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Beta Blocker
Beta Blockers for Kidney Failure (BRAVO Trial)
Phase 3
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up use of drug; average follow-up 3 years
Awards & highlights
BRAVO 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.Check my eligibility
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.See study design
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.
BRAVO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently on hemodialysis.
Select...
I am taking a beta blocker prescribed by the VA.
BRAVO Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to major cardiovascular event
Secondary outcome measures
All-cause mortality
Hospitalization for heart failure
Non-fatal myocardial infarction
+1 moreOther outcome measures
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 moreBRAVO 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
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,304,063 Total Patients Enrolled
James S Kaufman, MDStudy ChairManhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Areef Ishani, MD MSStudy ChairMinneapolis VA Health Care System, Minneapolis, MN
1 Previous Clinical Trials
13,523 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have difficulty making decisions due to my health condition.I have asthma and am not taking carvedilol.My doctor is not willing to sign for a new medication if I am selected.You are allergic to any part of the drugs.I am currently on hemodialysis.I am taking a beta blocker prescribed by the VA.
Research Study Groups:
This trial has the following groups:- Group 1: Carvedilol
- Group 2: Metoprolol Succinate
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any potential dangers associated with taking Metoprolol Succinate?
"Our team at Power has rated Metoprolol Succinate's safety as a 3, due to the number of clinical trials that have proven its efficacy and numerous studies affirming its security."
Answered by AI
Is this medical trial in the process of enrolling participants?
"According to clinicaltrials.gov, this particular medical trial has ceased enrolling patients as of June 26th 2023. While the 623 other trials are still looking for participants, this specific trial is no longer a viable option."
Answered by AI
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