Clinical Trials Directory

Trials / Terminated

TerminatedNCT00512408

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

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

Status
Terminated
Phase
Study type
Observational
Enrollment
Sponsor
IRCCS San Raffaele · Academic / Other
Sex
Male
Age
56 Years – 76 Years
Healthy volunteers

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGtestosterone

Timeline

Start date
2006-07-01
Completion
2007-03-01
First posted
2007-08-07
Last updated
2008-10-17

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT00512408. Inclusion in this directory is not an endorsement.