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Beta Blocker

Beta Blockers for Kidney Failure (BRAVO Trial)

Phase 3

Recruiting

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Eligible patients are those (including men, women and minorities) on hemodialysis

Received one of the following beta blockers through the VA pharmacy prescribed by a VA provider: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol, nadolol, pindolol, nebivolol

Must not have

Impaired decision-making capacity

Patients not receiving carvedilol who have a history of asthma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up use of drug; average follow-up 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare two medications to see if one is better at improving heart health for hemodialysis patients. Researchers also look at ways to get patients to use the medication.

Who is the study for?

This trial is for hemodialysis patients with kidney disease who are already taking certain beta blockers (like metoprolol or carvedilol) prescribed by a VA provider. It's open to men, women, and minorities. Those not eligible include patients whose providers won't consent to medication changes, those without decision-making capacity, asthma patients not on carvedilol, or anyone allergic to the drugs being tested.

What is being tested?

The study compares two heart medications in dialysis patients: Metoprolol Succinate (which can be removed during dialysis) versus Carvedilol (which cannot). The goal is to see which drug leads to better heart health outcomes. Patients will be randomly assigned one of these drugs in this controlled trial.

What are the potential side effects?

Possible side effects from both Metoprolol Succinate and Carvedilol may include dizziness, fatigue, low blood pressure, slower heart rate, and digestive issues. Each patient's experience with side effects might vary.

Eligibility Criteria

Inclusion Criteria

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

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I am currently on hemodialysis.

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I am taking a beta blocker prescribed by the VA.

Exclusion Criteria

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

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I have difficulty making decisions due to my health condition.

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I have asthma and am not taking carvedilol.

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My doctor is not willing to sign for a new medication if I am selected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ use of drug; average follow-up 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~use of drug; average follow-up 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and use of drug; average follow-up 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Time to major cardiovascular event

Secondary study objectives

All-cause mortality

Hospitalization for heart failure

Non-fatal myocardial infarction

+1 more

Other study objectives

All-cause hospitalization

ED or hospital visits for atrial fibrillation and uncontrolled rate

ED visit or hospitalization possibly related to low BP including falls, fractures, hypotension, or serious injury

+1 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Group I: CarvedilolActive Control1 Intervention

Depending on baseline type and dose of beta blocker: * 3.125 mg twice daily * 6.25 mg twice daily * 12.5 mg twice daily * 25 mg twice daily (may titrate to 5 0mg twice daily if \> 85 kg)

Group II: Metoprolol SuccinateActive Control1 Intervention

Depending on baseline type and dose of beta blocker: * 25 mg once daily (12.5 mg once daily if \> NYHA class II) * 50 mg (or 25 mg) once daily * 100 mg (or 50 mg) once daily * 200 mg (or 100 mg titrated to 200 mg) once daily

0 / 5Eligibility criteria met