATION 19.11 • n=37 Participants
|
45.63 units on a scale
STANDARD_DEVIATION 21.6 • n=38 Participants
|
47.52 units on a scale
STANDARD_DEVIATION 22.03 • n=153 Participants
|
|
Vigor Scale
|
13.79 units on a scale
STANDARD_DEVIATION 5.7 • n=39 Participants
|
13 units on a scale
STANDARD_DEVIATION 5.49 • n=39 Participants
|
13.94 units on a scale
STANDARD_DEVIATION 7.11 • n=37 Participants
|
12.21 units on a scale
STANDARD_DEVIATION 5.57 • n=38 Participants
|
13.24 units on a scale
STANDARD_DEVIATION 5.97 • n=153 Participants
|
|
Ejection Fraction (EF)
|
51.04 percentage of ejection fraction
STANDARD_DEVIATION 7.43 • n=37 Participants • With some patients that were obese, we could obtain an ejection fraction but not an septal E/e' value.
|
51.89 percentage of ejection fraction
STANDARD_DEVIATION 5.68 • n=33 Participants • With some patients that were obese, we could obtain an ejection fraction but not an septal E/e' value.
|
50.79 percentage of ejection fraction
STANDARD_DEVIATION 4.38 • n=31 Participants • With some patients that were obese, we could obtain an ejection fraction but not an septal E/e' value.
|
51.28 percentage of ejection fraction
STANDARD_DEVIATION 4.76 • n=32 Participants • With some patients that were obese, we could obtain an ejection fraction but not an septal E/e' value.
|
51.25 percentage of ejection fraction
STANDARD_DEVIATION 5.56 • n=133 Participants • With some patients that were obese, we could obtain an ejection fraction but not an septal E/e' value.
|
|
6-minute walking test (6MWT)
|
247.87 meters
STANDARD_DEVIATION 150.96 • n=38 Participants • Some participants were unable to walk that day. They either did not feel well or forgot to wear proper shoes so they did not want to walk.
|
322.69 meters
STANDARD_DEVIATION 124.18 • n=34 Participants • Some participants were unable to walk that day. They either did not feel well or forgot to wear proper shoes so they did not want to walk.
|
265.58 meters
STANDARD_DEVIATION 135.96 • n=33 Participants • Some participants were unable to walk that day. They either did not feel well or forgot to wear proper shoes so they did not want to walk.
|
237.85 meters
STANDARD_DEVIATION 131.05 • n=33 Participants • Some participants were unable to walk that day. They either did not feel well or forgot to wear proper shoes so they did not want to walk.
|
268.49 meters
STANDARD_DEVIATION 135.54 • n=138 Participants • Some participants were unable to walk that day. They either did not feel well or forgot to wear proper shoes so they did not want to walk.
|
|
B-type natriuretic peptide (BNP) level
|
232 pg/mL
STANDARD_DEVIATION 388.28 • n=38 Participants • Some of the participants we were unable to obtain a blood sample or they refused.
|
182.51 pg/mL
STANDARD_DEVIATION 211.23 • n=35 Participants • Some of the participants we were unable to obtain a blood sample or they refused.
|
152.48 pg/mL
STANDARD_DEVIATION 141.52 • n=33 Participants • Some of the participants we were unable to obtain a blood sample or they refused.
|
157.09 pg/mL
STANDARD_DEVIATION 155.27 • n=32 Participants • Some of the participants we were unable to obtain a blood sample or they refused.
|
181.02 pg/mL
STANDARD_DEVIATION 224.08 • n=138 Participants • Some of the participants we were unable to obtain a blood sample or they refused.
|
|
lactate
|
2.45 mmol/L
STANDARD_DEVIATION 1.13 • n=38 Participants • During the participant visit we either had instrument error or the patient did not want us to stick them again.
|
2.58 mmol/L
STANDARD_DEVIATION 1.04 • n=35 Participants • During the participant visit we either had instrument error or the patient did not want us to stick them again.
|
2.34 mmol/L
STANDARD_DEVIATION 1.12 • n=33 Participants • During the participant visit we either had instrument error or the patient did not want us to stick them again.
|
2.72 mmol/L
STANDARD_DEVIATION 1.59 • n=31 Participants • During the participant visit we either had instrument error or the patient did not want us to stick them again.
|
2.52 mmol/L
STANDARD_DEVIATION 1.22 • n=137 Participants • During the participant visit we either had instrument error or the patient did not want us to stick them again.
|
|
Septal E/e'
|
9.41 ratio
STANDARD_DEVIATION 5.54 • n=33 Participants • If the patient was obese, it was difficult to obtain a measurement using a 2-D doppler system.
|
9.8 ratio
STANDARD_DEVIATION 4.27 • n=29 Participants • If the patient was obese, it was difficult to obtain a measurement using a 2-D doppler system.
|
11.2 ratio
STANDARD_DEVIATION 5.97 • n=28 Participants • If the patient was obese, it was difficult to obtain a measurement using a 2-D doppler system.
|
9.35 ratio
STANDARD_DEVIATION 4.24 • n=27 Participants • If the patient was obese, it was difficult to obtain a measurement using a 2-D doppler system.
|
9.94 ratio
STANDARD_DEVIATION 5.05 • n=117 Participants • If the patient was obese, it was difficult to obtain a measurement using a 2-D doppler system.
|
|
Adenosine Phosphate (ATP)
|
3332.87 Relative Light Units (RLU)
STANDARD_DEVIATION 844.33 • n=38 Participants • We were unable to obtain blood samples from some subjects due to difficulty obtaining the sample or the patient refusing the test.
|
3222.63 Relative Light Units (RLU)
STANDARD_DEVIATION 1040.44 • n=35 Participants • We were unable to obtain blood samples from some subjects due to difficulty obtaining the sample or the patient refusing the test.
|
3312.18 Relative Light Units (RLU)
STANDARD_DEVIATION 915.98 • n=33 Participants • We were unable to obtain blood samples from some subjects due to difficulty obtaining the sample or the patient refusing the test.
|
3383.24 Relative Light Units (RLU)
STANDARD_DEVIATION 954.03 • n=33 Participants • We were unable to obtain blood samples from some subjects due to difficulty obtaining the sample or the patient refusing the test.
|
3312.73 Relative Light Units (RLU)
STANDARD_DEVIATION 938.695 • n=139 Participants • We were unable to obtain blood samples from some subjects due to difficulty obtaining the sample or the patient refusing the test.
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 12Population: A few of the subjects refused to complete the questionnaire or drop out of the study due to COVID-19.
Patients' perceptions of their symptoms were measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a self-administered questionnaire that measures patients' perceptions of five domains of their health status relevant to HFpEF. The KCCQ is a 24 item questionnaire. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Outcome measures
| Measure |
Placebo Only
n=37 Participants
Participants in this group will receive placebo pills and placebo powder.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
CoQ10 Only
n=35 Participants
Participants in this group will receive CoQ10 pills and placebo powder
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
D-ribose Only
n=33 Participants
Participants in this group will receive placebo pills and D-ribose oral powder.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
|
CoQ10 + D-ribose
n=33 Participants
Participants in this group will receive CoQ10 pills and D-ribose oral powder.
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
|---|---|---|---|---|
|
Change in Health Status of Patients With HFpEF
|
4.15 Scores on a scale
Standard Deviation 24.04
|
26.56 Scores on a scale
Standard Deviation 18.61
|
29.97 Scores on a scale
Standard Deviation 21.95
|
33 Scores on a scale
Standard Deviation 21.45
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: A few of the subjects refused to complete the questionnaire or drop out of the study due to COVID-19.
Change were measured using the the Vigor subscale from the Profile of Mood States (POMS) questionnaire. Patients rated themselves on eight adjectives (lively, active, energetic, cheerful, alert, full of pep, carefree, and vigorous) on a five-point scale (0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, and 4 = extremely). Scores for the subscale range from 0-32, in which higher scores of 32 reflected more vigor and a score of 0 reflected no vigor.
Outcome measures
| Measure |
Placebo Only
n=37 Participants
Participants in this group will receive placebo pills and placebo powder.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
CoQ10 Only
n=35 Participants
Participants in this group will receive CoQ10 pills and placebo powder
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
D-ribose Only
n=33 Participants
Participants in this group will receive placebo pills and D-ribose oral powder.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
|
CoQ10 + D-ribose
n=33 Participants
Participants in this group will receive CoQ10 pills and D-ribose oral powder.
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
|---|---|---|---|---|
|
Change in Vigor
|
-0.54 Scores on a scale
Standard Deviation 7.32
|
7.11 Scores on a scale
Standard Deviation 5.1
|
7.3 Scores on a scale
Standard Deviation 6.79
|
7.61 Scores on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: Some of the patients were morbidly obese and we were unable to obtain accurate ejection fraction measurements.
Change was measured using the the ejection fraction using echocardiographic imaging. Ejection fraction (EF) is the percentage of blood volume ejected in each cardiac cycle and is a representation of left ventricular systolic performance.
Outcome measures
| Measure |
Placebo Only
n=36 Participants
Participants in this group will receive placebo pills and placebo powder.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
CoQ10 Only
n=33 Participants
Participants in this group will receive CoQ10 pills and placebo powder
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
D-ribose Only
n=30 Participants
Participants in this group will receive placebo pills and D-ribose oral powder.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
|
CoQ10 + D-ribose
n=30 Participants
Participants in this group will receive CoQ10 pills and D-ribose oral powder.
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
|---|---|---|---|---|
|
Change in Ejection Fraction (EF)
|
-2.39 percentage of ejection fraction
Standard Deviation 6.96
|
4.69 percentage of ejection fraction
Standard Deviation 7.72
|
5.64 percentage of ejection fraction
Standard Deviation 6.67
|
5.07 percentage of ejection fraction
Standard Deviation 7.14
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: Some of the participants were morbidly obese and we were unable to obtain accurate images.
Change was measured using the the Septal E/e' using advanced echocardiographic imaging. Septal E/e' is the early diastolic mitral annulus velocity (e') estimated by tissue Doppler using an echocardiogram and the ratio of the transmitral early peak velocity (E) by pulsed wave Doppler over e' (E/e'). These are the two key parameters for grading a diastolic dysfunction as they represent a reliable noninvasive surrogate for left ventricular diastolic pressures.
Outcome measures
| Measure |
Placebo Only
n=36 Participants
Participants in this group will receive placebo pills and placebo powder.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
CoQ10 Only
n=33 Participants
Participants in this group will receive CoQ10 pills and placebo powder
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
D-ribose Only
n=30 Participants
Participants in this group will receive placebo pills and D-ribose oral powder.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
|
CoQ10 + D-ribose
n=30 Participants
Participants in this group will receive CoQ10 pills and D-ribose oral powder.
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
|---|---|---|---|---|
|
Change in Septal E/e'
|
1.39 ratio
Standard Deviation 7.74
|
-1.27 ratio
Standard Deviation 4.17
|
-0.65 ratio
Standard Deviation 6.48
|
-0.47 ratio
Standard Deviation 4.40
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: A few of the subjects were refused to walk due to an injury or drop out of the study due to COVID-19.
Change was measured using the 6-minute walking test. The 6-minute walking test (6MWT) is a simple test. Test measures the total distance in meters a person can walk in 6 minutes.
Outcome measures
| Measure |
Placebo Only
n=38 Participants
Participants in this group will receive placebo pills and placebo powder.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
CoQ10 Only
n=34 Participants
Participants in this group will receive CoQ10 pills and placebo powder
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
D-ribose Only
n=33 Participants
Participants in this group will receive placebo pills and D-ribose oral powder.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
|
CoQ10 + D-ribose
n=33 Participants
Participants in this group will receive CoQ10 pills and D-ribose oral powder.
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
|---|---|---|---|---|
|
Change in 6 Minute Walk Test (6MWT)
|
19.62 meters
Standard Deviation 76.27
|
21.21 meters
Standard Deviation 36.73
|
29.42 meters
Standard Deviation 52.92
|
36.21 meters
Standard Deviation 42.28
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: We were unable to obtain blood on a few subjects or they drop out of the study due to COVID-19.
Change was measured for brain natriuretic peptide. Brain natriuretic peptide (BNP) levels are objective measures of cardiac function. BNP testing is a useful tool in predicting prognoses in patients with heart failure
Outcome measures
| Measure |
Placebo Only
n=38 Participants
Participants in this group will receive placebo pills and placebo powder.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
CoQ10 Only
n=33 Participants
Participants in this group will receive CoQ10 pills and placebo powder
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
D-ribose Only
n=31 Participants
Participants in this group will receive placebo pills and D-ribose oral powder.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
|
CoQ10 + D-ribose
n=29 Participants
Participants in this group will receive CoQ10 pills and D-ribose oral powder.
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
|---|---|---|---|---|
|
Change in Venous Blood B-type Natriuretic Peptide (BNP) Levels
|
-18.43 pg/mL
Standard Deviation 80.37
|
-29.56 pg/mL
Standard Deviation 67.43
|
-42.94 pg/mL
Standard Deviation 72.47
|
29.08 pg/mL
Standard Deviation 68.08
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: The number analyzed in one or more rows differs because we had either an instrument error or we were unable to obtain an adequate blood sample.
Change was measured for lactate. Lactate is produced by anaerobic metabolism and may reflect inadequate tissue perfusion in conditions such heart failure with preserved ejection fraction.
Outcome measures
| Measure |
Placebo Only
n=38 Participants
Participants in this group will receive placebo pills and placebo powder.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
CoQ10 Only
n=34 Participants
Participants in this group will receive CoQ10 pills and placebo powder
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
D-ribose Only
n=32 Participants
Participants in this group will receive placebo pills and D-ribose oral powder.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
|
CoQ10 + D-ribose
n=31 Participants
Participants in this group will receive CoQ10 pills and D-ribose oral powder.
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
|---|---|---|---|---|
|
Change in Lactate
|
0.33 mmol/L
Standard Deviation 1.26
|
0 mmol/L
Standard Deviation 0.79
|
-0.35 mmol/L
Standard Deviation 0.7
|
-0.24 mmol/L
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Population: The number analyzed in one or more rows differs because we had either an instrument error or we were unable to obtain an adequate blood sample.
All cellular processes require ATP as a primary energy source. The heart requires ATP for the function of membrane transport systems (e.g., Na+/K+-ATPase) as well as for sarcomere contraction and relaxation.
Outcome measures
| Measure |
Placebo Only
n=38 Participants
Participants in this group will receive placebo pills and placebo powder.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
CoQ10 Only
n=34 Participants
Participants in this group will receive CoQ10 pills and placebo powder
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
D-ribose Only
n=32 Participants
Participants in this group will receive placebo pills and D-ribose oral powder.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
|
CoQ10 + D-ribose
n=31 Participants
Participants in this group will receive CoQ10 pills and D-ribose oral powder.
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
|---|---|---|---|---|
|
Change in Adenosine Triphosphate (ATP)
|
-189.08 relative light units (RLU)
Standard Deviation 828.43
|
1133.5 relative light units (RLU)
Standard Deviation 997.89
|
907.44 relative light units (RLU)
Standard Deviation 1006.78
|
686.19 relative light units (RLU)
Standard Deviation 1018.41
|
Adverse Events
Placebo Only
Serious events: 8 serious events
Other events: 2 other events
Deaths: 0 deaths
CoQ10 Only
Serious events: 10 serious events
Other events: 1 other events
Deaths: 0 deaths
D-ribose Only
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
CoQ10 + D-ribose
Serious events: 7 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo Only
n=38 participants at risk
Participants in this group will receive placebo pills and placebo powder.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
CoQ10 Only
n=35 participants at risk
Participants in this group will receive CoQ10 pills and placebo powder
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
D-ribose Only
n=33 participants at risk
Participants in this group will receive placebo pills and D-ribose oral powder.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
|
CoQ10 + D-ribose
n=33 participants at risk
Participants in this group will receive CoQ10 pills and D-ribose oral powder.
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Heart Failure
|
7.9%
3/38 • Number of events 3 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
5.7%
2/35 • Number of events 2 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
3.0%
1/33 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/38 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
3.0%
1/33 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/38 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/35 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
3.0%
1/33 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/38 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/35 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
6.1%
2/33 • Number of events 2 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
2.6%
1/38 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
9.1%
3/33 • Number of events 3 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
3.0%
1/33 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Infections and infestations
Skin infection
|
0.00%
0/38 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/35 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
3.0%
1/33 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Gastrointestinal disorders
Non-cardiac chest pain
|
0.00%
0/38 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/35 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
3.0%
1/33 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/38 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/35 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
3.0%
1/33 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/38 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.6%
1/38 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/35 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Nervous system disorders
Syncope
|
0.00%
0/38 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
5.7%
2/35 • Number of events 2 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/38 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
2.6%
1/38 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/38 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Cardiac disorders
Pericardial Effusion
|
2.6%
1/38 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/35 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Renal and urinary disorders
Renal Colic
|
2.6%
1/38 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/35 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
Other adverse events
| Measure |
Placebo Only
n=38 participants at risk
Participants in this group will receive placebo pills and placebo powder.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
CoQ10 Only
n=35 participants at risk
Participants in this group will receive CoQ10 pills and placebo powder
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
D-ribose Only
n=33 participants at risk
Participants in this group will receive placebo pills and D-ribose oral powder.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
|
CoQ10 + D-ribose
n=33 participants at risk
Participants in this group will receive CoQ10 pills and D-ribose oral powder.
CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/38 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/35 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
3.0%
1/33 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Infections and infestations
Bullous Dermatitis
|
0.00%
0/38 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/35 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
3.0%
1/33 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
1/38 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/35 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
3.0%
1/33 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/38 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
|
Cardiac disorders
Hypertension
|
2.6%
1/38 • Number of events 1 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/35 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
0.00%
0/33 • Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
|
Additional Information
Dr. Mario Medina, Director of Sponsored Programs Administration
Sponsored Programs Adminstration (SPA)
Phone: 913-588-5724
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place