Abstract
To evaluate the effects of an aldosterone antagonist on exercise intolerance in older adults with heart failure and preserved ejection fraction (HFpEF). Randomized, placebo-controlled, double-blind trial. Academic medical center, Winston-Salem, North Carolina. Older adults (N=80, aged 71±1; 80% female) with stable compensated HFpEF and controlled blood pressure (BP). Participants were randomized into a 9-month treatment of spironolactone 25mg/d vs placebo. Assessments were peak exercise oxygen consumption (VO2 ), 6-minute walk test, Minnesota Living with Heart Failure Questionnaire (MLHFQ), cardiac magnetic resonance imaging, Doppler echocardiography, and vascular ultrasound. Seventy-one participants completed the trial: 37 in the spironolactone group and 34 in the placebo group. Adherence according to pill count was excellent (spironolactone 95%, placebo 97%). Mean spironolactone dose was 24.3±2.9mg/d and was well tolerated. Spironolactone significantly reduced systolic and diastolic BP at rest and peak exercise. At 9-month follow-up, baseline-adjusted peak VO2, the primary outcome, was 13.5±0.3mL/kg per minute in the spironolactone group versus 13.9±0.3mL/kg per minute in the placebo group (adjusted mean difference-0.4mL/kg per minute; 95% confidence interval=-1.1-0.4mL/kg per minute; P=.38). The 95% confidence intervals of spironolactone's effect on peak VO2 (-8.2% to 3.2%) excluded a clinically significant beneficial effect. There were also no significant differences in 6-minute walk distance, arterial stiffness, left ventricular (LV) mass, LV mass/end-diastolic volume, or MLHFQ score. In older adults with stable compensated HFpEF, 9 months of spironolactone 25mg/d was well tolerated and reduced BP but did not improve exercise capacity, quality of life, LV mass, or arterial stiffness.
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