Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT04703504
Status:
TERMINATED
Last Update Posted:
2024-10-04
First Post:
2021-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'Recruitment targets will not be met', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2021-01-08', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with a re-hospitalization due to heart decompensation', 'timeFrame': '3 months', 'description': 'Defined as occurence of the need for hospitalization for cardiac decompensation justifying the use of intravenous diuretic therapy.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with a re-hospitalization due to heart decompensation', 'timeFrame': '12 months', 'description': 'Defined as occurence of the need for hospitalization for cardiac decompensation justifying the use of intravenous diuretic therapy.'}, {'measure': 'Number of re-hospitalization due to heart decompensation per patient', 'timeFrame': '12 months', 'description': 'Defined as total number of hospitalization for heart decompensation during 1 year'}, {'measure': 'Delay between discharge and re-hospitalization due to heart decompensation', 'timeFrame': '12 months', 'description': 'Defined as time to first occurrence of re-hospitalization due to heart decompensation'}, {'measure': 'Number of participants with death', 'timeFrame': '3 months'}, {'measure': 'Number of participants with death', 'timeFrame': '12 months'}, {'measure': 'Rate of pacemaker implantation', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'multiple intervention program'], 'conditions': ['Heart Decompensation']}, 'descriptionModule': {'briefSummary': 'The prevalence of heart failure (HF) is constantly increasing in France due to the aging of the population, better management of etiological factors and improved treatments (drug / interventional). On the other hand, re-hospitalizations for heart failure continue to increase, exceeding reception capacities and constitute a real challenge for current public health systems. The PRADO system provides administrative support (through a health insurance advisor) in the management of patient appointments with their doctors as well as home visits by a nurse trained in heart failure. Other interventional medical and educational interventions performed during an out-of-hospital consultation guided by a computer platform would help to optimize the care and continuity of care.', 'detailedDescription': 'The aim of this study is to demonstrate the value of a multiple intervention program in reducing early readmissions for heat failure in patients hospitalized for cardiac decompensation.\n\nThis work will create an interventional assistance program to structure the exit consultation in order to optimize treatment, educate patients, ensure the continuity of hospital-city care and improve compliance (reminders) to reduce re-hospitalizations. This program will be carried out by using a computer platform allowing the systematization of output documents and the sending of messages (e-mail / SMS) for making appointments (medical consultations, biologicals sampling) and perfect therapeutic education.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart decompensation requiring hospitalization and the use of intravenous diuretic therapy\n* Left Ventricular Ejection Fraction ≤ 40%.\n\nExclusion Criteria:\n\n* Hospitalization for cardiac decompensation leading to an invasive procedure (valve, coronary, etc.).\n* Acute reversible cause of heart failure.\n* Incurable disease (other than heart failure) or estimated life expectancy of less than one year.\n* Patient transferred directly to another department or cardiac rehabilitation center.\n* Significant cognitive impairment.\n* Patient without cell phone or email.\n* Linguistic or psychic refusal or inability to sign the informed consent.\n* Current participation in a clinical tria'}, 'identificationModule': {'nctId': 'NCT04703504', 'acronym': 'RACING-HF', 'briefTitle': 'RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization', 'organization': {'class': 'OTHER', 'fullName': 'French Cardiology Society'}, 'officialTitle': 'RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization', 'orgStudyIdInfo': {'id': '2016-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'multi-intervention', 'description': '* Automatic creation of discharge prescription (personalized checklist of possible therapeutic optimizations generated from clinical data entered into the platform. This checklist will comply with the recommendations on altered left ventricular ejection fraction from European Society of Cardiology 2016.\n* Automatic creation of documents for patient:\n\n * Reminder letter to make an appointment with his general practitioner (at 7 days) and cardiologist (1 month) and to report the prescribed blood test.\n * Drug prescription.\n * Prescription for blood tests (5 days and 25 days before seeing the general practitioner and cardiologist).\n * Therapeutic education documents\n* Patients will receive numerous messages (SMS / e-mail) in order to 1 / not forget their medical appointments, 2 / not to forget to make and bring back their blood test for the consultation, 3 / to perfect the therapeutic education advice provided previously', 'interventionNames': ['Other: Multiple intervention program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "Discharge prescription according to the investigator's habits."}], 'interventions': [{'name': 'Multiple intervention program', 'type': 'OTHER', 'description': 'Support for patient follow-up assisted by a computer program', 'armGroupLabels': ['multi-intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Champigny-sur-Marne', 'country': 'France', 'facility': "Hôpital Paul d'Egine", 'geoPoint': {'lat': 48.81642, 'lon': 2.49366}}, {'city': 'Créteil', 'country': 'France', 'facility': 'Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Eaubonne', 'country': 'France', 'facility': 'Hôpital Simone Veil', 'geoPoint': {'lat': 48.99712, 'lon': 2.28249}}, {'zip': '69655', 'city': 'Gleizé', 'country': 'France', 'facility': 'Hôpitaux Nord-Ouest de Villefranche', 'geoPoint': {'lat': 45.98916, 'lon': 4.69708}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'Polyclinique de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Saint-Denis', 'country': 'France', 'facility': 'Centre Cardiologique du Nord', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'city': 'Villeneuve-Saint-Georges', 'country': 'France', 'facility': 'Centre Hopsitalier Lucie et Raymond Aubrac', 'geoPoint': {'lat': 48.73219, 'lon': 2.44925}}], 'overallOfficials': [{'name': 'Arnaud GALAT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Henri Mondor, Créteil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Cardiology Society', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}