CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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
This trial does not accept healthy volunteersQualifiers
On hemodialysis
Received one of the following beta blockers through the VA pharmacy: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Metoprolol Succinate
Druga dialyzable, beta-1 selective beta blocker
Carvedilol
Druga non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties
Treatment groups
2,540 Participants
are divided into 2 treatment groupsGroup A: Metoprolol SuccinateActive comparator 1 intervention
Group B: CarvedilolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to major cardiovascular event
The Primary outcome measure will be time to a non-fatal adverse cardiovascular event, defined as a composite outcome comprised of the first occurrence after randomization of any of the following: myocardial infarction, stroke, or hospitalization for heart failure, and all-cause mortality
Time frame
Randomization to time to event; average follow-up 3 yearsSecondary outcomes
1
Non-fatal myocardial infarction
Non-fatal myocardial infarction
Time frame
Randomization to time to event; average follow-up 3 years2
Non-fatal stroke
Non-fatal stroke
Time frame
Randomization to time to event; average follow-up 3 years3
Hospitalization for heart failure
Hospitalization for heart failure
Time frame
Randomization to time to event; average follow-up 3 years4
All-cause mortality
All-cause mortality
Time frame
Randomization to time to event; average follow-up 3 yearsOther outcomes
1
All-cause hospitalization
All-cause hospitalization
Time frame
Randomization to time to event; average follow-up 3 years2
ED visit or hospitalization possibly related to low BP including falls, fractures, hypotension, or serious injury
Number of emergency department visits or hospitalization for events that may be a consequence of low blood pressure or beta blocker excess or withdrawal including falls, fractures, hypotension, or serious injury
Time frame
Number of events; average follow-up 3 years3
Use of BP raising medications
Use and dose of midodrine
Time frame
Use of drug; average follow-up 3 years4
ED or hospital visits for atrial fibrillation and uncontrolled rate
Emergency department visit or hospitalization for atrial fibrillation with uncontrolled rate (to capture poor control with beta blocker withdrawal)
Time frame
Randomization to time to event; average follow-up 3 yarsSponsors and contacts
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Source ClinicalTrials.gov