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

Terminated

• Conditions: Congestive Heart Failure
• Interventions: Drug: testosterone

• Registration Number: NCT00512408
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study Completion: 2007-03
• Status Verified: 2007-08
• Study First Submitted: 2007-08-06
• Study First Submitted QC: 2007-08-06
• Study First Posted: 2007-08-07
• Last Update Submitted: 2008-10-16
• Last Update Posted: 2008-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	testosterone	-

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Rome, Italy