CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes

Part of paid clinical trials in Long Beach, California.

Sponsor
VA Office of Research and Development
Study ID
NCT05931276
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • End-Stage Kidney Disease
  • End-Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metoprolol Succinate — DRUG
    a dialyzable, beta-1 selective beta blocker
  • Carvedilol — DRUG
    a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties

Study Details

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.

Key Dates

Start date
May 22, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
2,540 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

Primary Outcome Measure

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

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
VA Long Beach Healthcare System, Long Beach, CALong BeachCalifornia90822
Srihari Raju, MD
[email protected]
North Florida/South Georgia Veterans Health System, Gainesville, FLGainesvilleFlorida32608-1135
Srihari Raju, MD
[email protected]
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033-4004
Srihari Raju, MD
[email protected]
Iowa City VA Health Care System, Iowa City, IAIowa CityIowa52246-2292
Srihari Raju, MD
[email protected]
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABostonMassachusetts02130-4817
Jade Fiotto, MPH
[email protected]
617-232-9500
Minneapolis VA Health Care System, Minneapolis, MNMinneapolisMinnesota55417-2309
Areef Ishani, MD MS
[email protected]
612-467-4431
Areef Ishani, MD MS (STUDY_CHAIR)
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NEOmahaNebraska68105-1850
Srihari Raju, MD
[email protected]
New Mexico VA Health Care System, Albuquerque, NMAlbuquerqueNew Mexico87108-5153
Srihari Raju, MD
[email protected]

Find similar trials in Long Beach, CA

By research site
VA Long Beach Healthcare System, Long Beach, CA· Long Beach, CANorth Florida/South Georgia Veterans Health System, Gainesville, FL· Gainesville, FLAtlanta VA Medical and Rehab Center, Decatur, GA· Decatur, GAIowa City VA Health Care System, Iowa City, IA· Iowa City, IAVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA· Boston, MAMinneapolis VA Health Care System, Minneapolis, MN· Minneapolis, MN

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