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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congestive Heart Failure

Keywords

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To assess the effect of a 12 week testosterone administration on maximal exercise capacity, muscle strength and insulin resistance in elderly CHF patients

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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A

testosterone

Intervention Type DRUG

B

No interventions assigned to this group

Interventions

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testosterone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

56 Years

Maximum Eligible Age

76 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No