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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00512408
• Other study ID #: 002-07
• Status: Terminated
• Phase: N/A
• First received: August 6, 2007
• Last updated: October 16, 2008
• Start date: July 2006
• Est. completion date: March 2007

Study information

• Verified date: August 2007
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: March 2007
• Gender: Male
• Age group: 56 Years to 76 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Insulin Resistance

Intervention

Drug:
• testosterone

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Rome

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy,