Phase 4
Completed N=90
Antiarrhythmic Effects of Spironolactone in Patients With ICDs
Source: ClinicalTrials.gov NCT04495712 ↗Enrolled (actual)
90
Serious AEs
84.4%
Results posted
Sep 2020
Primary outcomePrimary: Time to First Appropriate Implantable Cardioverter Defibrillator (ICD) Therapy — 8.8; 12.3 months — p=0.71
◆ Published Evidence
Emerging
19citations · ~1 / year
The effect of spironolactone on ventricular tachyarrhythmias in patients with implantable cardioverter-defibrillators.
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.
Linked Publications (2)
-
The effect of spironolactone on ventricular tachyarrhythmias in patients with implantable cardioverter-defibrillators.
-
Health-Related Quality of Life in the <u>Spi</u>ronolactone to <u>R</u>educe <u>I</u>CD <u>T</u>herapy (SPIRIT) Trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.