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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00512408
Recruitment Status : Terminated
First Posted : August 7, 2007
Last Update Posted : October 17, 2008
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Congestive Heart Failure Drug: testosterone

Study Design

Study Type : Observational
Time Perspective: Prospective
Official Title: Long-Acting Testosterone Improves Exercise Oxygen Uptake, Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure
Study Start Date : July 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
A Drug: testosterone
B


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   56 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512408


Locations
Italy
IRCCS San Raffaele
Rome, Italy, 00163
Sponsors and Collaborators
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
Study Director: giuseppe rosano, md IRCCS san Raffaele Cardiovascular Research Unit
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00512408     History of Changes
Other Study ID Numbers: 002-07
First Posted: August 7, 2007    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: August 2007

Keywords provided by IRCCS San Raffaele:
To assess the effect of a 12 week testosterone administration on maximal exercise capacity, muscle strength and insulin resistance in elderly CHF patients

Additional relevant MeSH terms:
Heart Failure
Insulin Resistance
Heart Diseases
Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Hypoglycemic Agents
Physiological Effects of Drugs
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents