Trial Outcomes & Findings for Race, Natriuretic Peptides and Physiological Perturbations (NCT NCT03070184)
NCT ID: NCT03070184
Last Updated: 2025-03-12
Results Overview
Mean percentage change in plasma BNP concentrations in response to 6 weeks of Beta-Blocker between Black participants and White participants
COMPLETED
PHASE2
80 participants
6 weeks
2025-03-12
Participant Flow
Participant milestones
| Measure |
Black Participants
Healthy lean (BMI 18-25 kg/m2) African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
White Participants
Healthy lean (BMI 18-25 kg/m2) white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cardiac function parameters where only collected for a limited number of participants
Baseline characteristics by cohort
| Measure |
Black Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
White Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27 years
n=40 Participants
|
25 years
n=40 Participants
|
26 years
n=80 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=40 Participants
|
19 Participants
n=40 Participants
|
40 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=40 Participants
|
21 Participants
n=40 Participants
|
40 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=40 Participants
|
40 Participants
n=40 Participants
|
80 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=80 Participants
|
|
Body Mass Index (BMI)
|
25.1 kg/m²
n=40 Participants
|
24.1 kg/m²
n=40 Participants
|
24.5 kg/m²
n=80 Participants
|
|
Systolic Blood Pressure (SBP)
|
109 mmHg
n=40 Participants
|
108 mmHg
n=40 Participants
|
109 mmHg
n=80 Participants
|
|
Diastolic Blood Pressure (DBP)
|
67 mmHg
n=40 Participants
|
70 mmHg
n=40 Participants
|
69 mmHg
n=80 Participants
|
|
Heart Rate
|
69 beats per minute
n=40 Participants
|
70 beats per minute
n=40 Participants
|
70 beats per minute
n=80 Participants
|
|
Fasting Glucose
|
83.0 mg/dL
n=40 Participants
|
86.5 mg/dL
n=40 Participants
|
85.0 mg/dL
n=80 Participants
|
|
Hemoglobin
|
13.3 g/dL
n=40 Participants
|
14.1 g/dL
n=40 Participants
|
13.5 g/dL
n=80 Participants
|
|
Insulin
|
6.5 mg/dL
n=40 Participants
|
5.9 mg/dL
n=40 Participants
|
6.2 mg/dL
n=80 Participants
|
|
Creatinine
|
1.0 mg/dL
n=40 Participants
|
0.9 mg/dL
n=40 Participants
|
0.9 mg/dL
n=80 Participants
|
|
Aspartate Aminotransferase (AST)
|
17.0 U/L
n=40 Participants
|
17.0 U/L
n=40 Participants
|
17.0 U/L
n=80 Participants
|
|
Alanine Aminotransferase (ALT)
|
14.0 U/L
n=40 Participants
|
14.5 U/L
n=40 Participants
|
14.0 U/L
n=80 Participants
|
|
Midregional pro- Atrial Natriuretic Peptide (MRproANP)
|
43 pmol/L
n=40 Participants
|
47 pmol/L
n=40 Participants
|
44 pmol/L
n=80 Participants
|
|
B-type Natriuretic Peptide (BNP)
|
16.0 ng/L
n=40 Participants
|
15.0 ng/L
n=40 Participants
|
15.0 ng/L
n=80 Participants
|
|
N-terminal pro-Btype Natriuretic Peptide (NTproBNP)
|
17 ng/L
n=40 Participants
|
20 ng/L
n=40 Participants
|
19 ng/L
n=80 Participants
|
|
Left Ventricular Hypertrophy
|
0.0 Percentage of Participants
n=21 Participants • Cardiac function parameters where only collected for a limited number of participants
|
6.7 Percentage of Participants
n=30 Participants • Cardiac function parameters where only collected for a limited number of participants
|
3.9 Percentage of Participants
n=51 Participants • Cardiac function parameters where only collected for a limited number of participants
|
|
Left Atrial Enlargement
|
4.8 Percentage of Participants
n=21 Participants • Cardiac function parameters where only collected for a limited number of participants
|
23.3 Percentage of Participants
n=30 Participants • Cardiac function parameters where only collected for a limited number of participants
|
15.7 Percentage of Participants
n=51 Participants • Cardiac function parameters where only collected for a limited number of participants
|
PRIMARY outcome
Timeframe: 6 weeksMean percentage change in plasma BNP concentrations in response to 6 weeks of Beta-Blocker between Black participants and White participants
Outcome measures
| Measure |
Black Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
White Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
|---|---|---|
|
Change in Plasma BNP After 6-weeks of Beta-Blocker
|
45 Percentage Change in Plasma BNP levels
Interval 7.0 to 95.0
|
74 Percentage Change in Plasma BNP levels
Interval 30.0 to 133.0
|
PRIMARY outcome
Timeframe: 6 weeksMean percentage change in plasma NT-proBNP concentrations in response to 6 weeks of Beta-Blocker between Black participants and White participants
Outcome measures
| Measure |
Black Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
White Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
|---|---|---|
|
Change in Plasma NT-proBNP After 6-weeks of Beta-Blocker
|
95 Percentage Change in Plasma NT-proBNP
Interval 31.0 to 190.0
|
99 Percentage Change in Plasma NT-proBNP
Interval 35.0 to 193.0
|
PRIMARY outcome
Timeframe: 6 weeksMean percentage change in plasma MR-proANP concentrations in response to 6 weeks of Beta-Blocker between Black participants and White participants
Outcome measures
| Measure |
Black Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
White Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
|---|---|---|
|
Change in Plasma MR-proANP After 6-weeks of Beta-Blocker
|
18 Percentage Change in Plasma MR-proANP
Interval -5.0 to 47.0
|
16 Percentage Change in Plasma MR-proANP
Interval -6.0 to 44.0
|
SECONDARY outcome
Timeframe: Mean percentage change in plasma BNP concentrations from baseline to 20 minutes post-exercise (immediately after exercise)Mean percentage change in plasma BNP concentrations in response to exercise
Outcome measures
| Measure |
Black Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
White Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
|---|---|---|
|
Change in Plasma BNP After Standardized Exercise Challenge
|
59 Percentage change in Plasma BNP
Interval 14.0 to 114.0
|
61 Percentage change in Plasma BNP
Interval 20.0 to 116.0
|
SECONDARY outcome
Timeframe: Mean percentage change in plasma NT-proBNP concentrations from baseline to 20 minutes post-exercise (immediately after exercise)Mean percentage change in plasma NT-proBNP concentrations in response to exercise
Outcome measures
| Measure |
Black Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
White Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
|---|---|---|
|
Change in Plasma NT-proBNP After Standardized Exercise Challenge
|
11 Percentage change in Plasma NT-proBNP
Interval -28.0 to 69.0
|
23 Percentage change in Plasma NT-proBNP
Interval 20.0 to 87.0
|
SECONDARY outcome
Timeframe: Mean percentage change in plasma MR-proANP concentrations from baseline to 20 minutes post-exercise (immediately after exercise)Mean percentage change in plasma MR-proANP concentrations in response to exercise
Outcome measures
| Measure |
Black Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
White Participants
n=40 Participants
Healthy lean (BMI 18-25 kg/m2) white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
|---|---|---|
|
Change in Plasma MR-proANP After Standardized Exercise Challenge
|
35 Percentage change in Plasma MR-proANP
Interval 8.0 to 68.0
|
43 Percentage change in Plasma MR-proANP
Interval 15.0 to 78.0
|
Adverse Events
Black Participants
White Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Black Participants
n=40 participants at risk
Healthy lean (BMI 18-25 kg/m2) African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
White Participants
n=40 participants at risk
Healthy lean (BMI 18-25 kg/m2) white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will perform exercise capacity VO2 max determination test, followed by 3 days of standardized meals and exercise challenge test. After exercise challenge test, all the participants will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day.
Exercise capacity VO2 max determination: Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
Standardized meals: Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
Exercise challenge: Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
Metoprolol Succinate ER: Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
|
|---|---|---|
|
Nervous system disorders
Headache
|
15.0%
6/40 • Number of events 6 • Adverse events were collected after the completion of the screening visit, during the exercise visits, and during the Beta-Blocker intervention period for a total of 14 weeks
|
17.5%
7/40 • Number of events 7 • Adverse events were collected after the completion of the screening visit, during the exercise visits, and during the Beta-Blocker intervention period for a total of 14 weeks
|
|
Gastrointestinal disorders
Nausea
|
12.5%
5/40 • Number of events 5 • Adverse events were collected after the completion of the screening visit, during the exercise visits, and during the Beta-Blocker intervention period for a total of 14 weeks
|
15.0%
6/40 • Number of events 6 • Adverse events were collected after the completion of the screening visit, during the exercise visits, and during the Beta-Blocker intervention period for a total of 14 weeks
|
|
Nervous system disorders
Vasovagal Response
|
5.0%
2/40 • Number of events 2 • Adverse events were collected after the completion of the screening visit, during the exercise visits, and during the Beta-Blocker intervention period for a total of 14 weeks
|
7.5%
3/40 • Number of events 3 • Adverse events were collected after the completion of the screening visit, during the exercise visits, and during the Beta-Blocker intervention period for a total of 14 weeks
|
Additional Information
Nehal Vekariya, MS - Clinical Research Coordinator III
The University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place