Antiarrhythmic Effects of Spironolactone in Patients With ICDs

Completed · Phase 4 · Has a placebo group

Conditions studied: Ventricular Arrhythmias

In brief

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.

Key facts

Study ID

NCT04495712

Run by

VA Office of Research and Development

People needed

90

Starts

2004-07-28

Expected to finish

2008-05-28

Last updated by the study team

2020-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients were considered eligible for enrollment only if they had received
• an ICD therapy, either a shock or antitachycardia pacing (ATP),
• VT/VF in the previous 2 years or
• received an ICD for secondary prevention of sustained VT/VF in the previous 6 months.

You may not qualify if…

• Important exclusion criteria were
• an indication for spironolactone based on the RALES trial (EF of <35% and -New York Heart Association (NYHA) class III or IV),
• unstable angina,
• primary hepatic failure,
• known intolerance to spironolactone,
• a serum creatinine concentration of >2.5 mg/dL,
• a serum potassium concentration of >5.0 mmol/L, and
• a life expectancy of <2 years.

Where it is running

• VA Portland Health Care System, Portland, OR — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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