Health-Related Quality of Life in the Spironolactone to Reduce ICD Therapy (SPIRIT) Trial

Purpose The Spironolactone to Reduce ICD Therapy (SPIRIT) trial was designed to determine whether once daily spironolactone would: 1) reduce the incidence of ventricular tachycardia (VT) and ventricular fibrillation (VF), and 2) improve health related quality of life (HRQOL) and symptoms. The purpose of this paper is to describe the long term HRQOL outcomes in the SPIRIT trial and compare QOL in those who did or did not receive implantable cardioverter defibrillator (ICD) shocks during follow-up. Methods Ninety participants age 66±10 years, 96% men, 75% with NYHA class II, with an ICD at moderately high risk for recurrent VT/VF were randomized to spironolactone 25mg (N=44) or placebo (N=46). HRQOL was measured every 6 months for 24 months using 3 instruments: Patient Concerns Assessment (PCA), Short Form Health Survey-Veterans Version (SF-36V), and the Kansas City Cardiomyopathy Questionnaire (KCCQ). Linear mixed modeling was used to compare changes in HRQOL across 24-months. ANCOVA was used to compare HRQOL between those getting an ICD shock or not. Results Over 24-months, there were no differences in HRQOL between the spironolactone vs. placebo groups. Those who experienced at least 1 ICD shock vs. those with no ICD shocks, reported significantly lower HRQOL and more symptoms at 6-months and 24 months. Conclusions Spironolactone had no significant impact on HRQOL. Patients receiving one or more ICD shocks reported significant reductions in HRQOL and higher symptoms.