Effect of Long-Acting Testosterone Treatment on Functional Exercise Capacity, Skeletal Muscle Performance, Insulin Resistance, and Baroreflex Sensitivity in Elderly Patients With Chronic Heart Failure - Testosterone Supplementation in Chronic Heart Failure

Aug 24, 2009
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Trial Sponsor:
Supported by the Italian Ministry of Health, as a part of Finalized Research 2005 Grant; also supported, in part, by Agenzia Spaziale Italiana, Grant ASI I/006/06/0.
Date Published:
01/01/2009
Date Updated:
08/24/2009
Original Posted Date:
08/24/2009
References

Description:

The goal of the trial was to evaluate treatment with long-acting testosterone therapy compared with placebo among elderly patients with chronic heart failure (CHF).

Hypothesis:

Testosterone therapy would be more effective in improving exercise capacity, ventilatory efficiency, muscle strength, and glucose metabolism.

Study Design

Study Design:

Patients Screened: 96
Patients Enrolled: 70
NYHA Class: 51% with NYHA class II, 49% with NYHA class III
Mean Follow Up: 12 weeks
Mean Patient Age: Median 71 years
Mean Ejection Fraction: 32%

Patient Populations:

  • Left ventricular ejection fraction <40%
  • Symptomatic HF with New York Heart Association functional class II or III
  • No HF admissions within the previous 3 months

Exclusions:

  • Unstable angina
  • Recent acute myocardial infarction
  • Severe liver, kidney, or lung disease
  • Uncontrolled hypertension
  • Erythrocytosis
  • Prostate cancer or prostate-specific antigen >3 ng/ml
  • Severe lower urinary tract symptoms
  • Lower extremity vascular or other diseases that would prevent exercise stress testing

Primary Endpoints:

  • Maximal exercise capacity
  • Ventilatory efficiency
  • Muscle strength
  • Insulin resistance
  • Baroreflex sensitivity

Drug/Procedures Used:

Elderly patients with CHF were randomized to an intramuscular injection of testosterone (1000 mg undecanoate) at baseline, then at 6 and 12 weeks (n = 35) versus intramuscular injection of saline at the same intervals (n = 35).

Concomitant Medications:

There was no difference in the use of baseline medications between the groups. In the testosterone group: antiplatelet agents 60%, anticoagulants 46%, beta-blockers 86%, angiotensin-converting enzyme inhibitors 91%, and statins 83%.

Principal Findings:

Overall, 70 patients were randomized. There was no difference in baseline characteristics between the groups. The median age was 71 years, mean ejection fraction was 32%, 26% had diabetes, and 34% had hypogonadism.

The change in peak VO2 over follow-up was 2.9 ml/kg/min in the testosterone group versus 0.3 ml/kg/min with placebo (p < 0.05 between groups). Similarly, the change in 6-minute walk test was 86 minutes versus 37 minutes (p < 0.05 between groups), change in quadriceps maximum voluntary contraction was 19 Nm versus 3.0 Nm (p < 0.05 between groups), and change in fasting insulinemia was -2.5 µU/ml versus -0.2 µU/ml (p < 0.05 between groups), respectively. The change in left ventricular ejection fraction was 0.6% versus -1.0% (p = NS between the groups), respectively.

Interpretation:

Among elderly patients with CHF receiving optimal medications, the use of testosterone (undecanoate 1000 mg) at baseline, then again at 6 and 12 weeks, appeared to be beneficial. This therapy improved peak oxygen consumption, exercise capacity, quadriceps muscle strength, and insulin sensitivity, despite no effect on left ventricular ejection fraction. Larger studies with longer follow-up are warranted.

References:

Caminiti G, Volterrani M, Iellamo F, et al. Effect of long-acting testosterone treatment on functional exercise capacity, skeletal muscle performance, insulin resistance, and baroreflex sensitivity in elderly patients with chronic heart failure: a double-blind, placebo-controlled, randomized study. J Am Coll Cardiol 2009;54:919-27.

Keywords: Follow-Up Studies, Insulin Resistance, Glucose, Hypogonadism, Muscle Strength, Oxygen Consumption, Heart Failure, Injections, Intramuscular, Stroke Volume, Quadriceps Muscle, Diabetes Mellitus, Fasting, Testosterone


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