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

NCT00512408 | Terminated

• 1 other identifier: 002-07
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Study Arms (2)

A

Drug: testosterone

B

Interventions

testosterone DRUG

A

Eligibility Criteria

• Age: 56 Years - 76 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Rome, rome, 00163, Italy

Location

Related Publications (1)

• 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.

  PMID: 21615419 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• giuseppe rosano, md

  IRCCS san Raffaele Cardiovascular Research Unit

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 7, 2007
• Study Start: July 1, 2006
• Study Completion: March 1, 2007
• Last Updated: October 17, 2008

Record last verified: 2007-08

Locations

IT (1)