CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes (BRAVO)
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• On hemodialysis
• Received one of the following beta blockers through the VA pharmacy: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol
Locations
United States
California
VA Long Beach Healthcare System, Long Beach, CA
RECRUITING
Long Beach
Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL
RECRUITING
Gainesville
Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
RECRUITING
Decatur
Iowa
Iowa City VA Health Care System, Iowa City, IA
RECRUITING
Iowa City
Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
NOT_YET_RECRUITING
Boston
Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
RECRUITING
Minneapolis
Nebraska
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
RECRUITING
Omaha
New Mexico
New Mexico VA Health Care System, Albuquerque, NM
RECRUITING
Albuquerque
Contact Information
Primary
Christopher M Donnelly
Christopher.Donnelly2@va.gov
Backup
Jade Fiotto
Jade.Fiotto@va.gov
(617) 232-9500
Time Frame
Start Date: 2024-05-22
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 2540
Treatments
Active_comparator: Metoprolol Succinate
Depending 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
Active_comparator: Carvedilol
Depending 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)
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development