Comparing two beta blockers for heart health in dialysis patients
CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes (BRAVO)
This study is testing which beta blocker, metoprolol or carvedilol, is better for heart health in veterans on dialysis to see if it can help them live longer and feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2540 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 8 sites (Long Beach, California and 7 other locations) |
| Trial ID | NCT05931276 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the cardiovascular outcomes of hemodialysis patients treated with metoprolol succinate, a dialyzable beta blocker, versus carvedilol, a non-dialyzable beta blocker. Approximately 35,000 Veterans with end-stage kidney disease will be involved, as they face high cardiovascular morbidity and mortality rates. The study will utilize a point-of-care randomized controlled trial design to assess which medication leads to better survival rates and overall heart health. Additionally, the trial will explore practices that enhance patient engagement and treatment sustainability.
Who should consider this trial
Good fit: Ideal candidates include hemodialysis patients who are currently receiving beta blockers through the VA pharmacy.
Not a fit: Patients with impaired decision-making capacity or those not receiving carvedilol who have a history of asthma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular outcomes and reduced mortality for dialysis patients.
How similar studies have performed: While there have been observational studies suggesting better outcomes with metoprolol, this is the first head-to-head randomized trial comparing these two beta blockers in end-stage kidney disease patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 this trial is running
Long Beach, California and 7 other locations
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States (Recruiting)
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States (Recruiting)
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (Recruiting)
- Iowa City VA Health Care System, Iowa City, IA — Iowa City, Iowa, United States (Recruiting)
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States (Not_yet_recruiting)
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States (Recruiting)
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha, Nebraska, United States (Recruiting)
- New Mexico VA Health Care System, Albuquerque, NM — Albuquerque, New Mexico, United States (Recruiting)
Study contacts
- Study coordinator: Christopher M Donnelly
- Email: Christopher.Donnelly2@va.gov
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.