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:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT00748332
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00748332
Study Brief:
Protocol Section:
NCT00748332