CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
BRAVO
1 other identifier
interventional
2,540
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2024
Longer than P75 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2022
CompletedFirst Posted
Study publicly available on registry
July 5, 2023
CompletedStudy Start
First participant enrolled
May 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
January 9, 2026
January 1, 2026
2.6 years
March 29, 2022
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to major cardiovascular event
The Primary outcome measure will be time to a non-fatal adverse cardiovascular event, defined as a composite outcome comprised of the first occurrence after randomization of any of the following: myocardial infarction, stroke, or hospitalization for heart failure, and all-cause mortality
Randomization to time to event; average follow-up 3 years
Secondary Outcomes (4)
Non-fatal myocardial infarction
Randomization to time to event; average follow-up 3 years
Non-fatal stroke
Randomization to time to event; average follow-up 3 years
Hospitalization for heart failure
Randomization to time to event; average follow-up 3 years
All-cause mortality
Randomization to time to event; average follow-up 3 years
Other Outcomes (4)
All-cause hospitalization
Randomization to time to event; average follow-up 3 years
ED visit or hospitalization possibly related to low BP including falls, fractures, hypotension, or serious injury
Number of events; average follow-up 3 years
Use of BP raising medications
Use of drug; average follow-up 3 years
- +1 more other outcomes
Study Arms (2)
Metoprolol Succinate
ACTIVE COMPARATORDepending on baseline type and dose of beta blocker: * 25 mg once daily (12.5 mg once daily if \> NYHA class II) * 50 mg (or 25 mg) once daily * 100 mg (or 50 mg) once daily * 200 mg (or 100 mg titrated to 200 mg) once daily
Carvedilol
ACTIVE COMPARATORDepending on baseline type and dose of beta blocker: * 3.125 mg twice daily * 6.25 mg twice daily * 12.5 mg twice daily * 25 mg twice daily (may titrate to 5 0mg twice daily if \> 85 kg)
Interventions
a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties
Eligibility Criteria
You may qualify if:
- On hemodialysis
- Received one of the following beta blockers through the VA pharmacy: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822, United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135, United States
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004, United States
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2292, United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817, United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309, United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850, United States
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153, United States
Related Publications (1)
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: 38419159DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Areef Ishani, MD MS
Minneapolis VA Health Care System, Minneapolis, MN
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2022
First Posted
July 5, 2023
Study Start
May 22, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share