Antiarrhythmic Effects of Spironolactone in Patients With ICDs

• Status: Completed
• Trial end date: 2008-05-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

-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.

Exclusion Criteria:

-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.