Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-28 @ 6:20 PM
Study NCT ID:
NCT00748332
Status:
TERMINATED
Last Update Posted:
2012-08-22
First Post:
2008-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein-energy Oral Supplementation Enriched With Omega-3 Fatty Acids in Cardiac Cachexia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-21', 'studyFirstSubmitDate': '2008-09-04', 'studyFirstSubmitQcDate': '2008-09-04', 'lastUpdatePostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VO2 max (cycle ergometry)', 'timeFrame': 'D0 and after 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Weight, BMI, body composition (DAX and BIA), muscle function (dynamometers), biology, quality of life, cardiac function (ultra-sound end-systolic ejection fraction, walking perimeter), food intake.', 'timeFrame': 'D0 and after 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Cachexia']}, 'descriptionModule': {'briefSummary': '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. Its pathophysiology is complex, but proinflammatory cytokines seem to play a major role. Omega-3 poly-unsaturated fatty acids, present in fish oil, have proven beneficial in patients with coronary heart disease, due in part to their effects on membranes but also due to their anti-inflammatory effects, with inhibition of TNF-α and interleukins 1 and 6.\n\nThe aim of this phase III randomized controlled double-blinded study is to assess the effects of 8 weeks of a omega-3-enriched protein-energy supplement versus an iso-energetic iso-nitrogenous supplement free of omega-3 fatty acids in cardiac cachexia. Thirty patients will be included in each group. The main judgment criterion will be maximum aerobic capacity (VO2 max), which best reflects aerobic capacity that correlates with muscle mass. Anthropometric, biological (nutritional, inflammatory and involved in food intake control), cardiac (functional) and quality of life will also be studied. All analyses will be performed in intention to treat.\n\nThe investigators expect a significantly higher improvement of VO2 max in the omega-3 group.\n\nThis study could lead to therapeutic advances in a frequent and severe disease.', 'detailedDescription': '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 factor of morbidity and mortality in this disease. Its pathophysiology is complex, but proinflammatory cytokines seem to play a major role, thus appearing close to cancer cachexia. A number of treatments have proven to be effective in preventing undernutrition in chronic heart failure patients (ß-blockers, ACE inhibitors, diuretics and physical training). Omega-3 poly-unsaturated fatty acids, present in fish oil, haven proven beneficial in patients with coronary heart disease, due in part to their effects on membranes but also due to their anti-inflammatory effects, with inhibition of TNF-α and interleukins 1 and 6. However, no study to this day has been conducted in human cardiac cachexia.\n\nThe aim of this phase III randomized controlled double-blinded study is to assess the effects of 8 weeks of a omega-3-enriched protein-energy supplement versus an iso-energetic iso-nitrogenous supplement free of omega-3 fatty acids in cardiac cachexia. Thirty patients will be included in each group. The main judgment criterion will be maximum aerobic capacity (VO2 max), which best reflects aerobic capacity that correlates with muscle mass. Anthropometric, biological (nutritional, inflammatory and involved in food intake control), cardiac (functional) and quality of life will also be studied. All analyses will be performed in intention to treat.\n\nWe expect a significantly higher improvement of VO2 max in the omega-3 group. This study could lead to therapeutic advances in a frequent and severe disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 85 years\n* Weight loss between 6 and 10% during the last six months\n* Chronic heart failure with end-systolic ejection fraction ≤ 40% (all stages of the NYHA classification)\n* Triple therapy: ß-blockers, ACE inhibitors and diuretics\n* Informed consent signed\n* Affiliated with the French Sécurité Sociale\n\nExclusion Criteria:\n\n* Patent undernutrition: BMI \\< 18.5 for ages \\< 70 or \\< 21 for ages ≥ 70 and/or weight loss \\> 10% in the last six months\n* Chronic cachectic condition:\n\n * cancer\n * chronic respiratory failure\n * advanced organ failure\n * hyperthyroidism\n * rheumatoid arthritis\n * AIDS\n * type 1 diabetes\n* Drugs affecting muscle mass (e.g., steroids)\n* Condition (clinical or EKG) contra-indicating cycle ergometry\n* Unstable acute disease\n* Edema\n* Flare-up of heart failure (BNP \\> 500 ng/L)\n* Intake of omega-3-containing nutritional supplements'}, 'identificationModule': {'nctId': 'NCT00748332', 'briefTitle': 'Protein-energy Oral Supplementation Enriched With Omega-3 Fatty Acids in Cardiac Cachexia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Effects of a Protein-energy Oral Supplement Enriched With Omega-3 Fatty Acids Compared to a Standard Protein-energy Supplement in Cardiac Cachexia', 'orgStudyIdInfo': {'id': 'API 2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Standard oral nutritional supplement', 'interventionNames': ['Dietary Supplement: Fortimel Extra®']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Omega-3-enriched oral nutritional supplement', 'interventionNames': ['Dietary Supplement: Fortimel Care®']}], 'interventions': [{'name': 'Fortimel Extra®', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 bottles (600 kcal, 40 g proteins) per day', 'armGroupLabels': ['1']}, {'name': 'Fortimel Care®', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Fortimel Care® : 2 bottles (660 kcal, 36 g proteins, 2.38 g EPA) per day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Department of Gastro-entérologie', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Stéphane Schneider, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastroentrology of Nice University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}