What side effects are associated with this type of intervention?

Beta-blockers, such as bisoprolol, metoprolol, and carvedilol, are commonly used to treat hypertension by reducing heart rate and blood pressure. Known side effects of beta-blockers include fatigue, cold extremities, weight gain, and in some cases, depression and sleep disturbances. Other common antihypertensive treatments include ACE inhibitors, which can cause a persistent dry cough and elevated blood potassium levels; diuretics, which may lead to electrolyte imbalances and dehydration; and calcium channel blockers, which can cause swelling in the lower extremities, dizziness, and constipation.

What prior FDA approvals exist?

Beta-blockers, such as carvedilol, metoprolol succinate, and bisoprolol, have been approved by the FDA for the treatment of hypertension. These medications work by blocking the effects of epinephrine, which helps to reduce heart rate and blood pressure. Carvedilol is often preferred in patients with heart failure and poorly controlled diabetes due to its favorable effects on glycemic control. Metoprolol succinate and bisoprolol are also widely used and have demonstrated efficacy in reducing mortality in patients with heart failure. These drugs are part of a broader class of antihypertensive medications that have been systematically studied and approved for use in both adults and children.

What other types of research exist?

Promising novel alternatives to beta-blockers for hypertension treatment in 2024 include SGLT2 inhibitors, which have shown cardiovascular benefits, and mineralocorticoid receptor antagonists like eplerenone. These agents offer different mechanisms of action and may provide additional benefits beyond blood pressure reduction.

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Beta Blocker

Beta-Blockers for Hypertension in African-Americans

Q: What is the mechanism of action of this treatment?

Beta-blockers, such as metoprolol and carvedilol, work by blocking the effects of epinephrine (adrenaline), which reduces heart rate and dilates blood vessels, thereby lowering blood pressure. ACE inhibitors (e.g., ramipril) and ARBs (e.g., valsartan) inhibit the renin-angiotensin-aldosterone system, leading to vasodilation and reduced blood volume. Calcium channel blockers (e.g., amlodipine) prevent calcium from entering heart and blood vessel cells, causing relaxation of the blood vessels. Diuretics (e.g., hydrochlorothiazide) help the kidneys remove excess sodium and water from the body, reducing blood volume. These mechanisms are crucial for hypertension patients as they help manage blood pressure, reducing the risk of cardiovascular events such as heart attacks and strokes.

Phase 2

Waitlist Available

Led By Pankaj Arora, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 40 years

Be between 18 and 65 years old

Must not have

Pregnant or use of Hormone Replacement Therapy (HRT) or oral contraceptives (OCP) or steroids

History of hypertension or use of BP lowering medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 20 minutes of the standardized exercise challenge at 70% of their maximal oxygen uptake

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how a beta-blocker (metoprolol) and exercise affect heart hormones in healthy African-American and Caucasian individuals with normal or slightly high blood pressure. It aims to understand why African-Americans may respond differently to these treatments. Metoprolol has been studied extensively for its effects on blood pressure and heart rate during rest and exercise.

Who is the study for?

This trial is for healthy individuals aged 18-40 with normal blood pressure and BMI, who can perform an exercise test. It's not for those with heart disease, hypertension medication use, very low blood pressure or heart rate, depression, diabetes, kidney issues, smokers or pregnant women using certain hormones.

What is being tested?

The study investigates how African-Americans respond to a beta-blocker called Metoprolol Succinate ER during exercise challenges and after standardized meals. The goal is to understand racial differences in cardiovascular risk.

What are the potential side effects?

Potential side effects of Metoprolol include tiredness, dizziness upon standing up too fast due to lowered blood pressure, cold hands and feet from reduced circulation, trouble sleeping or nightmares.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant and do not use HRT, OCPs, or steroids.

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I have high blood pressure or take medication to lower it.

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I have a history of heart disease or take medication for it.

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My kidney function is reduced (eGFR < 60).

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I have diabetes or take medication for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 20 minutes of the standardized exercise challenge at 70% of their maximal oxygen uptak

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 20 minutes of the standardized exercise challenge at 70% of their maximal oxygen uptak

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 20 minutes of the standardized exercise challenge at 70% of their maximal oxygen uptak for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Plasma BNP After 6-weeks of Beta-Blocker

Change in Plasma MR-proANP After 6-weeks of Beta-Blocker

Change in Plasma NT-proBNP After 6-weeks of Beta-Blocker

Secondary study objectives

Change in Plasma BNP After Exercise

Change in Plasma MR-proANP After Exercise

Change in Plasma NT-proBNP After Exercise

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Black ParticipantsExperimental Treatment4 Interventions

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 II: White ParticipantsActive Control4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metoprolol Succinate ER

2017

Completed Phase 2

~80

Standardized meals

2017

Completed Phase 2

~80

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Beta-blockers, such as metoprolol and carvedilol, work by blocking the effects of epinephrine (adrenaline), which reduces heart rate and dilates blood vessels, thereby lowering blood pressure. ACE inhibitors (e.g., ramipril) and ARBs (e.g., valsartan) inhibit the renin-angiotensin-aldosterone system, leading to vasodilation and reduced blood volume. Calcium channel blockers (e.g., amlodipine) prevent calcium from entering heart and blood vessel cells, causing relaxation of the blood vessels. Diuretics (e.g., hydrochlorothiazide) help the kidneys remove excess sodium and water from the body, reducing blood volume. These mechanisms are crucial for hypertension patients as they help manage blood pressure, reducing the risk of cardiovascular events such as heart attacks and strokes.

Effects of beta-blocker therapy on mortality in patients with heart failure. A systematic overview of randomized controlled trials.