Status:
COMPLETED
Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborating Sponsors:
Hospital Universitario Virgen de la Arrixaca
Germans Trias i Pujol Hospital
Conditions:
Heart Failure
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Heart Failure (HF) represents one of the major social and health problems, for its high prevalence and its huge economic impact, as well as the elevated morbidity and mortality associated. In Spain, t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01813201
Start Date
March 1 2011
End Date
March 1 2014
Last Update
December 13 2017
Active Locations (1)
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1
Cardiology Service, Hospital Universitario Virgen de la Arrixaca
Murcia, Spain, 30120