Cardiovascular Outcomes of Replacement with Testosterone. Role of testosterone replacement therapy in patients with heart failure. - CORTe

• Conditions: MALE HYPOGONADISM; MedDRA version: 9.1Level: SOCClassification code 10014698; MedDRA version: 9.1Level: SOCClassification code 10007541

• Registration Number: EUCTR2010-022821-14-IT
• Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-27
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Echocardiography assessed ejection fraction <40%. • heart failure in functional Nyah class II or III, with clinical stability of the disease and no hospitalization in the 3 months prior to enrollment. • Hypogonadism: total testosterone <12 nmol / L or calculated free testosterone <225 pmol / L.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Age <40 years • Mental incapacity or difficulty in correctly understanding the Italian language • Any medical or psychiatric condition not adequately controlled. moderate or severe liver or kidney failure. • Heart failure in NYHA class I or IV or underlying not stabilized disease. • uncontrolled Hypertension. Recent hospitalization <3 months. • Peripheral vascular disease or any other disease in the lower limbs that may limit the physician of the 6 minutes walking test. • Total testosterone> 12 nmol / l or calculated free testosterone> 225 pmol / L. • Known hypersensitivity to any component of the drug used in the study. • History of prostate cancer and breast cancer or suspicion of prostate cancer with digital rectal examination. • Level of PSA> 4 ng / ml. • Level of hematocrit> 50% • Severe obstructive urinary symptoms (score on IPSS> 19)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified