CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metoprolol Succinate, Carvedilol.
- Who it may be relevant to
- Registry conditions: End-Stage Kidney Disease, End-Stage Renal Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes (BRAVO)
Overview
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.
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]
Secondary outcome measures (4)
- Non-fatal myocardial infarction [Time frame: Randomization to time to event; average follow-up 3 years]
- Non-fatal stroke [Time frame: Randomization to time to event; average follow-up 3 years]
- Hospitalization for heart failure [Time frame: Randomization to time to event; average follow-up 3 years]
- All-cause mortality [Time frame: Randomization to time to event; average follow-up 3 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur
- Iowa City VA Health Care System, Iowa City, IA — Iowa City
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha
- New Mexico VA Health Care System, Albuquerque, NM — Albuquerque
Publications
- Leatherman SM, Ishani A. Point-of-Care Clinical Trials in Nephrology. J Am Soc Nephrol. 2024 Jun 1;35(6):812-814. doi: 10.1681/ASN.0000000000000340. Epub 2024 Feb 29. No abstract available. PMID 38419159
Identifiers
NCT: NCT05931276 · 2026