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End-Stage Kidney DiseasePhase 3BRAVONCT05931276

CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes

A Phase 3 study testing Metoprolol Succinate and Carvedilol in people with End-Stage Kidney Disease and End-Stage Renal Disease, run by VA Office of Research and Development at 18 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Metoprolol Succinate and Carvedilol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,540 participants
Where
18 sitesUnited States
Study dates
22 May 2024to 31 Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Christopher M Donnelly contact

Christopher.Donnelly2@va.gov

Jade Fiotto contact

(617) 232-9500

Jade.Fiotto@va.gov

18 sites in 1 country

United States18 sites, 18 recruiting

  • New Mexico VA Health Care System, Albuquerque, NM

    Albuquerque, New Mexico, 87108-5153

    Srihari Raju, MD, Srihari.Raju@va.gov

    Recruiting

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211

    Srihari Raju, MD, srihari.raju@va.gov

    Recruiting

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

    Boston, Massachusetts, 02130-4817

    Jade Fiotto, MPH, 617-232-9500, jade.fiotto@va.gov

    Not yet recruiting

  • Jesse Brown VA Medical Center, Chicago, IL

    Chicago, Illinois, 60612

    Srihari Raju, MD, srihari.raju@va.gov

    Recruiting

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas, 75216-7167

    Peter Van Buren, MD, peter.vanburen@va.gov

    Not yet recruiting

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033-4004

    Sheryl Caberto, MD, sheryl.caberto@va.gov

    Not yet recruiting

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875

    Srihari Raju, MD, srihari.raju@va.gov

    Recruiting

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

    Gainesville, Florida, 32608-1135

    Srihari Raju, MD, Srihari.Raju@va.gov

    Recruiting

  • Iowa City VA Health Care System, Iowa City, IA

    Iowa City, Iowa, 52246-2292

    Srihari Raju, MD, Srihari.Raju@va.gov

    Recruiting

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California, 90822

    Srihari Raju, MD, Srihari.Raju@va.gov

    Recruiting

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417-2309

    Areef Ishani, MD MS, (612) 467-4431 ext. 314431, areef.ishani@va.gov

    Areef Ishani, MD MS

    Recruiting

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

    Omaha, Nebraska, 68105-1850

    Srihari Raju, MD, Srihari.Raju@va.gov

    Recruiting

  • Philadelphia MultiService Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19106

    Srihari Raju, MD, srihari.raju@va.gov

    Recruiting

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240

    Srihari Raju, MD, srihari.raju@va.gov

    Recruiting

  • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

    Salisbury, North Carolina, 28144

    Richard Handler, MD, richard.handler@va.gov

    Not yet recruiting

  • VA Salt Lake City Health Care System, Salt Lake City, UT

    Salt Lake City, Utah, 84148-0001

    Srihari Raju, MD, srihari.raju@va.gov

    Recruiting

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108-1532

    Margaret Fleet, MD, margaret.fleet@va.gov

    Not yet recruiting

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    West Haven, Connecticut, 06516-2770

    Crystal Jobson, MD, crystal.jobson@va.gov

    Not yet recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Metoprolol Succinate, Carvedilol
Keywords
Dialysis, beta-Blockers, Adrenergic, Cardiovascular Diseases, Point of Care Research, Comparative Effectiveness Research, Metoprolol Succinate, Carvedilol, Hemodialysis
Medical subject headings
Kidney Failure, Chronic, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metoprolol SuccinateDrug

    a dialyzable, beta-1 selective beta blocker

  • CarvedilolDrug

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

Study groups in NCT05931276
Study groupRoleWhat they receive
Metoprolol SuccinateActive comparatorDepending on baseline type and dose of beta blocker: * 25 milligrams once daily (12.5 milligrams once daily if > NYHA class II) * 50 milligrams (or 25 milligrams) once daily * 100 milligrams (or 50 milligrams) once daily * 200 milligrams (or 100 milligrams titrated to 200 milligrams) once daily
Receives: Drug: Metoprolol Succinate
CarvedilolActive comparatorDepending on baseline type and dose of beta blocker: * 3.125 milligrams twice daily * 6.25 milligrams twice daily * 12.5 milligrams twice daily * 25 milligrams twice daily (may titrate to 5 0 milligrams twice daily if > 85 kilograms)
Receives: Drug: Carvedilol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

Secondary outcomes (4)

  1. Non-fatal myocardial infarction

    Non-fatal myocardial infarction

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

  2. Non-fatal stroke

    Non-fatal stroke

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

  3. Hospitalization for heart failure

    Hospitalization for heart failure

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

  4. All-cause mortality

    All-cause mortality

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2023
  2. Study start22 May 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study design is a multicenter clinically integrated prospective randomized open-label blinded-endpoint (PROBE) trial
Masking
None (open label)
Enrolment
2,540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05931276
Sponsor's protocol ID
2026
Acronym
BRAVO
Status last verified
Oct 2026
First submitted
29 Mar 2022
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Leatherman SM, Ishani A. Point-of-Care Clinical Trials in Nephrology. J Am Soc Nephrol. 2024 Jun 1;35(6):812-814. doi: 10.1681/ASN.0000000000000340. Epub 2024 Feb 29. No abstract available.

    PubMed 38419159

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metoprolol Succinate and Carvedilol in people with End-Stage Kidney Disease and End-Stage Renal Disease, run by VA Office of Research and Development at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christopher M Donnelly (Christopher.Donnelly2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to major cardiovascular event (time frame: Randomization to time to event; average follow-up 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05931276, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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