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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why African-Americans respond differently to beta-blockers, a type of medication used to manage high blood pressure. Participants will receive metoprolol succinate (a beta-blocker) and undergo tests to study its effects on cardiovascular health. The trial includes both African-American and white participants for comparison. Individuals with stable blood pressure below 140/90 mm Hg who can perform an exercise test might be a good fit. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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 there any evidence suggesting that metoprolol succinate ER is likely to be safe for humans?

Research has shown that metoprolol succinate ER is generally safe and well-tolerated. In a six-month study with 60 patients, the medication did not significantly affect their quality of life, indicating it is manageable for most people.

Metoprolol is also a well-known treatment for heart problems and high blood pressure. It has significantly lowered the risk of death compared to a placebo. This safety record makes it a trusted choice for many doctors treating these conditions.

In summary, metoprolol succinate ER has been widely studied and used, and evidence supports its safety for the conditions it is intended to treat. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about metoprolol succinate ER for treating hypertension in African-Americans because it offers a personalized approach to this specific population. While many standard treatments for hypertension, like ACE inhibitors and calcium channel blockers, are widely used, they may not always be as effective in African-American patients due to genetic and physiological differences. Metoprolol succinate ER is a beta-blocker that targets the heart and blood vessels to lower blood pressure, and its extended-release formulation ensures a consistent effect throughout the day. By focusing on how this medication works in African-Americans, researchers hope to optimize treatment and improve outcomes for a group that often experiences higher rates of hypertension.

What evidence suggests that metoprolol succinate ER might be an effective treatment for hypertension in African-Americans?

Research shows that metoprolol succinate, a beta-blocker, can effectively lower blood pressure. Studies have found that this medication reduces the risk of death by 34% compared to a placebo over one year. In a study with 60 patients, it proved safe and well-tolerated, making it a reliable option for treating high blood pressure. This trial will specifically evaluate the effects of metoprolol succinate in African-American participants compared to white participants. However, black patients may respond better to other blood pressure medications like diuretics and calcium channel blockers. This suggests that metoprolol might not be the best choice for everyone, but it still offers promise for many people with high blood pressure. ^{1 2 3 6 7}

Who Is on the Research Team?

Pankaj Arora, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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

Willing to adhere to study drug

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

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

Exclusion Criteria

You currently smoke or have smoked in the past.

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

Your heart beats less than 60 times per minute.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-3-prehypertension-3-2017-ed07c

Beta-Blockers for Hypertension in African-Americans 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2730023/

Ethnic Differences in Cardiovascular Drug Response In comparisons between groups, blacks respond slightly better than whites to diuretics and CCBs, while whites respond slightly better than blacks to ACE ...

3. vivli.org vivli.org/the-efficacy-of-beta-blockers-on-morbidity-and-mortality-endpoints-in-black-hypertensive-patients-a-meta-analysis/

The efficacy of beta-blockers on morbidity and mortality ... The efficacy of beta-blockers on morbidity and mortality endpoints in black hypertensive patients: A meta-analysis · I2 ≤ 25%: low heterogeneity · 25% < I2 < 75%: ...

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/212079

Successful Blood Pressure Control in the African American ... The African American Study of Kidney Disease and Hypertension (AASK) is an ongoing trial to evaluate the effect of blood pressure and choice of ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK532923/

Metoprolol - StatPearls - NCBI Bookshelf [4] The results showed that metoprolol succinate reduced the risk of death by 34% compared with placebo over a mean follow-up of 1 year.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00255528

Dose Ranging, Safety and Tolerability of TOPROL-XL® ... To evaluate the dose range, safety, and tolerability of metoprolol CR/XL in hypertensive pediatric subjects, based on the change in sitting SBP from baseline to ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00255502?term=Metoprolol&viewType=Table&rank=9

307B - Safety, Tolerability and Pharmacokinetics Study of ... The purpose of this trial is to evaluate the pharmacokinetics and long term safety and ; tolerability of metoprolol CR/XL in hypertensive pediatric subjects.