Race, Natriuretic Peptides and Physiological Perturbations

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-30

Study Completion Date

2024-04-30

Brief Summary

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The purpose of the study is to understand the origins of differential response to beta-blockers in African-Americans and may provide insight regarding racial differences in cardiovascular risk.

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Detailed Description

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The heart is an endocrine organ. The natriuretic peptides are hormones produced in the heart and are secreted in response to increased wall stress in atria and ventricles. The principal circulating NPs are Atrial Natriuretic Peptide (ANP) and B-type Natriuretic Peptide (BNP). The endocrine actions of NPs are natriuresis and dilatation of peripheral arteries.

The NPs concentrations are elevated in heart failure (HF) and hypertension (HTN) due to volume and pressure overload. Therefore, NPs are used as diagnostic and prognostic markers in heart failure. However, NPs role in healthy individuals is not known.

Previous studies have shown that reduced NP levels are associated with a greater risk of HTN. Moreover, African-Americans have lower resting NP levels than Caucasians. We hypothesize that relative NP deficiency in African American compared to Caucasian has the potential to contribute to increase risk of all-cause mortality, HTN, HF and its sequelae.

Evidence from multiple clinical trials has positioned beta-blockers as a standard heart failure therapy. Beta-blocker therapy leads to increased NP levels and suppression of Renin-aldosterone-angiotensin system (RAAS) system. Suppression of renin levels by beta-blockers has been shown as a potential mechanism of benefit in HF. However, study shows that beta-blockers are less effective in African-Americans compared to Caucasians in HF treatment. So, the investigators have proposed a pilot study to look for race-based differences in the NP and RAAS response to metoprolol in healthy individuals.

Additionally, exercise has been reported to increase NP levels. ANP increases more than BNP with exercise. But there is no data of NP changes in African-American with exercise. So the investigators have proposed a sub-study of race-based difference in ANP and BNP response to exercise.

40 African-American and 40 Caucasians normotensive or pre-hypertensive (healthy) individuals will be enrolled.

Conditions

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Healthy Pre Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise capacity VO2 max determination

Intervention Type OTHER

Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.

Standardized meals

Intervention Type DIETARY_SUPPLEMENT

Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).

Exercise challenge

Intervention Type OTHER

Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.

Metoprolol Succinate ER

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Exercise capacity VO2 max determination

Intervention Type OTHER

Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.

Standardized meals

Intervention Type DIETARY_SUPPLEMENT

Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).

Exercise challenge

Intervention Type OTHER

Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.

Metoprolol Succinate ER

Intervention Type DRUG

Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.

Interventions

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Exercise capacity VO2 max determination

Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.

Intervention Type OTHER

Standardized meals

Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).

Intervention Type DIETARY_SUPPLEMENT

Exercise challenge

Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.

Intervention Type OTHER

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 to 40 years
* Blood pressure less than 140/90 mm Hg
* Able to perform exercise capacity test
* BMI 18-30 kg/m2
* Willing to adhere to study drug

Exclusion Criteria

* History of cardiovascular disease or use of medications for CVD
* History of hypertension or use of BP lowering medications
* Blood pressure less than 100/60 mm Hg
* Heart rate less than 60 beats/min
* Depression
* Diabetes or use of anti-diabetic medications
* Renal disease (eGFR \< 60ml/min/1.73m2)
* Current or prior smokers
* Pregnant or use of Hormone Replacement Therapy (HRT) or oral contraceptives (OCP) or steroids

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes