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CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes (BRAVO)


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). The investigators will also examine intervention practices to identify components that best support engagement and sustainability.Approximately 35,000 Veterans have end stage kidney disease (ESKD) with an incidence of 13,000 annually. These numbers are increasing because of the epidemic of diabetes, the most common cause of ESKD, among the Veteran population. Patients with ESKD on hemodialysis have substantial cardiovascular morbidity. Veterans annual mortality is in excess of 15% and more than half the deaths are due to cardiovascular disease. Beta blockers have been shown to prevent cardiovascular events in randomi

Trial Eligibility

Inclusion Criteria: * 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 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

Study Info

Organization

VA Office of Research and Development


Primary Outcome

Time to major cardiovascular event


Outcome Timeframe Randomization to time to event; average follow-up 3 years

NCTID NCT05931276

Phases PHASE3

Primary Purpose TREATMENT

Start Date 2024-05-22

Completion Date 2025-11-03

Enrollment Target 2540

Interventions

DRUG Metoprolol Succinate

DRUG Carvedilol

Locations Recruiting

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

United States, Massachusetts, Boston


Minneapolis VA Health Care System, Minneapolis, MN

United States, Minnesota, Minneapolis


VA NY Harbor Healthcare System, New York, NY

United States, New York, New York


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