Status:
COMPLETED
Antiarrhythmic Effects of Spironolactone in Patients With ICDs
Lead Sponsor:
VA Office of Research and Development
Conditions:
Ventricular Arrhythmias
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 patien...
Detailed Description
Objectives: This study is designed to determine whether spironolactone at a dose of 25 mg per day in patients with implanted cardioverter defibrillators (ICD) will 1) Reduce the incidence of ventricul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 28 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2008
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04495712
Start Date
July 28 2004
End Date
May 28 2008
Last Update
October 9 2020
Active Locations (1)
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1
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239