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

This study has been terminated.
Sponsor:
Information provided by:
IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT00512408
First received: August 6, 2007
Last updated: October 16, 2008
Last verified: August 2007
  Purpose

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 Intervention
Congestive Heart Failure
Drug: testosterone

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Long-Acting Testosterone Improves Exercise Oxygen Uptake, Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Study Start Date: July 2006
Study Completion Date: March 2007

  Eligibility

Ages Eligible for Study:   56 Years to 76 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by IRCCS San Raffaele

Additional 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
Study First Received: August 6, 2007
Last Updated: October 16, 2008
Health Authority: Italy: Ethics Committee

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
Cardiovascular Diseases
Glucose Metabolism Disorders
Heart Diseases
Hyperinsulinism
Metabolic Diseases
Insulin
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014