NCT05931276 · VA Office of Research and Development
CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
(BRAVO)
What this study is about
The investigators aim to determine, using a point-of-care randomly assigned controlled trial design, if hemodialysis patients, who are randomly assigned to metoprolol succinate (a dialyzable, beta-1 selective beta blocker), have an improved cardiovascular outcome compared to those randomly assigned to carvedilol (a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties).
View original scientific description
The investigators aim to determine, using a point-of-care randomized controlled trial design, if hemodialysis patients, who are randomized to metoprolol succinate (a dialyzable, beta-1 selective beta blocker), have an improved cardiovascular outcome compared to those randomized to carvedilol (a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties).
Interventions
DRUG
Metoprolol Succinate
a dialyzable, beta-1 selective beta blocker
DRUG
Carvedilol
a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties
Primary outcome measures
Time to major cardiovascular event
Time frame: Randomization to time to event; average follow-up 3 years
The Primary outcome measure will be time to a non-fatal adverse cardiovascular event, defined as a composite outcome comprised of the first occurrence after randomization of any of the following: myocardial infarction, stroke, or hospitalization for heart failure, and all-cause mortality
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Eligible patients are those (including men, women and minorities)
- On hemodialysis
- Received one of the following beta blockers through the VA pharmacy: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol
Exclusion criteria
- Impaired decision-making capacity
- Patients not receiving carvedilol who have a history of asthma
- known hypersensitivity to any component of either drug
- Provider unwilling to sign a new medication order for a randomized patient
- No surrogate consent will be allowed
Where
- Long Beach, California
- Gainesville, Florida
- Decatur, Georgia
- Iowa City, Iowa
- Boston, Massachusetts
- Minneapolis, Minnesota
- Omaha, Nebraska
- Albuquerque, New Mexico
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 9, 2026 · Source of record for eligibility and locations