Clinical trial NCT00512408: Testosterone Improves Exercise Oxygen Uptake, Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure
Official title: Long-Acting Testosterone Improves Exercise Oxygen Uptake, Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congestive Heart Failure
Keywords: To assess the effect of a 12 week testosterone administration on maximal exercise capacity, muscle strength and insulin resistance in elderly CHF patients
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2007-08-07
Sex: MALE
Minimum age (years): 56
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE

Brief 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS San Raffaele
Study officials:
affiliation: IRCCS san Raffaele Cardiovascular Research Unit
name: maurizio volterrani, md
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS san Raffaele Cardiovascular Research Unit
name: giuseppe marazzi, md
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS san Raffaele Cardiovascular Research Unit
name: massaro rosalba, md
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS san Raffaele Cardiovascular Research Unit
name: marco miceli
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS san Raffaele Cardiovascular Research Unit
name: caterina mammi
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS san Raffaele Cardiovascular Research Unit
name: massimo fini, md
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS san Raffaele Cardiovascular Research Unit
name: giuseppe rosano, md
role: STUDY_DIRECTOR
References:
citation: Schwartz JB, Volterrani M, Caminiti G, Marazzi G, Fini M, Rosano GM, Iellamo F. Effects of testosterone on the Q-T interval in older men and older women with chronic heart failure. Int J Androl. 2011 Oct;34(5 Pt 2):e415-21. doi: 10.1111/j.1365-2605.2011.01163.x. Epub 2011 May 25.