RecruitingPhase 3NCT05931276

CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes

CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes (BRAVO)


Sponsor

VA Office of Research and Development

Enrollment

2,540 participants

Start Date

May 22, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • On hemodialysis
  • Received one of the following beta blockers through the VA pharmacy: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol

Exclusion Criteria5

  • 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

Interventions

DRUGMetoprolol Succinate

a dialyzable, beta-1 selective beta blocker

DRUGCarvedilol

a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties


Locations(8)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, United States

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, United States

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, United States

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, United States

View Full Details on ClinicalTrials.gov

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NCT05931276


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