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

NCT00512408 · Status: TERMINATED · Type: OBSERVATIONAL

Last updated 2008-10-17

No results posted yet for this study

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.

Conditions

  • Congestive Heart Failure

Interventions

DRUG

testosterone

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • maurizio volterrani, md · IRCCS san Raffaele Cardiovascular Research Unit

  • giuseppe marazzi, md · IRCCS san Raffaele Cardiovascular Research Unit

  • massaro rosalba, md · IRCCS san Raffaele Cardiovascular Research Unit

  • marco miceli · IRCCS san Raffaele Cardiovascular Research Unit

  • caterina mammi · IRCCS san Raffaele Cardiovascular Research Unit

  • massimo fini, md · IRCCS san Raffaele Cardiovascular Research Unit

  • giuseppe rosano, md · IRCCS san Raffaele Cardiovascular Research Unit

Eligibility

Min Age
56 Years
Max Age
76 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Completion
2007-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00512408 on ClinicalTrials.gov