NCT05931276 CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
| NCT ID | NCT05931276 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | VA Office of Research and Development |
| Condition | End-Stage Kidney Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,540 participants |
| Start Date | 2024-05-22 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 2,540 participants in total. It began in 2024-05-22 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Christopher M Donnelly
✉ Christopher.Donnelly2@va.govAreef Ishani, MD MS
STUDY CHAIR
Minneapolis VA Health Care System, Minneapolis, MN
Frequently Asked Questions
Who can join the NCT05931276 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying End-Stage Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05931276 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 2,540 participants.
Is NCT05931276 currently recruiting?
Yes, NCT05931276 is actively recruiting participants. Contact the research team at Christopher.Donnelly2@va.gov for enrollment information.
Where is the NCT05931276 trial being conducted?
This trial is being conducted at Long Beach, United States, Gainesville, United States, Decatur, United States, Iowa City, United States and 4 additional locations.
Who is sponsoring the NCT05931276 clinical trial?
NCT05931276 is sponsored by VA Office of Research and Development. The principal investigator is Areef Ishani, MD MS at Minneapolis VA Health Care System, Minneapolis, MN. The trial plans to enroll 2,540 participants.
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