CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
NCT ID: NCT05931276
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2540 participants
INTERVENTIONAL
2024-05-22
2028-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Metoprolol Succinate
a dialyzable, beta-1 selective beta blocker
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)
Carvedilol
a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties
Interventions
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Metoprolol Succinate
a dialyzable, beta-1 selective beta blocker
Carvedilol
a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties
Eligibility Criteria
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Inclusion Criteria
* Received one of the following beta blockers through the VA pharmacy: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Areef Ishani, MD MS
Role: STUDY_CHAIR
Minneapolis VA Health Care System, Minneapolis, MN
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2026
Identifier Type: -
Identifier Source: org_study_id
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