Status:
UNKNOWN
Multimodal Approach of Undernutrition in Chronic Heart Failure
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Durtol clinical center
Centre Hospitalier Universitaire de Saint Etienne
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The treatment of chronic heart failure (CHF) is a key challenge in public health. Despite medical advances, 1-year mortality of NYHA III-IV CHF is 28%. Undernutrition is an independent risk factor for...
Detailed Description
Study aims : Main study aim : To evaluate the impact of a 3-month multimodal approach associating exercise rehabilitation, androgen substitution, n-3 PUFAs and ONS on exercise capacity of undernouri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01864733
Start Date
May 1 2013
End Date
May 1 2016
Last Update
May 30 2013
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003