Testosterone Improves Exercise Oxygen Uptake, Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure
Information source: IRCCS San Raffaele
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congestive Heart Failure
Intervention: testosterone (Drug)
Phase: N/A
Status: Terminated
Sponsored by: IRCCS San Raffaele Official(s) and/or principal investigator(s):
maurizio volterrani, md, Principal Investigator, Affiliation: IRCCS san Raffaele Cardiovascular Research Unit
giuseppe marazzi, md, Principal Investigator, Affiliation: IRCCS san Raffaele Cardiovascular Research Unit
massaro rosalba, md, Principal Investigator, Affiliation: IRCCS san Raffaele Cardiovascular Research Unit
marco miceli, Principal Investigator, Affiliation: IRCCS san Raffaele Cardiovascular Research Unit
caterina mammi, Principal Investigator, Affiliation: IRCCS san Raffaele Cardiovascular Research Unit
massimo fini, md, Principal Investigator, Affiliation: IRCCS san Raffaele Cardiovascular Research Unit
giuseppe rosano, md, Study Director, Affiliation: IRCCS san Raffaele Cardiovascular Research Unit
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.
Results: At baseline 30% of patients had hypogonadism. Peak VO2 (r 0. 44; P , 0. 02) and
quadriceps isometric strength (r 0. 39; P , 0. 01) were both positive related to serum
testosterone concentration. After three months, peak VO2 (13 ± 4 vs 16 ± 1 p 0. 02), VE/VCO2
(33 ± 7 vs 29 ±5 p 0. 01) distance walked at 6MWT (420 ± 45 vs 480 ± 51 p 0. 001),
significantly improved from baseline in the testosterone group while were unchanged in the
control group; HOMA-IR was significantly reduced in the testosterone group ( 2. 6 ± 1. 4 vs 1. 8
± 0. 8, p 0. 002). Maximal quadriceps isometric (130 ± 28 vs 166 ± 32, p 0. 04) but not
isokinetic strength was significantly increased at three months in the testosterone group.
Increase in testosterone levels were significantly related to improvement in peak VO2. No
significant changes in left ventricular function were found.
Conclusion: Long-acting testosterone therapy improves exercise capacity, muscle strength ed
glucose metabolism in men with moderately severe heart failure. Testosterone benefits seem to
be mediated by metabolic and peripheral effects.
Clinical Details
Official title: Long-Acting Testosterone Improves Exercise Oxygen Uptake, Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure
Study design: Natural History, Longitudinal, Random Sample, Prospective Study
Eligibility
Minimum age: 56 Years.
Maximum age: 76 Years.
Gender(s): 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.
Locations and Contacts
IRCCS San Raffaele, rome 00163, Italy
Additional Information
Starting date: July 2006
Ending date: March 2007
Last updated: August 6, 2007
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