Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-01 @ 3:49 AM
Study NCT ID:
NCT00360958
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2006-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Severe Heart Failure by Ultrafiltration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014462', 'term': 'Ultrafiltration'}], 'ancestors': [{'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005374', 'term': 'Filtration'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-27', 'studyFirstSubmitDate': '2006-08-03', 'studyFirstSubmitQcDate': '2006-08-03', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of hospitalizations for heart failure', 'timeFrame': 'End of study'}], 'secondaryOutcomes': [{'measure': 'long term major adverse clinical events including death', 'timeFrame': 'End of study'}]}, 'conditionsModule': {'keywords': ['ultrafiltration', 'heart failure', 'fluid overload'], 'conditions': ['Severe Congestive Heart Failure']}, 'referencesModule': {'references': [{'pmid': '24269855', 'type': 'DERIVED', 'citation': 'Marenzi G, Muratori M, Cosentino ER, Rinaldi ER, Donghi V, Milazzo V, Ferramosca E, Borghi C, Santoro A, Agostoni P. Continuous ultrafiltration for congestive heart failure: the CUORE trial. J Card Fail. 2014 Jan;20(1):9-17. doi: 10.1016/j.cardfail.2013.11.004. Epub 2013 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'Patients with severe congestive heart failure show increased fluid body content which is often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients have frequent access to the emergency room and hospital for hemodynamic instability. Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The purpose of this study is to determine whether periodic ultrafiltration sessions maintain patients in stable clinical condition and reduce hospitalisations as well as access to emergency heart failure treatment.', 'detailedDescription': 'Patients with severe heart failure (New York Heart Association \\[NYHA\\] III-IV) and fluid overload will be randomized to ultrafiltration (UF group) or conventional medical treatment (Control group). Patients follow-up at least monthly visit for one year. Ultrafiltration will be repeated during follow-up in case of body weight gain due to fluid accumulation. Ultrafiltration will be performed during short term hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe heart failure (NYHA III-IV) with fluid overload\n* Ejection fraction \\< 40%\n* Estimated fluid overload \\> 4 kg\n\nExclusion Criteria:\n\n* Severe renal insufficiency\n* Acute pulmonary edema and/or cardiogenic shock'}, 'identificationModule': {'nctId': 'NCT00360958', 'briefTitle': 'Treatment of Severe Heart Failure by Ultrafiltration', 'organization': {'class': 'OTHER', 'fullName': 'Centro Cardiologico Monzino'}, 'officialTitle': 'Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure', 'orgStudyIdInfo': {'id': 'CCM S67/306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrafiltration', 'description': 'Ultrafiltration treatment', 'interventionNames': ['Procedure: ultrafiltration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual treatment', 'description': 'Usual HF treatment', 'interventionNames': ['Procedure: ultrafiltration']}], 'interventions': [{'name': 'ultrafiltration', 'type': 'PROCEDURE', 'armGroupLabels': ['Ultrafiltration', 'Usual treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20138', 'city': 'Milan', 'country': 'Italy', 'facility': 'Centro Cardiologico Monzino', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Piergiuseppe Agostoni, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Cardiologico Monzino'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Cardiologico Monzino', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Piergiuseppe Agostoni', 'investigatorAffiliation': 'Centro Cardiologico Monzino'}}}}