Point-of-Care Clinical Trials in Nephrology.
Sarah M Leatherman, Areef Ishani
https://pubmed.ncbi.nlm.nih.gov/38419159/Actively Recruiting
Led by VA Office of Research and Development · Updated on 2026-01-09
2540
Participants Needed
8
Research Sites
104 weeks
Total Duration
Researchers are evaluating two types of beta blockers, metoprolol succinate and carvedilol, in patients with end-stage kidney disease ESKD who are on hemodialysis. This study aims to find out if metoprolol succinate, which is dialyzable and beta-1 selective, leads to better cardiovascular outcomes compared to carvedilol, which is non-dialyzable, non-selective, and also blocks alpha-1 receptors. The study addresses the high cardiovascular risks faced by veterans with ESKD and seeks to improve survival and reduce heart-related complications. Participants will be randomly assigned to receive either metoprolol succinate or carvedilol. Dosing depends on the type and baseline dose of beta blocker previously used, with metoprolol succinate given once daily in doses ranging from 12.5 mg to 200 mg, and carvedilol given twice daily in doses from 3.125 mg to 50 mg depending on weight. The study will compare these treatments over an average follow-up period of three years. During the study, researchers will monitor participants for major cardiovascular events, such as heart attacks, strokes, hospitalizations for heart failure, and overall survival. The time from randomization to these events will be tracked. Care is taken to ensure treatment orders are updated and participants continue receiving their assigned medication through the VA pharmacy. The study enrollment started in May 2024, and participants will be followed for about three years to assess outcomes and safety.
CONDITIONS
CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
C
Christopher M Donnelly
J
Jade Fiotto
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VA Office of Research and Development
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Metoprolol succinate | Carvedilol | Non‑dialyzable beta‑blocker use (observational) |
|---|---|---|---|
| What it is | A dialyzable, beta‑1 selective beta‑blocker arm in the randomized trial | A non‑dialyzable, non‑selective beta‑blocker with alpha‑1 antagonist properties arm in the trial | Non‑dialyzable beta‑blockers are widely used across dialysis care; observational data suggest differences in outcomes compared with dialyzable agents |
| Role in the trial | Assigned randomized treatment arm | Assigned randomized comparator arm | Represents common current beta‑blocker practice outside the trial |
| Primary use | Used to prevent cardiovascular events in hemodialysis patients | Used to prevent cardiovascular events in hemodialysis patients | Beta‑blockers are used to reduce cardiovascular risk in dialysis patients |
| How it is given or performed | Oral metoprolol succinate administered per VA point‑of‑care randomization | Oral carvedilol administered per VA point‑of‑care randomization | Administered per usual clinical prescribing practices outside a trial |
| Evidence status | Randomized evidence pending; no direct comparative outcomes yet | Randomized evidence pending; no direct comparative outcomes yet | Observational data suggest higher mortality with non‑dialyzable compared to dialyzable beta‑blockers in dialysis populations |
| Important risks | Safety profile within trial not yet reported | Safety profile within trial not yet reported | Observational studies suggest non‑dialyzable beta‑blockers may be associated with intradialytic hypotension and higher mortality |
| Important limitations | Results not yet available | Results not yet available | Observational findings may be biased by confounding and do not establish causality |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Average follow-up 3 years
Participants receive one of two beta blockers to compare their effects on cardiovascular outcomes while undergoing hemodialysis.
Visits according to medication management and follow-up schedule
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Sarah M Leatherman, Areef Ishani
https://pubmed.ncbi.nlm.nih.gov/38419159/VA Office of Research and Development
Lead Sponsor