Recruiting
Phase 3

Beta Blocker

Sponsor:

VA Office of Research and Development

Code:

NCT05931276

Conditions

End-Stage Kidney Disease

End-Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Metoprolol Succinate

Carvedilol

Study Details

Brief 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.

Conditions

End-Stage Kidney Disease

End-Stage Renal Disease

Study ID

NCT05931276

Start date

May 22, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2540 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Metoprolol Succinate

Depending on baseline type and dose of beta blocker:

  • 25 mg once daily (12.5 mg once daily if > NYHA class II)
  • 50 mg (or 25 mg) once daily
  • 100 mg (or 50 mg) once daily
  • 200 mg (or 100 mg titrated to 200 mg) once daily

active comparator: Carvedilol

Depending on baseline type and dose of beta blocker:

  • 3.125 mg twice daily
  • 6.25 mg twice daily
  • 12.5 mg twice daily
  • 25 mg twice daily (may titrate to 5 0mg twice daily if > 85 kg)

Interventions

Metoprolol Succinate

a dialyzable, beta-1 selective beta blocker

Carvedilol

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

Primary outcome measure

  • Time to major cardiovascular event [ Time Frame: Randomization to time to event; average follow-up 3 years ]

Central Contacts and Locations

Central contacts

Christopher M Donnelly

Christopher.Donnelly2@va.gov

Jade Fiotto

(617) 232-9500Jade.Fiotto@va.gov

Locations

VA Long Beach Healthcare System, Long Beach, CA

Recruiting

Long Beach, California, United States, 90822

Contacts

Srihari Raju, MD

Srihari.Raju@va.gov

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

Recruiting

Gainesville, Florida, United States, 32608-1135

Contacts

Srihari Raju, MD

Srihari.Raju@va.gov

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Srihari Raju, MD

Srihari.Raju@va.gov

Iowa City VA Health Care System, Iowa City, IA

Recruiting

Iowa City, Iowa, United States, 52246-2292

Contacts

Srihari Raju, MD

Srihari.Raju@va.gov

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Areef Ishani, MD MS

612-467-4431areef.ishani@va.gov

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

Recruiting

Omaha, Nebraska, United States, 68105-1850

Contacts

Srihari Raju, MD

Srihari.Raju@va.gov

New Mexico VA Health Care System, Albuquerque, NM

Recruiting

Albuquerque, New Mexico, United States, 87108-5153

Contacts

Srihari Raju, MD

Srihari.Raju@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

  • Dialysis
  • beta-Blockers, Adrenergic
  • Cardiovascular Diseases
  • Point of Care Research
  • Comparative Effectiveness Research
  • Metoprolol Succinate
  • Carvedilol
  • Hemodialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-09.