Phase 4
N=90
Antiarrhythmic Effects of Spironolactone in Patients With ICDs
Ventricular Arrhythmias
Bottom Line
View on ClinicalTrials.gov: NCT04495712 ↗Enrolled (actual)
90
Serious AEs
84.4%
Results posted
Sep 2020
Primary outcome: Primary: Time to First Appropriate Implantable Cardioverter Defibrillator (ICD) Therapy — 8.8; 12.3 months — p=0.71
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- spironolactone (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Appropriate Implantable Cardioverter Defibrillator (ICD) Therapy |
8.8; 12.3 | 0.71 |
| SECONDARY All Cause Hospitalization |
28; 24 | 0.07 |
| SECONDARY Ventricular Refractoriness |
294.2; 278.3 | 0.42 |
| SECONDARY Short Form Health Survey Adapted for Veterans (SF36V) |
54.87; 63.31 | — |
| SECONDARY Patient Concerns Assessment (PCA) |
22.15; 18.42 | — |
| SECONDARY Kansas City Cardiomyopathy Questionnaire (KCCQ) |
57.35; 68.67 | — |
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.
Eligibility 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 2.5 mg/dL,
- a serum potassium concentration of >5.0 mmol/L, and
- a life expectancy of <2 years.
Data sourced from ClinicalTrials.gov (NCT04495712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.