Status:
TERMINATED
Protein-energy Oral Supplementation Enriched With Omega-3 Fatty Acids in Cardiac Cachexia
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Cardiac Cachexia
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
Cardiac cachexia, the main feature of undernutrition in chronic heart failure, usually defined as a weight loss over 6% over 6 months, is a proven factor of morbidity and mortality in this disease. It...
Detailed Description
Undernutrition is frequent in chronic heart failure (approximately 40%). Cardiac cachexia, main feature of this undernutrition, usually defined as a weight loss over 6% over 6 months, is a proven fact...
Eligibility Criteria
Inclusion
- Age between 18 and 85 years
- Weight loss between 6 and 10% during the last six months
- Chronic heart failure with end-systolic ejection fraction ≤ 40% (all stages of the NYHA classification)
- Triple therapy: ß-blockers, ACE inhibitors and diuretics
- Informed consent signed
- Affiliated with the French Sécurité Sociale
Exclusion
- Patent undernutrition: BMI \< 18.5 for ages \< 70 or \< 21 for ages ≥ 70 and/or weight loss \> 10% in the last six months
- Chronic cachectic condition:
- cancer
- chronic respiratory failure
- advanced organ failure
- hyperthyroidism
- rheumatoid arthritis
- AIDS
- type 1 diabetes
- Drugs affecting muscle mass (e.g., steroids)
- Condition (clinical or EKG) contra-indicating cycle ergometry
- Unstable acute disease
- Edema
- Flare-up of heart failure (BNP \> 500 ng/L)
- Intake of omega-3-containing nutritional supplements
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00748332
Start Date
March 1 2008
End Date
August 1 2012
Last Update
August 22 2012
Active Locations (1)
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1
Department of Gastro-entérologie
Nice, France, 06000