RECRUITING
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CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
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.
Conditions:
🦠 End-Stage Kidney Disease 🦠 End-Stage Renal Disease
🗓️ Study Start (Actual) 22 May 2024
🗓️ Primary Completion (Estimated) 3 November 2025
✅ Study Completion (Estimated) 31 December 2027
👥 Enrollment (Estimated) 2540
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Boston, Massachusetts, United States
📍 Minneapolis, Minnesota, United States
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Eligible patients are those (including men, women and minorities)
    • * On hemodialysis
    • * Received one of the following beta blockers through the VA pharmacy prescribed by a VA provider: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol, nadolol, pindolol, nebivolol

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 March 2022
  • First Submitted that Met QC Criteria 26 June 2023
  • First Posted 5 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 May 2024
  • Last Update Posted 28 May 2024
  • Last Verified May 2024
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