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Study: Long-Term Spironolactone Does Not Improve Heart Failure Symptoms

No significant change in exercise capacity or quality of life versus placebo (Feb. 27)

Researchers have found that long-term treatment with spironolactone (Aldactone, Pfizer) improved left ventricular diastolic function but did not affect maximal exercise capacity, patient symptoms, or quality of life (QOL) in patients with heart failure (HF) with preserved left ventricular ejection fraction (LVEF). The new findings were published Feb. 27 in the online edition of JAMA.

According to the article, HF with preserved LVEF accounts for more than 50% of the total HF population. LVEF is the percentage of blood that is pumped out of a filled ventricle as a result of a heartbeat. There is no established therapy for this condition, and stimulation with the hormone aldosterone may contribute to its progression.

Frank Edelmann, MD, and his colleagues conducted a study to examine the long-term effects of spironolactone, an aldosterone receptor blocker, on diastolic function and exercise capacity in patients with HF with preserved LVEF. The Aldo-DHF trial — a randomized, placebo-controlled study — was conducted between March 2007 and April 2012 in Germany and Austria. The study included 422 patients (average age, 67 years) with chronic New York Heart Association class II or III heart failure, preserved LVEF of 50% or greater, and evidence of diastolic dysfunction. The patients were randomly assigned to receive 25 mg of spironolactone once daily (n = 213) or matching placebo (n = 209) with 12 months of follow-up. The primary outcome measures were changes in diastolic function on echocardiography and maximal exercise capacity (peak VO2) on cardiopulmonary exercise testing.

The researchers found that although long-term treatment with spironolactone improved some measures, such as left ventricular end-diastolic filling, left ventricular remodeling, and neurohumoral activation, maximal exercise capacity did not significantly change compared with placebo therapy. Moreover, spironolactone did not improve heart failure symptoms or QOL, and the drug only slightly reduced the 6-minute walking distance.

The authors called for additional studies to evaluate further the effect of improving diastolic function on symptomatic, functional, and clinical endpoints.

Sources: JAMA Abstract; February 27, 2013; and JAMA News; February 26, 2013.

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