Trial Outcomes & Findings for Biomarker Guided Therapies in Stage A/B Heart Failure (NCT NCT02230891)

Last Updated: 2022-10-21

Results Overview

Change in myocardial speckle tracked strain (global longitudinal strain) after 18 months (baseline vs. 18 months) of therapy with carvedilol or spironolactone or usual care. The myocardial global longitudinal strain was measured using echocardiography

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

18 months

Results posted on

2022-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Carvedilol Approximately 70 subjects will be randomized to carvedilol Carvedilol: Carvedilol is a non selective beta blocker. Dose will be 3.125 mg two times daily with increases in dose if blood pressure permits	Spironolactone Approximately 70 subjects will be randomized to spironolactone Spironolactone: Spironolactone is an aldosterone antagonist and can lower blood pressure/ is used in heart failure. Spironolactone dose will be 25 mg by mouth once daily	Usual Care Approximately 70 subjects will be randomized to usual care/ standard care by primary care providers Usual care: standard care as per primary care provider
Baseline STARTED	21	18	19
Baseline COMPLETED	21	17	18
Baseline NOT COMPLETED	0	1	1
2 Week STARTED	21	17	0
2 Week COMPLETED	18	15	0
2 Week NOT COMPLETED	3	2	0
6 Month STARTED	18	15	18
6 Month COMPLETED	17	12	17
6 Month NOT COMPLETED	1	3	1
12 Month STARTED	17	12	17
12 Month COMPLETED	16	9	17
12 Month NOT COMPLETED	1	3	0
18 Month End of Study STARTED	16	9	17
18 Month End of Study COMPLETED	15	9	16
18 Month End of Study NOT COMPLETED	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Carvedilol Approximately 70 subjects will be randomized to carvedilol Carvedilol: Carvedilol is a non selective beta blocker. Dose will be 3.125 mg two times daily with increases in dose if blood pressure permits	Spironolactone Approximately 70 subjects will be randomized to spironolactone Spironolactone: Spironolactone is an aldosterone antagonist and can lower blood pressure/ is used in heart failure. Spironolactone dose will be 25 mg by mouth once daily	Usual Care Approximately 70 subjects will be randomized to usual care/ standard care by primary care providers Usual care: standard care as per primary care provider
Baseline Did not meet inclusion	0	1	1
2 Week Withdrawal by Subject	2	2	0
2 Week Consent withdrawn	1	0	0
6 Month Withdrawal by Subject	1	1	1
6 Month Physician Decision	0	2	0
12 Month Death	1	0	0
12 Month Lost to Follow-up	0	1	0
12 Month Withdrawal by Subject	0	2	0
18 Month End of Study Death	0	0	1
18 Month End of Study Hear failure, lost to follow up	1	0	0

Baseline Characteristics

One subject baseline biomarker not available

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 18 months

Population: Difference is global longitudinal strain between baseline and 18 months for those who completed both visits and had data available

Outcome measures

Outcome measures
Measure	Carvedilol n=15 Participants Approximately 70 subjects will be randomized to carvedilol Carvedilol: Carvedilol is a non selective beta blocker	Spironolactone n=9 Participants Approximately 70 subjects will be randomized to spironolactone Spironolactone: Spironolactone is an aldosterone antagonist and can lower blood pressure/ is used in heart failure	Usual Care n=13 Participants Approximately 70 subjects will be randomized to usual care/ standard care by primary care providers Usual care: standard care as per primary care provider
Change in Cardiac Global Longitudinal Strain	-1.4 % systolic deformation Standard Deviation 4.4	-1.74 % systolic deformation Standard Deviation 3.25	-1.14 % systolic deformation Standard Deviation 4.13

SECONDARY outcome

Timeframe: 18 months

Population: Those who completed study and had data available

Change in levels of NT-proBNP (measured in blood samples) between baseline and 18 months after therapy with carvedilol or spironolactone or usual care

Outcome measures

Outcome measures
Measure	Carvedilol n=15 Participants Approximately 70 subjects will be randomized to carvedilol Carvedilol: Carvedilol is a non selective beta blocker	Spironolactone n=8 Participants Approximately 70 subjects will be randomized to spironolactone Spironolactone: Spironolactone is an aldosterone antagonist and can lower blood pressure/ is used in heart failure	Usual Care n=14 Participants Approximately 70 subjects will be randomized to usual care/ standard care by primary care providers Usual care: standard care as per primary care provider
Change in NTproBNP (Biomarker)	87.9 pg/ml Standard Deviation 243.5	-16.5 pg/ml Standard Deviation 39.3	3.65 pg/ml Standard Deviation 91.03

SECONDARY outcome

Timeframe: 18 months

Population: Based on available measures at baseline and end of study. Reported values are change in Pulse wave velocity (PWV) between visits

Changes in arterial stiffness between baseline and 18 months after therapy with carvedilol, spironolactone or usual care. Arterial stiffness was measured by pulse wave velocity (Sphygmocor device)

Outcome measures

Outcome measures
Measure	Carvedilol n=10 Participants Approximately 70 subjects will be randomized to carvedilol Carvedilol: Carvedilol is a non selective beta blocker	Spironolactone n=8 Participants Approximately 70 subjects will be randomized to spironolactone Spironolactone: Spironolactone is an aldosterone antagonist and can lower blood pressure/ is used in heart failure	Usual Care n=11 Participants Approximately 70 subjects will be randomized to usual care/ standard care by primary care providers Usual care: standard care as per primary care provider
Change in Pulse Wave Velocity	-0.71 m/sec Standard Deviation 1.6	-0.77 m/sec Standard Deviation 5.7	-0.59 m/sec Standard Deviation 3.4

SECONDARY outcome

Timeframe: 18 months

Population: Those who completed study and had data available

Change in levels of troponin T (measured with a high sensitivity assay in blood samples) between baseline and 18 months after therapy with carvedilol or spironolactone or usual care

Outcome measures

Outcome measures
Measure	Carvedilol n=15 Participants Approximately 70 subjects will be randomized to carvedilol Carvedilol: Carvedilol is a non selective beta blocker	Spironolactone n=8 Participants Approximately 70 subjects will be randomized to spironolactone Spironolactone: Spironolactone is an aldosterone antagonist and can lower blood pressure/ is used in heart failure	Usual Care n=14 Participants Approximately 70 subjects will be randomized to usual care/ standard care by primary care providers Usual care: standard care as per primary care provider
Change in Troponin T Measured Using a High Sensitivity Assay	-0.2 ng/L Standard Deviation 5.2	1.4 ng/L Standard Deviation 3.9	0.35 ng/L Standard Deviation 6.0

Adverse Events

Carvedilol

Serious events: 6 serious events

Other events: 14 other events

Deaths: 1 deaths

Spironolactone

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Usual Care

Serious events: 3 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Carvedilol n=21 participants at risk Approximately 70 subjects will be randomized to carvedilol Carvedilol: Carvedilol is a non selective beta blocker	Spironolactone n=18 participants at risk Approximately 70 subjects will be randomized to spironolactone Spironolactone: Spironolactone is an aldosterone antagonist and can lower blood pressure/ is used in heart failure	Usual Care n=19 participants at risk Approximately 70 subjects will be randomized to usual care/ standard care by primary care providers Usual care: standard care as per primary care provider
General disorders Hospitalization for planned surgery	4.8% 1/21 • Number of events 1 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	5.6% 1/18 • Number of events 2 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	10.5% 2/19 • Number of events 2 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Infections and infestations Hospitalization for infection	0.00% 0/21 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	11.1% 2/18 • Number of events 3 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	10.5% 2/19 • Number of events 2 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Musculoskeletal and connective tissue disorders Hospitalization for falls, accidents	14.3% 3/21 • Number of events 3 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	5.6% 1/18 • Number of events 1 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	0.00% 0/19 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Cardiac disorders Hospitalization for chest pain/ heart failure	19.0% 4/21 • Number of events 4 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	0.00% 0/18 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	0.00% 0/19 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Cardiac disorders Hypotension, ER visit	9.5% 2/21 • Number of events 2 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	11.1% 2/18 • Number of events 2 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	0.00% 0/19 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Respiratory, thoracic and mediastinal disorders Hospitalization for shortness of breath	0.00% 0/21 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	0.00% 0/18 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	5.3% 1/19 • Number of events 1 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)

Other adverse events

Other adverse events
Measure	Carvedilol n=21 participants at risk Approximately 70 subjects will be randomized to carvedilol Carvedilol: Carvedilol is a non selective beta blocker	Spironolactone n=18 participants at risk Approximately 70 subjects will be randomized to spironolactone Spironolactone: Spironolactone is an aldosterone antagonist and can lower blood pressure/ is used in heart failure	Usual Care n=19 participants at risk Approximately 70 subjects will be randomized to usual care/ standard care by primary care providers Usual care: standard care as per primary care provider
Endocrine disorders Breast tenderness	0.00% 0/21 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	16.7% 3/18 • Number of events 3 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	0.00% 0/19 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Renal and urinary disorders Renal dysfunction	0.00% 0/21 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	16.7% 3/18 • Number of events 3 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	5.3% 1/19 • Number of events 2 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Gastrointestinal disorders abdominal discomfort	14.3% 3/21 • Number of events 3 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	5.6% 1/18 • Number of events 1 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	0.00% 0/19 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Cardiac disorders Dizziness/ Drowsiness/ Disequilibrium	9.5% 2/21 • Number of events 2 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	16.7% 3/18 • Number of events 4 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	10.5% 2/19 • Number of events 3 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	14.3% 3/21 • Number of events 3 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	11.1% 2/18 • Number of events 2 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	31.6% 6/19 • Number of events 10 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Cardiac disorders chest pain	14.3% 3/21 • Number of events 4 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	5.6% 1/18 • Number of events 1 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	5.3% 1/19 • Number of events 2 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Musculoskeletal and connective tissue disorders Fatigue	9.5% 2/21 • Number of events 2 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	5.6% 1/18 • Number of events 1 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	0.00% 0/19 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Nervous system disorders Falls	9.5% 2/21 • Number of events 2 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	0.00% 0/18 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	5.3% 1/19 • Number of events 1 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Endocrine disorders Weight loss	0.00% 0/21 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	11.1% 2/18 • Number of events 2 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	5.3% 1/19 • Number of events 1 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)
Cardiac disorders Atrial arrhythmia	9.5% 2/21 • Number of events 2 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	0.00% 0/18 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)	5.3% 1/19 • Number of events 1 • The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects)

Additional Information

Vijay Nambi

Michael E DeBakey Veterans Affairs Hospital

Phone: 713-794-7300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Carvedilol n=20 Participants Approximately 70 subjects will be randomized to carvedilol Carvedilol: Carvedilol is a non selective beta blocker	Spironolactone n=18 Participants Approximately 70 subjects will be randomized to spironolactone Spironolactone: Spironolactone is an aldosterone antagonist and can lower blood pressure/ is used in heart failure	Usual Care n=18 Participants Approximately 70 subjects will be randomized to usual care/ standard care by primary care providers Usual care: standard care as per primary care provider	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=56 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=20 Participants	4 Participants n=18 Participants	3 Participants n=18 Participants	8 Participants n=56 Participants
Age, Categorical >=65 years	19 Participants n=20 Participants	14 Participants n=18 Participants	15 Participants n=18 Participants	48 Participants n=56 Participants
Age, Continuous	70.6 years STANDARD_DEVIATION 5.3 • n=20 Participants	69.2 years STANDARD_DEVIATION 6.5 • n=18 Participants	70.6 years STANDARD_DEVIATION 5.8 • n=18 Participants	70.1 years STANDARD_DEVIATION 5.8 • n=56 Participants
Sex: Female, Male Female	0 Participants n=20 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=56 Participants
Sex: Female, Male Male	20 Participants n=20 Participants	18 Participants n=18 Participants	18 Participants n=18 Participants	56 Participants n=56 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=56 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=56 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=56 Participants
Race (NIH/OMB) Black or African American	12 Participants n=20 Participants	9 Participants n=18 Participants	5 Participants n=18 Participants	26 Participants n=56 Participants
Race (NIH/OMB) White	8 Participants n=20 Participants	9 Participants n=18 Participants	13 Participants n=18 Participants	30 Participants n=56 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=56 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=18 Participants	0 Participants n=18 Participants	0 Participants n=56 Participants
Region of Enrollment United States	20 participants n=20 Participants	18 participants n=18 Participants	18 participants n=18 Participants	58 participants n=56 Participants
Baseline troponin	14.6 ng/L STANDARD_DEVIATION 3.3 • n=19 Participants • One subject baseline biomarker not available	15.4 ng/L STANDARD_DEVIATION 4.6 • n=18 Participants • One subject baseline biomarker not available	17.1 ng/L STANDARD_DEVIATION 4.4 • n=18 Participants • One subject baseline biomarker not available	15.7 ng/L STANDARD_DEVIATION 4.2 • n=55 Participants • One subject baseline biomarker not available
N-terminal (NT)-pro hormone BNP (NT-proBNP)	97.0 pg/ml STANDARD_DEVIATION 78.7 • n=19 Participants • One subject baseline biomarker not available	72.2 pg/ml STANDARD_DEVIATION 73.5 • n=18 Participants • One subject baseline biomarker not available	96.6 pg/ml STANDARD_DEVIATION 76.4 • n=18 Participants • One subject baseline biomarker not available	88.7 pg/ml STANDARD_DEVIATION 75.7 • n=55 Participants • One subject baseline biomarker not available
Pulse wave velocity (PWV)	10.6 m/sec STANDARD_DEVIATION 4.9 • n=14 Participants • Based on available data for analysis	9.4 m/sec STANDARD_DEVIATION 5.5 • n=14 Participants • Based on available data for analysis	8.5 m/sec STANDARD_DEVIATION 4.1 • n=13 Participants • Based on available data for analysis	9.5 m/sec STANDARD_DEVIATION 4.8 • n=41 Participants • Based on available data for analysis