Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT01864733
Eligibility Criteria:
Inclusion Criteria:
* Stable patients with CHF, defined by the absence of acute episodes since 2 months, and absence of exercise rehabilitation in the two last months
* NYHA III Heart failure
* VO2 peak \< 18 ml/kg/min
* Left ventricle ejection fraction ≤ 40%
* Age ≥ 18 years, informed, having given their consent
* Absence of acute disease
* Undernutrition, defined by :
* Involuntary weight loss ≥5% during the 12 last months, without any increase of diuretics doses
* or body mass index \<20
* or fat-free mass index assessed by BIA \<18 in men, and \<15 in women.
Exclusion Criteria:
* Heart failure related to pulmonary hypertension
* Heart failure treatable by surgery or angioplasty
* Patients eligible to ventricular resynchronisation
* Instable heart failure
* Patients waiting for transplantation
* On-going imunosuppressant or corticosteroids
* Disease affecting 6-month survival (end-stage cancer, or chronic disease,…)
* Positive VIH or hepatitis C serology
* Liver failure
* Respiratory insufficiency
* End-stage (stage 5) renal failure (creatinine clearance ≤15ml/kg/min)
* Acute disease
* Previous history of hormonal cancer (breast, prostate)
* Suspected or proved hormonal cancer (breast, prostate)
* Hypersensibility to testosterone or components of testosterone patch
* Liver tumor or previous history of liver tumor
* Unability or contra-indication to rehabilitation program (defined by the French society of Cardiology including contra-indication to physical exercise)
* Orthopedical limitations to exercise
* Type 2 diabetes requiring insulin since less than 3 months
* Patients having not giving their consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01864733
Study Brief:
Protocol Section:
NCT01864733