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Antiarrhythmic Effects of Spironolactone in Patients With ICDs

NCT04495712 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-10-09

Study results available
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Summary

This study will test whether spironolactone, an approved drug for among other things hypertension, will reduce the risk of severe arrhythmias in patients with implanted defibrillators. Half the patients in the study will get spironolactone and half will get a placebo. Neither the patients or their providers will know if they are getting spironolactone or placebo.

Conditions

  • Ventricular Arrhythmias

Interventions

DRUG

spironolactone

aldosterone blocker

DRUG

placebo

identical in appearance to spironolactone study drug

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Merritt Raitt, MD · VA Portland Health Care System, Portland, OR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-28
Primary Completion
2008-05-28
Completion
2008-05-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04495712 on ClinicalTrials.gov