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| Sponsor: | IRCCS San Raffaele |
|---|---|
| Information provided by: | IRCCS San Raffaele |
| ClinicalTrials.gov Identifier: | NCT00512408 |
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 |
| Study Start Date: | July 2006 |
| Study Completion Date: | March 2007 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| A | Drug: testosterone |
| B |
Eligibility| Ages Eligible for Study: | 56 Years to 76 Years |
| Genders Eligible for Study: | Male |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| IRCCS San Raffaele | |
| Rome, Italy, 00163 | |
| 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
| 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 |
|
To assess the effect of a 12 week testosterone administration on maximal exercise capacity, muscle strength and insulin resistance in elderly CHF patients |
|
Heart Failure Insulin Resistance Heart Diseases Cardiovascular Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone |
Insulin Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents Hypoglycemic Agents |
