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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05931276
Other study ID # 2026
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 22, 2024
Est. completion date December 31, 2027

Study information

Verified date May 2024
Source VA Office of Research and Development
Contact Jade Fiotto
Phone (617) 232-9500
Email Jade.Fiotto@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Approximately 35,000 Veterans have end stage kidney disease (ESKD) with an incidence of 13,000 annually. These numbers are increasing because of the epidemic of diabetes, the most common cause of ESKD, among the Veteran population. Patients with ESKD on hemodialysis have substantial cardiovascular morbidity. Veterans annual mortality is in excess of 15% and more than half the deaths are due to cardiovascular disease. Beta blockers have been shown to prevent cardiovascular events in randomized clinical trials in patients without chronic kidney disease, particularly those with heart failure and after myocardial infarction. Beta blockers are a mainstay of therapy in dialysis patients, with two-thirds of Veterans on dialysis receiving a beta blocker. There are no head-to-head randomized studies comparing the two most commonly used beta blockers in ESKD patients in the United States, metoprolol and carvedilol, but observational studies suggest superior outcomes for patients treated with metoprolol. The identification of the superior beta blocker may significantly improve the morbidity and mortality of the VA dialysis population. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2540
Est. completion date December 31, 2027
Est. primary completion date November 3, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Eligible patients are those (including men, women and minorities) - On hemodialysis - Received one of the following beta blockers through the VA pharmacy prescribed by a VA provider: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol, nadolol, pindolol, nebivolol 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

Study Design


Intervention

Drug:
Metoprolol Succinate
a dialyzable, beta-1 selective beta blocker
Carvedilol
a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties

Locations

Country Name City State
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 VA NY Harbor Healthcare System, New York, NY New York New York

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other All-cause hospitalization All-cause hospitalization Randomization to time to event; average follow-up 3 years
Other 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 Number of events; average follow-up 3 years
Other Use of BP raising medications Use and dose of midodrine Use of drug; average follow-up 3 years
Other 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) Randomization to time to event; average follow-up 3 yars
Primary 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 Randomization to time to event; average follow-up 3 years
Secondary Non-fatal myocardial infarction Non-fatal myocardial infarction Randomization to time to event; average follow-up 3 years
Secondary Non-fatal stroke Non-fatal stroke Randomization to time to event; average follow-up 3 years
Secondary Hospitalization for heart failure Hospitalization for heart failure Randomization to time to event; average follow-up 3 years
Secondary All-cause mortality All-cause mortality Randomization to time to event; average follow-up 3 years
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