Testosterone therapy in men with moderate severity heart failure: a double-blind randomized placebo controlled trial

Randomized Controlled Trial

doi: 10.1093/eurheartj/ehi443. Epub 2005 Aug 10.

Affiliations

PMID: 16093267
DOI: 10.1093/eurheartj/ehi443

Randomized Controlled Trial

Chris J Malkin et al. Eur Heart J. 2006 Jan.

Abstract

Aims: Chronic heart failure is associated with maladaptive and prolonged neurohormonal and pro-inflammatory cytokine activation causing a metabolic shift favouring catabolism, vasodilator incapacity, and loss of skeletal muscle bulk and function. In men, androgens are important determinants of anabolic function and physical strength and also possess anti-inflammatory and vasodilatory properties.

Methods and results: We conducted a randomized, double-blind, placebo-controlled parallel trial of testosterone replacement therapy (5 mg Androderm) at physiological doses in 76 men (mean+/-SD, age 64+/-9.9) with heart failure (ejection fraction 32.5+/-11%) over a maximum follow-up period of 12 months. The primary endpoint was functional capacity as assessed by the incremental shuttle walk test (ISWT). At baseline, 18 (24%) had serum testosterone below the normal range and bioavailable testosterone correlated with distance walked on the initial ISWT (r=0.3, P=0.01). Exercise capacity significantly improved with testosterone therapy compared with placebo over the full study period (mean change +25+/-15 m) corresponding to a 15+/-11% improvement from baseline (P=0.006 ANOVA). Symptoms improved by at least one functional class on testosterone in 13 (35%) vs. 3 (8%) on placebo (P=0.01). No significant changes were found in handgrip strength, skeletal muscle bulk by cross-sectional computed tomography, or in tumour necrosis factor levels. Testosterone therapy was safe with no excess of adverse events although the patch preparation was not well tolerated by the study patients.

Conclusion: Testosterone replacement therapy improves functional capacity and symptoms in men with moderately severe heart failure.

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Comment in

Heart failure therapy: testosterone replacement and its implications.
Rauchhaus M, Doehner W, Anker SD. Rauchhaus M, et al. Eur Heart J. 2006 Jan;27(1):10-2. doi: 10.1093/eurheartj/ehi653. Epub 2005 Nov 16. Eur Heart J. 2006. PMID: 16291772 No abstract available.

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