title: Testosterone therapy in women with chronic heart failure: a pilot double-blind, randomized, placebo-controlled study.
abstract: OBJECTIVE
  The primary objective of this study was to assess the effect of a 6-month testosterone supplementation therapy on functional capacity and insulin resistance in female patients with chronic heart failure (CHF).
  
  
  BACKGROUND
  Patients with CHF show decreased exercise capacity and insulin sensitivity. Testosterone supplementation improves these variables in men with CHF. No study has evaluated the effects of testosterone supplementation on female patients with CHF.
  
  
  METHODS
  Thirty-six elderly female patients with stable CHF, (ejection fraction 32.9 ± 6) were randomly assigned (2:1 ratio) to receive testosterone transdermal patch (T group, n = 24) or placebo (P group, n = 12), both on top of optimal medical therapy. At baseline and after 6 months, patients underwent 6-min walking test (6MWT), cardiopulmonary exercise test, echocardiogram, quadriceps maximal isometric voluntary contraction, dynamic quadriceps isokinetic strength (peak torque), and insulin resistance assessment by homeostasis model.
  
  
  RESULTS
  Distance walked at 6MWT as well as peak oxygen consumption significantly improved in the T group, whereas they were unchanged in the P group (p < 0.05 for all comparisons). The homeostasis model was significantly reduced in the T group in comparison with the P group (-16.5% vs. +5%, respectively; p < 0.05). Maximal voluntary contraction and peak torque increased significantly in the T group but did not change in the P group. Increase in distance walked at 6MWT was related to the increase in free testosterone levels (r = 0.593, p = 0.01). No significant changes in echocardiographic parameters were observed in either group. No side effects requiring discontinuation of T were detected.
  
  
  CONCLUSIONS
  Testosterone supplementation improves functional capacity, insulin resistance, and muscle strength in women with advanced CHF. Testosterone seems to be an effective and safe therapy for elderly women with CHF.
authors.affiliation: Department of Medical Sciences, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Roma, Roma, Italy. iellamo@med.uniroma2.it
authors.forename: Ferdinando
authors.initials: F
authors.lastname: Iellamo
authors.forename: Maurizio
authors.initials: M
authors.lastname: Volterrani
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Caminiti
authors.forename: Roger
authors.initials: R
authors.lastname: Karam
authors.forename: Rosalba
authors.initials: R
authors.lastname: Massaro
authors.forename: Massimo
authors.initials: M
authors.lastname: Fini
authors.forename: Peter
authors.initials: P
authors.lastname: Collins
authors.forename: Giuseppe M C
authors.initials: GM
authors.lastname: Rosano
mesh_terms: D000368:Aged; D000728:Androgens / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012720:Severity of Illness Index; D013318:Stroke Volume / Q000187:drug effects*; D013739:Testosterone / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000728:Androgens; D013739:Testosterone