Beta-Blockers for Hypertension in African-Americans

Overseen By Nehal Vekariya, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

Must not be taking: CVD medications, BP medications, Antidiabetics, Steroids

Disqualifiers: Cardiovascular disease, Hypertension, Diabetes, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants do not use medications for cardiovascular disease, blood pressure, diabetes, or hormone replacement therapy. If you are taking any of these, you would need to stop before joining the study.

Is Metoprolol Succinate ER safe for humans?

Metoprolol Succinate ER has been shown to be generally safe in humans, with studies indicating good tolerability in both children with high blood pressure and adults with heart failure. The extended-release formulation helps maintain steady drug levels, which reduces side effects and improves patient compliance. ^{1 2 3 4 5}

How does the drug Metoprolol Succinate ER differ from other treatments for hypertension in African-Americans?

Metoprolol Succinate ER is a selective beta-blocker designed to provide consistent blood levels with once-daily dosing, which may improve patient compliance and reduce side effects compared to nonselective beta-blockers. While beta-blockers are generally less effective as monotherapy in African-Americans, Metoprolol Succinate ER's extended-release formulation offers a more stable effect, potentially enhancing its efficacy when used in combination with other treatments. ^{1 2 6 7 8}

What data supports the effectiveness of the drug Metoprolol Succinate ER for hypertension in African-Americans?

Research indicates that Metoprolol, a type of beta-blocker, has been effective and well-tolerated in black patients with heart failure, suggesting potential benefits for hypertension as well. Additionally, beta-blockers with specific properties have shown effectiveness in black patients with hypertension, indicating that Metoprolol may also be beneficial. ^{6 7 9 10 11}

Research Team

Pankaj Arora, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

Your weight is within a certain range based on your height.

Willing to adhere to study drug

Your blood pressure is lower than 140/90 mm Hg.

Exclusion Criteria

Your heart beats less than 60 times per minute.

You currently smoke or have smoked in the past.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Exercise Challenge

Participants perform exercise capacity VO2 max determination test followed by a standardized exercise challenge test

1 week

2 visits (in-person)

Treatment

Participants receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day

6 weeks

Bi-weekly visits (in-person)

Follow-up

Participants are monitored for changes in plasma BNP, NT-proBNP, and MR-proANP levels after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Metoprolol Succinate ER

Trial Overview 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.

Participant Groups

Group I: Black Participants Experimental Treatment 4 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 Participants Active Control 4 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

In a study of 60 patients over 6 months, metoprolol succinate was found to be safe and well tolerated, with no significant differences in quality of life or withdrawal rates compared to placebo.

Patients taking metoprolol succinate experienced a significant increase in left ventricular ejection fraction and a reduction in ventricular ectopic beats, indicating improved heart function and rhythm stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metoprolol CR/XL in patients with heart failure: A pilot study examining the tolerability, safety, and effect on left ventricular ejection fraction. Goldstein, S., Kennedy, HL., Hall, C., et al.[2019]

In a 36-month study involving patients with hypercholesterolemia, metoprolol CR/XL significantly reduced the progression of carotid intima-media thickness (IMT) compared to placebo, indicating its potential antiatherosclerotic effect when used alongside statins.

The study suggests that beta-blockers like metoprolol and statins work through different mechanisms in the atherosclerotic process, providing additive benefits for patients undergoing lipid-lowering therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of controlled release/extended release metoprolol on carotid intima-media thickness in patients with hypercholesterolemia: a 3-year randomized study. Wiklund, O., Hulthe, J., Wikstrand, J., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of beta-adrenergic receptor blockers in blacks. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Beta blockers, hypertension, and blacks--is the answer really in? [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Metoprolol CR/XL in black patients with heart failure (from the Metoprolol CR/XL randomized intervention trial in chronic heart failure). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Pathophysiologic and pharmacotherapy considerations in the management of the black hypertensive patient. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Racial differences in mortality in patients with advanced systolic heart failure: potential role of right ventricular ejection fraction. [2021]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Metoprolol CR/XL: advanced formulation of a classical beta-blocker]. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of extended release metoprolol succinate in hypertensive children 6 to 16 years of age: a clinical trial experience. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Metoprolol CR/XL in patients with heart failure: A pilot study examining the tolerability, safety, and effect on left ventricular ejection fraction. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetic considerations of formulation: extended-release metoprolol succinate in the treatment of heart failure. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Metoprolol succinate combination in the treatment of hypertension. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of controlled release/extended release metoprolol on carotid intima-media thickness in patients with hypercholesterolemia: a 3-year randomized study. [2019]