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European Heart Journal Advance Access originally published online on August 10, 2005
European Heart Journal 2006 27(1):57-64; doi:10.1093/eurheartj/ehi443
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© The European Society of Cardiology 2005. All rights reserved. For Permissions, please e-mail: journals.permissions@oupjournals.org

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

Chris J. Malkin1, Peter J. Pugh1, John N. West1, Edwin J.R. van Beek2, T. Hugh Jones4 and Kevin S. Channer1,3,*

1Department of Cardiology, Royal Hallamshire Hospital, Sheffield S10 2JF, UK
2Department of Radiology, Royal Hallamshire Hospital, Sheffield S10 2JF, UK
3Faculty of Health and Well-being, Sheffield Hallam University, Sheffield S1 1WB, UK
4Centre for Diabetes and Endocrinology, Barnsley District General Hospital, Barnsley S75 2EP, UK

Received 22 December 2004; revised 1 July 2005; accepted 14 July 2005; online publish-ahead-of-print 10 August 2005.

* Corresponding author. Tel: +44 114 271 1900; fax: +44 114 271 2042. E-mail address: kevin.channer{at}sth.nhs.uk

See page 10 for the editorial comment on this article (doi:10.1093/eurheartj/ehi653)

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.

Key Words: Heart failure • Testosterone • Shuttle walk test


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