Trial Outcomes & Findings for Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training) (NCT NCT02713126)
NCT ID: NCT02713126
Last Updated: 2023-04-26
Results Overview
Exercise capacity as measured by the peak rate of oxygen (VO2) consumption achieved during exercising testing. Peak VO2 is expressed as milliliters of oxygen per kilogram of body mass per minute.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
Baseline, 12 weeks
Results posted on
2023-04-26
Participant Flow
Participant milestones
| Measure |
Placebo
Subjects will undergo cardiac exercise training and receive inhaled or oral placebo three times per day for 12 weeks while wearing an accelerometer
Placebo: administered orally or inhaled, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
Sodium Nitrite
Subjects will undergo cardiac exercise training and receive inhaled or oral sodium nitrite three times per day for 12 weeks while wearing an accelerometer
Sodium Nitrite: administered orally or inhaled, 40 mg, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
56
|
|
Overall Study
COMPLETED
|
36
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training)
Baseline characteristics by cohort
| Measure |
Placebo
n=36 Participants
Subjects will undergo cardiac exercise training and receive inhaled or oral placebo three times per day for 12 weeks while wearing an accelerometer
Placebo: administered orally or inhaled, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
Sodium Nitrite
n=37 Participants
Subjects will undergo cardiac exercise training and receive inhaled or oral sodium nitrite three times per day for 12 weeks while wearing an accelerometer
Sodium Nitrite: administered orally or inhaled, 40 mg, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.5 years
n=5 Participants
|
72.0 years
n=7 Participants
|
72.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
37 participants
n=7 Participants
|
73 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksExercise capacity as measured by the peak rate of oxygen (VO2) consumption achieved during exercising testing. Peak VO2 is expressed as milliliters of oxygen per kilogram of body mass per minute.
Outcome measures
| Measure |
Placebo
n=34 Participants
Subjects will undergo cardiac exercise training and receive inhaled or oral placebo three times per day for 12 weeks while wearing an accelerometer
Placebo: administered orally or inhaled, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
Sodium Nitrite
n=31 Participants
Subjects will undergo cardiac exercise training and receive inhaled or oral sodium nitrite three times per day for 12 weeks while wearing an accelerometer
Sodium Nitrite: administered orally or inhaled, 40 mg, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
|---|---|---|
|
Change in Peak Rate of Oxygen (VO2)
|
0.85 ml/min/kg
Standard Deviation 2.10
|
0.70 ml/min/kg
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksThe change in daily activity levels as assessed by accelerometer data and reported as average accelerometry units.
Outcome measures
| Measure |
Placebo
n=27 Participants
Subjects will undergo cardiac exercise training and receive inhaled or oral placebo three times per day for 12 weeks while wearing an accelerometer
Placebo: administered orally or inhaled, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
Sodium Nitrite
n=22 Participants
Subjects will undergo cardiac exercise training and receive inhaled or oral sodium nitrite three times per day for 12 weeks while wearing an accelerometer
Sodium Nitrite: administered orally or inhaled, 40 mg, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
|---|---|---|
|
Change in Daily Activity Levels
|
-4 accelerometry units (AU)
Standard Deviation 51
|
23 accelerometry units (AU)
Standard Deviation 70
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksThe change in cardiac hemodynamics as measured by echocardiography. The E/e' ratio is a marker used to evaluate the left ventricular (LV) filling pressures during exercise. An E/e' ratio of \<8 is considered to be normal, a ratio \>15 is considered to reflect an increase in the LV filling pressure.
Outcome measures
| Measure |
Placebo
n=16 Participants
Subjects will undergo cardiac exercise training and receive inhaled or oral placebo three times per day for 12 weeks while wearing an accelerometer
Placebo: administered orally or inhaled, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
Sodium Nitrite
n=16 Participants
Subjects will undergo cardiac exercise training and receive inhaled or oral sodium nitrite three times per day for 12 weeks while wearing an accelerometer
Sodium Nitrite: administered orally or inhaled, 40 mg, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
|---|---|---|
|
Change in Cardiac Hemodynamics
|
1.1 ratio
Standard Deviation 3.2
|
-0.2 ratio
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksThe Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self-administered questionnaire that provides a measure of symptoms and physical limitations associated with heart failure. The overall summary score ranges from 0-100, where the higher the score the better the health status.
Outcome measures
| Measure |
Placebo
n=36 Participants
Subjects will undergo cardiac exercise training and receive inhaled or oral placebo three times per day for 12 weeks while wearing an accelerometer
Placebo: administered orally or inhaled, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
Sodium Nitrite
n=36 Participants
Subjects will undergo cardiac exercise training and receive inhaled or oral sodium nitrite three times per day for 12 weeks while wearing an accelerometer
Sodium Nitrite: administered orally or inhaled, 40 mg, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
|---|---|---|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
|
6.1 score on a scale
Standard Deviation 12.2
|
4.9 score on a scale
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksThe six minute walk test is an exercise test used to assess aerobic capacity and endurance. The total distance covered over six minutes is measured in meters.
Outcome measures
| Measure |
Placebo
n=35 Participants
Subjects will undergo cardiac exercise training and receive inhaled or oral placebo three times per day for 12 weeks while wearing an accelerometer
Placebo: administered orally or inhaled, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
Sodium Nitrite
n=36 Participants
Subjects will undergo cardiac exercise training and receive inhaled or oral sodium nitrite three times per day for 12 weeks while wearing an accelerometer
Sodium Nitrite: administered orally or inhaled, 40 mg, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
|---|---|---|
|
Change in Six Minute Walk Test
|
31 meters
Standard Deviation 37
|
37 meters
Standard Deviation 46
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
Sodium Nitrite
Serious events: 7 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=36 participants at risk
Subjects will undergo cardiac exercise training and receive inhaled or oral placebo three times per day for 12 weeks while wearing an accelerometer
Placebo: administered orally or inhaled, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
Sodium Nitrite
n=37 participants at risk
Subjects will undergo cardiac exercise training and receive inhaled or oral sodium nitrite three times per day for 12 weeks while wearing an accelerometer
Sodium Nitrite: administered orally or inhaled, 40 mg, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Severe Chest/Neck/Jaw Pain
|
2.8%
1/36 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
5.4%
2/37 • Number of events 2 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Serious Fall Resulting in Injury
|
2.8%
1/36 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
0.00%
0/37 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
Gastrointestinal disorders
GI Bleed
|
2.8%
1/36 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
0.00%
0/37 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Dizziness/Lightheadedness
|
2.8%
1/36 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
0.00%
0/37 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
Cardiac disorders
Shortness of Breath - Worsening Heart Failure
|
2.8%
1/36 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/36 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
5.4%
2/37 • Number of events 3 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Arrhythmia
|
0.00%
0/36 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
Cardiac disorders
Syncope/Stent placement
|
0.00%
0/36 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
Other adverse events
| Measure |
Placebo
n=36 participants at risk
Subjects will undergo cardiac exercise training and receive inhaled or oral placebo three times per day for 12 weeks while wearing an accelerometer
Placebo: administered orally or inhaled, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
Sodium Nitrite
n=37 participants at risk
Subjects will undergo cardiac exercise training and receive inhaled or oral sodium nitrite three times per day for 12 weeks while wearing an accelerometer
Sodium Nitrite: administered orally or inhaled, 40 mg, taken every 4 hours or 3 times per day during waking hours for 12 weeks
Accelerometer: External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
Cardiac Exercise Training: Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
|
|---|---|---|
|
General disorders
Cough
|
19.4%
7/36 • Number of events 8 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
27.0%
10/37 • Number of events 12 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Chest pain
|
22.2%
8/36 • Number of events 9 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
29.7%
11/37 • Number of events 14 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Dizziness
|
38.9%
14/36 • Number of events 19 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
59.5%
22/37 • Number of events 30 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Edema
|
2.8%
1/36 • Number of events 2 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
5.4%
2/37 • Number of events 2 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Fatigue
|
16.7%
6/36 • Number of events 10 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
8.1%
3/37 • Number of events 3 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
Gastrointestinal disorders
Upset stomach/diarrhea
|
13.9%
5/36 • Number of events 6 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
32.4%
12/37 • Number of events 16 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Headache
|
22.2%
8/36 • Number of events 8 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
27.0%
10/37 • Number of events 10 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Cold/SoreThroat/Flu
|
36.1%
13/36 • Number of events 14 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
35.1%
13/37 • Number of events 18 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
General Minor Injury - Fall/Bruise/Cut
|
11.1%
4/36 • Number of events 4 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
18.9%
7/37 • Number of events 8 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Miscellaneous - Blister/Bloody nose/Cataract/Dry Mouth/Acne
|
30.6%
11/36 • Number of events 12 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
54.1%
20/37 • Number of events 29 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Nausea
|
16.7%
6/36 • Number of events 8 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
13.5%
5/37 • Number of events 6 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Memory Loss
|
5.6%
2/36 • Number of events 2 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
0.00%
0/37 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Numbness/Pins and Needles
|
2.8%
1/36 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
Musculoskeletal and connective tissue disorders
Muscle and Joint Pain
|
30.6%
11/36 • Number of events 14 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
40.5%
15/37 • Number of events 17 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
Cardiac disorders
Palpitations
|
8.3%
3/36 • Number of events 3 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
0.00%
0/37 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Mood Changes - Depressed/Edgy/Forgetful
|
11.1%
4/36 • Number of events 4 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
5.4%
2/37 • Number of events 2 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
3/36 • Number of events 5 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
5.4%
2/37 • Number of events 2 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Shortness of Breath
|
16.7%
6/36 • Number of events 8 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
27.0%
10/37 • Number of events 14 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Bad Taste in Mouth
|
2.8%
1/36 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
5.4%
2/37 • Number of events 2 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Weight Gain
|
2.8%
1/36 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
5.4%
2/37 • Number of events 2 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/36 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
5.4%
2/37 • Number of events 2 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
Gastrointestinal disorders
Black Stool
|
0.00%
0/36 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
General disorders
Worsening Renal Function
|
0.00%
0/36 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
|
Cardiac disorders
Revascularization
|
0.00%
0/36 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
|
2.7%
1/37 • Number of events 1 • Adverse events were collected from the initiation of any study procedures to the end of the study treatment follow-up, approximately a total of 14 weeks for each participant.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place