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Beta Blocker

Beta-Blockers for Hypertension in African-Americans

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up about 3 hours on the exercise challenge visit day after consuming study meals for 3 days

Awards & highlights

Study Summary

This trial is studying how well different beta-blockers work in African-Americans.

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.Check my eligibility

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.See study design

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

Select...

I am between 18 and 40 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ about 3 hours on the exercise challenge visit day after consuming study meals for 3 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~about 3 hours on the exercise challenge visit day after consuming study meals for 3 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and about 3 hours on the exercise challenge visit day after consuming study meals for 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in plasma BNP after Exercise

Change in plasma NTproBNP after 6-weeks of beta-blocker

Secondary outcome measures

Change in plasma BNP, NTproANP and MRproANP

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: African-AmericanExperimental 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: Caucasians (White)Active 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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,833 Previous Clinical Trials

47,306,416 Total Patients Enrolled

470 Trials studying Hypertension

2,151,706 Patients Enrolled for Hypertension

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,277,949 Total Patients Enrolled

43 Trials studying Hypertension

90,679 Patients Enrolled for Hypertension

Pankaj Arora, MDPrincipal Investigator - University of Alabama at Birmingham

University of Alabama at Birmingham

2 Previous Clinical Trials

123 Total Patients Enrolled

Media Library

Metoprolol Succinate ER (Beta Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT03070184 — Phase 2

Hypertension Research Study Groups: African-American, Caucasians (White)

Hypertension Clinical Trial 2023: Metoprolol Succinate ER Highlights & Side Effects. Trial Name: NCT03070184 — Phase 2

Metoprolol Succinate ER (Beta Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03070184 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this investigation currently on-going?

"Affirmative. The available data on clinicaltrials.gov demonstrates that this study is actively recruiting, having been first posted on April 30th 2017 and last modified November 7th 2022. 80 participants are sought from a single site to participate in the trial."

Answered by AI

What are the criteria to be eligible for enrollment in this trial?

"80 participants, aged 18 to 40 and with prehypertension, will be admitted into this clinical trial. Additionally, those chosen must possess the capability of completing an exercise capacity test as well as a Body Mass Index between 18-25 kg/m2."

Answered by AI

Has there been prior research on measuring Exercise capacity VO2 max?

"Presently, 21 clinical trials concerning Exercise capacity VO2 max determination are in operation with 4 of those at the final stage. While Orlando is the hub for research on this treatment, there are 144 sites running such studies globally."

Answered by AI

Does this research encompass individuals aged eighty-five and above?

"Taking the inclusion criteria into account, this clinical trial has a floor of 18 years old and an upper limit of 40."

Answered by AI

To what end is Exercise capacity VO2 max determination most often employed?

"Exercise capacity VO2 max determination is the preferred method of treatment for hemodynamically stable patients. It has also proven to be a viable intervention strategy for angina pectoris, atrial fibrillation, and hypertensive disease."

Answered by AI

What risks do patients face when undergoing Exercise capacity VO2 max determination?

"Our team at Power assigned a score of 2 to the safety profile of Exercise capacity VO2 max determination, as this trial is still in its second phase and only provides evidence for safety but not efficacy."

Answered by AI

What is the overall participation size of this experiment?

"Affirmative. Clinicaltrials.gov verifies that this research trial is actively seeking participants, which was first posted on April 30th 2017 and most recently updated in November 7th 2022. 80 subjects are being sought from a single medical centre."

Answered by AI

Recent research and studies

American Journal of Physiology-Endocrinology and MetabolismJournal

Maximal Aerobic Capacity in African-american and Caucasian Prepubertal Children

Trowbridge, Christina A., Barbara A. Gower, Tim R. Nagy, Gary R. Hunter, Margarita S. Treuth, and Michael I. Goran. 1997. “Maximal Aerobic Capacity in African-american and Caucasian Prepubertal Children”. American Journal of Physiology-endocrinology and Metabolism. American Physiological Society. doi:10.1152/ajpendo.1997.273.4.e809.

European Journal of Clinical InvestigationJournal

Responses of Atrial Natriuretic Peptide and Brain Natriuretic Peptide to Exercise in Patients with Chronic Heart Failure and Normal Control Subjects

STEELE, I. C., G. McDOWELL, A. MOORE, N. P. S. CAMPBELL, C. SHAW, K. D. BUCHANAN, and D. P. NICHOLLS. 1997. “Responses of Atrial Natriuretic Peptide and Brain Natriuretic Peptide to Exercise in Patients with Chronic Heart Failure and Normal Control Subjects”. European Journal of Clinical Investigation. Wiley. doi:10.1046/j.1365-2362.1997.1070653.x.

CirculationJournal

Introduction of Metoprolol Increases Plasma B-type Cardiac Natriuretic Peptides in Mild, Stable Heart Failure

Davis, Mark E., A. Mark Richards, M. Gary Nicholls, Timothy G. Yandle, Christopher M. Frampton, and Richard W. Troughton. 2006. “Introduction of Metoprolol Increases Plasma B-type Cardiac Natriuretic Peptides in Mild, Stable Heart Failure”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.105.567727.

Medicine & Science in Sports & ExerciseJournal