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NCT Number: NCT05931276

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.

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Key information

Conditions

End-stage Kidney Disease Cardiovascular Diseases Chronic Disease Disease Attributes End-stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VA Long Beach Healthcare System, Long Beach, CA, Long Beach, California, United States

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About this study

Approximately 35,000 Veterans have end stage kidney disease (ESKD) with an incidence of 13,000 annually. These numbers are increasing because of the epidemic of diabetes, the most common cause of ESKD, among the Veteran population. Patients with ESKD on hemodialysis have substantial cardiovascular morbidity. Veterans annual mortality is in excess of 15% and more than half the deaths are due to cardiovascular disease. Beta blockers have been shown to prevent cardiovascular events in randomized clinical trials in patients without chronic kidney disease, particularly those with heart failure and after myocardial infarction. Beta blockers are a mainstay of therapy in dialysis patients, with two-thirds of Veterans on dialysis receiving a beta blocker. There are no head-to-head randomized studies comparing the two most commonly used beta blockers in ESKD patients in the United States, metoprolol and carvedilol, but observational studies suggest superior outcomes for patients treated with metoprolol. The identification of the superior beta blocker may significantly improve the morbidity and mortality of the VA dialysis population.

The investigators aim to compare two beta blockers with similar indications, usage and availability within the VA but with major differences in patients dialysis clearance and adrenergic effects. The investigators aim to determine if patients undergoing dialysis have improved survival when using metoprolol succinate, a beta blocker that is removed by dialysis and is beta-1 selective, compared to carvedilol, a beta blocker that is not removed by dialysis and is not beta-selective and is also an alpha-blocker.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Metoprolol succinate

Drug

a dialyzable, beta-1 selective beta blocker

Carvedilol

Drug

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

Primary outcomes

  1. Time to major cardiovascular event

    Time frame: Randomization to time to event; average follow-up 3 years

    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

Secondary outcomes

  1. Non-fatal myocardial infarction

    Time frame: Randomization to time to event; average follow-up 3 years

    Non-fatal myocardial infarction

  2. Non-fatal stroke

    Time frame: Randomization to time to event; average follow-up 3 years

    Non-fatal stroke

  3. Hospitalization for heart failure

    Time frame: Randomization to time to event; average follow-up 3 years

    Hospitalization for heart failure

  4. All-cause mortality

    Time frame: Randomization to time to event; average follow-up 3 years

    All-cause mortality

Other outcomes

  1. All-cause hospitalization

    Time frame: Randomization to time to event; average follow-up 3 years

    All-cause hospitalization

  2. ED visit or hospitalization possibly related to low BP including falls, fractures, hypotension, or serious injury

    Time frame: Number of events; average follow-up 3 years

    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

  3. Use of BP raising medications

    Time frame: Use of drug; average follow-up 3 years

    Use and dose of midodrine

  4. ED or hospital visits for atrial fibrillation and uncontrolled rate

    Time frame: Randomization to time to event; average follow-up 3 yars

    Emergency department visit or hospitalization for atrial fibrillation with uncontrolled rate (to capture poor control with beta blocker withdrawal)

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher M Donnelly

CONTACT

[email protected]

Jade Fiotto

CONTACT

[email protected]

(617) 232-9500

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: BRAVO

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jul 5, 2023
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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