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CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes

Study acronym: BRAVO
StatusRecruiting
PhasePhase 3
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Trial sites expanded: 8 → 18 locations
    • Eligibility criteria expanded, about 7 words
    • Publications: details revised at 1 of 1 entry
  2. Minor Study sites: 2 to 8v12
  3. Minor Study sites: 3 to 2
    • Eligibility criteria shortened, about 9 words
    v11
  4. Notable Primary completion date: Nov 3, 2025 to Dec 31, 2026
    • Study completion date: Dec 31, 2027 to Dec 31, 2028
    • Eligibility criteria shortened, about 5 words
    v10
  5. Minor Eligibility criteria shortened, about 3 wordsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 5 to 3
    • Start date changed from estimate of Jun 14, 2024 to May 22, 2024
    v8
  2. Notable Start date: May 15, 2024 to Jun 14, 2024
    • Study sites revised (5)
    v7
  3. Notable Start date: Apr 1, 2024 to May 15, 2024v6
  4. Notable Start date: Feb 1, 2024 to Apr 1, 2024v5
  5. Notable Start date: Jan 1, 2024 to Feb 1, 2024v4
  6. Notable Start date: Oct 2, 2023 to Jan 1, 2024v3
  7. Notable Primary completion date: Nov 4, 2024 to Nov 3, 2025
    • Start date: Sep 4, 2023 to Oct 2, 2023
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05931276
Lead Sponsor VA Office of Research and Development
Conditions
(from sponsor)
End-Stage Kidney Disease, End-Stage Renal Disease
Related terms Cardiovascular Diseases, Kidney Failure, Chronic
Enrollment 2,540 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov