| Trial ID: | L1319 |
| Source ID: | NCT05931276
|
| Associated Drug: |
Metoprolol Succinate
|
| Title: |
CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
|
| Acronym: |
BRAVO
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End-Stage Kidney Disease|End-Stage Renal Disease
|
| Interventions: |
DRUG: Metoprolol Succinate|DRUG: Carvedilol
|
| Outcome Measures: |
Primary: 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: Non-fatal myocardial infarction, Non-fatal myocardial infarction, Randomization to time to event; average follow-up 3 years|Non-fatal stroke, Non-fatal stroke, Randomization to time to event; average follow-up 3 years|Hospitalization for heart failure, Hospitalization for heart failure, Randomization to time to event; average follow-up 3 years|All-cause mortality, All-cause mortality, Randomization to time to event; average follow-up 3 years | Other: All-cause hospitalization, 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 emergency department visits or hospitalization for events that may be a consequence of low blood pressure or beta blocker excess or withdrawal including falls, fractures, hypotension, or serious injury, Number of events; average follow-up 3 years|Use of BP raising medications, Use and dose of midodrine, Use of drug; average follow-up 3 years|ED or hospital visits for atrial fibrillation and uncontrolled rate, Emergency department visit or hospitalization for atrial fibrillation with uncontrolled rate (to capture poor control with beta blocker withdrawal), Randomization to time to event; average follow-up 3 yars
|
| Sponsor/Collaborators: |
Sponsor: VA Office of Research and Development
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
2540
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-05-22
|
| Completion Date: |
2028-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2025-04-10
|
| Locations: |
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|VA NY Harbor Healthcare System, New York, NY, New York, New York, 10010-5011, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05931276
|
