Testosterone Improves Exercise Oxygen Uptake, Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure

San Donato Group (GSD)

Status: Terminated

Conditions: Congestive Heart Failure

Treatments: Drug: testosterone

Study type: Observational

Funder types: Other

Identifiers

NCT00512408

002-07

Details and patient eligibility

About

Background: Patients with congestive heart failure (CHF) show muscle mass wasting and decreased testosterone levels. Long-term testosterone supplementation improves walking distance and glucose metabolism of patients CHF. No studies have investigated the integrated effects of testosterone on exercise oxygen uptake muscle strength and glucose metabolism in patients with CHF regardless of the presence of hypogonadism.

Aim: To assess the effect of a 12 week testosterone administration on maximal exercise capacity, muscle strength and insulin resistance in elderly CHF patients.

Methods: Seventy elderly patients with stable CHF, mean age 71 ± 8 years, ejection fraction 34 ± 1%, NYHA class II/III 38/32, were enrolled. Of these, 35 were randomized to receive testosterone therapy (through intramuscular injection every 6 week) and 35 to receive placebo both on top of maximal medical therapy. At baseline and after 12 weeks all patients underwent echocardiogram, cardiopulmonary test, 6-minute walking test (6MWT), quadriceps maximal isometric and isokinetic strength.

Sex: Male

Ages: 56 to 76 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• left ventricular ejection fraction (LVEF) < 40%;
• New York Heart Association (NYHA) class II or III;
• clinical stability without hospital admission for heart failure in the previous 3 months.

Exclusion criteria

• unstable angina or recent acute myocardial infarction,
• history of severe liver diseases
• history of severe kidney diseases
• uncontrolled hypertension
• erythrocytosis (hematocrit > 50%)
• hyperviscosity
• prostate cancer, prostate-specific antigen (PSA) greater than 3 ng/ml
• severe lower urinary tract symptoms.

Trial design

0 participants in 2 patient groups

A

Treatment:

Drug: testosterone

B