Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-31 @ 5:57 PM
Study NCT ID:
NCT04904393
Status:
UNKNOWN
Last Update Posted:
2021-05-27
First Post:
2021-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subanalysis in Patients With CARDIoLAMinopathy Enrolled to REPORT-CCM Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-21', 'studyFirstSubmitDate': '2021-05-15', 'studyFirstSubmitQcDate': '2021-05-21', 'lastUpdatePostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of QoL', 'timeFrame': '12 months', 'description': 'Evaluation of the effect of CCM therapy on Quality of Life evaluated from the reduction of MLWHFQ score at FU post implant of CCM device compared to baseline.'}, {'measure': 'Reduction of HF Hospitalizations and Emergency Ward accesses', 'timeFrame': '12 months', 'description': 'Reduction of HF Hospitalizations and Emergency Ward accesses collected during the FU post implant of CCM device compared to number of Hospitalizations and Emergenncy Ward accesses collected 1 year before the implant of CCM therapy device'}, {'measure': 'Improvement of Fuctional Capacity', 'timeFrame': '12 months', 'description': 'Evaluation of the impact of CCM therapy on Functional Capacity evaluated from the gain of the distance travelled in the 6MWT at FU post implant of CCM therapy device compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Assess of HF biomarkers trends', 'timeFrame': '12 months', 'description': 'Assess of HF biomarkers trends (laminine, NT-ProBNP, copeptine) during the FU compared to baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'Cardiac Contyractility Modulation', 'Quality of Life'], 'conditions': ['Laminopathy', 'Lamin A/C Gene Mutation', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'Observational, retrospective registry with acute and chronic endpoints', 'detailedDescription': 'This registry includes patients who have undergone CCM device implant and due to the presence of heart failure with reduced left ventricular systolic function and symptomatic despite optimal therapy, with LMNA-DCM etiology for to assess the impact on CCM therapy in term of improvemente of QoL and reduction HF hospitalizations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with standard indication to CCM therapy device implantation with Cardiolaminopahy aetiology and in HF status.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-pregnant female, aged 18 or older;\n* chronic heart failure with symptomatic left ventricular systolic function (NYHA class II-IVa) with or without device already implanted (for example AICD, pace-maker);\n* Appropriate and optimized medical therapy;\n* Patient signed and dated informed consent form at enrollment;\n* life expectancy\\> 1 year due to the absence of comorbidities that reduce the prognosis\n\nExclusion Criteria:\n\n* absence of venous access available for implant;\n* contraindication to the interventional procedure of CCM device implant (for example presence of Mechanical tricuspid vale);\n* pregnant patients'}, 'identificationModule': {'nctId': 'NCT04904393', 'acronym': 'CARDILAM-CCM', 'briefTitle': 'Subanalysis in Patients With CARDIoLAMinopathy Enrolled to REPORT-CCM Registry', 'organization': {'class': 'OTHER', 'fullName': 'Monaldi Hospital'}, 'officialTitle': 'Subanalysis in Patients With CARDIoLAMinopathy Enrolled to Retrospective and Observational Registy on Cardiac Contractility Modulation Therapy', 'orgStudyIdInfo': {'id': 'CCM-002Mon'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Implant of the device for Cardiac Contractility Modulation (CCM) Therapy', 'type': 'DEVICE', 'description': 'The intervention is an implant of CCM therapy devices and it is similar to conventional dual chamber cardiac devices with only difference of to insert n 2 leads fixed in right ventricular septum'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': "Antonio D'Onofrio, MD", 'role': 'CONTACT', 'email': 'donofrioant1@gmail.com', 'phone': '+39 0817062605'}], 'facility': 'AO dei Colli - Monaldi Hospital', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'centralContacts': [{'name': "Antonio D'Onofrio, MD", 'role': 'CONTACT', 'email': 'donofrioant1@gmail.com', 'phone': '+39 0817062605'}, {'name': "Giuliano D'Alterio, MD", 'role': 'CONTACT', 'email': 'gdalterio@libero.it', 'phone': '+39 0817062605'}], 'overallOfficials': [{'name': "Antonio D'Onofrio, MD", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ao dei Colli - Monaldi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monaldi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of UOSD Elettrofisiologia Studio e Terapia delle Aritmie', 'investigatorFullName': "Antonio D'Onofrio", 'investigatorAffiliation': 'Monaldi Hospital'}}}}