CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes (BRAVO)
Status: Recruiting
Location: See all (2) 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
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
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