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

October 16, 2008 updated by: IRCCS San Raffaele

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00163
        • IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: testosterone
B

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: maurizio volterrani, md, IRCCS san Raffaele Cardiovascular Research Unit
  • Principal Investigator: giuseppe marazzi, md, IRCCS san Raffaele Cardiovascular Research Unit
  • Principal Investigator: massaro rosalba, md, IRCCS san Raffaele Cardiovascular Research Unit
  • Principal Investigator: marco miceli, IRCCS san Raffaele Cardiovascular Research Unit
  • Principal Investigator: caterina mammi, IRCCS san Raffaele Cardiovascular Research Unit
  • Principal Investigator: massimo fini, md, IRCCS san Raffaele Cardiovascular Research Unit

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

August 6, 2007

First Submitted That Met QC Criteria

August 6, 2007

First Posted (Estimate)

August 7, 2007

Study Record Updates

Last Update Posted (Estimate)

October 17, 2008

Last Update Submitted That Met QC Criteria

October 16, 2008

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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