Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this clinical trial is to determine whether intermittent administration of testosterone against placebo is associated with a reduction of mortality and heart failure hospitalizations at 1 year, in male patients with advanced heart failure and testosterone deficiency.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Collaborators: Germans Trias i Pujol Hospital; Hospital Universitario Virgen de la Arrixaca
• Treatments: Methyltestosterone; Pharmaceutical Solutions; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• At least one hospital admission for HF.

• Stable clinical status, New York Heart Association (NYHA) functional class II-IV.

• Left ventricular ejection fraction of less than 40%

• NT-proBNP concentration greater than 1000 pg / ml.

• Total testosterone and free testosterone deficiency measured in the last month

• Age >18 years.

• Patients who have given their written informed consent.

Exclusion Criteria:

• No informed consent.

• Taking oral anticoagulants

• Severe valvular heart disease with an indication for surgical repair.

• Extracardiac disease with an estimated prognosis of less than 1 year.

• History of androgen-dependent prostate cancer, benign prostate hyperplasia treatment or prostate-specific antigen (PSA)> 3 ng / ml.

• History of breast carcinoma or liver tumor

• Severe renal impairment (glomerular filtration rate <30 ml / kg / min).

• Acute coronary syndrome in the last year

• Renal or hepatic failure

• Uncontrolled hypertension

• Erythrocytosis (hematocrit> 5%)

• Hypersensitivity to testosterone or any excipients.