Point-of-Care Clinical Trials in Nephrology.
Sarah M Leatherman, Areef Ishani
https://pubmed.ncbi.nlm.nih.gov/38419159Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID05931276
CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes (BRAVO)
Led by VA Office of Research and Development · Updated on 2026-01-09
2540
Participants Needed
8
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two types of beta blockers, metoprolol succinate and carvedilol, in patients with end-stage kidney disease (ESKD) who are on hemodialysis. This study aims to find out if metoprolol succinate, which is dialyzable and beta-1 selective, leads to better cardiovascular outcomes compared to carvedilol, which is non-dialyzable, non-selective, and also blocks alpha-1 receptors. The study addresses the high cardiovascular risks faced by veterans with ESKD and seeks to improve survival and reduce heart-related complications. Participants will be randomly assigned to receive either metoprolol succinate or carvedilol. Dosing depends on the type and baseline dose of beta blocker previously used, with metoprolol succinate given once daily in doses ranging from 12.5 mg to 200 mg, and carvedilol given twice daily in doses from 3.125 mg to 50 mg depending on weight. The study will compare these treatments over an average follow-up period of three years. During the study, researchers will monitor participants for major cardiovascular events, such as heart attacks, strokes, hospitalizations for heart failure, and overall survival. The time from randomization to these events will be tracked. Care is taken to ensure treatment orders are updated and participants continue receiving their assigned medication through the VA pharmacy. The study enrollment started in May 2024, and participants will be followed for about three years to assess outcomes and safety.
CONDITIONS
Brief Title
CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- On hemodialysis
- Received one of the following beta blockers through the VA pharmacy: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, or bisoprolol
- Adults aged 18 years or older
You will not qualify if you...
- 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 allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Average follow-up 3 years
Participants receive one of two beta blockers to compare their effects on cardiovascular outcomes while undergoing hemodialysis.
Visits according to medication management and follow-up schedule
Trial Site Locations
Total: 8 locations
1
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
Actively Recruiting
2
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608-1135
Actively Recruiting
3
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004
Actively Recruiting
4
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States, 52246-2292
Actively Recruiting
5
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817
Not Yet Recruiting
6
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417-2309
Actively Recruiting
7
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States, 68105-1850
Actively Recruiting
8
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, United States, 87108-5153
Actively Recruiting
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Research Team
C
Christopher M Donnelly
J
Jade Fiotto
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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