NCT05931276

CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,540 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 randomized clinical trials in patients without chronic kidney disease, particularly those with heart failure and after myocardial infarction. Beta blockers are a mainstay of therapy in dialysis patients, with two-thirds of Veterans on dialysis receiving a beta blocker. There are no head-to-head randomized studies comparing the two most commonly used beta blockers in ESKD patients in the United States, metoprolol and carvedilol, but observational studies suggest superior outcomes for patients treated with metoprolol. The identification of the superior beta blocker may significantly improve the morbidity and mortality of the VA dialysis population. The investigators aim to compare two beta blockers with similar indications, usage and availability within the VA but with major differences in patients dialysis clearance and adrenergic effects. The investigators aim to determine if patients undergoing dialysis have improved survival when using metoprolol succinate, a beta blocker that is removed by dialysis and is beta-1 selective, compared to carvedilol, a beta blocker that is not removed by dialysis and is not beta-selective and is also an alpha-blocker.

Conditions

• End-Stage Kidney Disease
• End-Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Metoprolol Succinate	a dialyzable, beta-1 selective beta blocker
DRUG	Carvedilol	a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties

Timeline

• Start date: 2024-05-22
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2023-07-05
• Last updated: 2026-01-09

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study