Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-27 @ 8:33 AM
Study NCT ID:
NCT06029192
Status:
UNKNOWN
Last Update Posted:
2023-09-08
First Post:
2023-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diastolic Function in Myotonic Dystrophy Type 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-07', 'studyFirstSubmitDate': '2023-07-21', 'studyFirstSubmitQcDate': '2023-09-07', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': '7 years'}], 'secondaryOutcomes': [{'measure': 'Incidence of arrhythmia', 'timeFrame': '7 years'}, {'measure': 'acute heart failure', 'timeFrame': '7 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diastolic Dysfunction']}, 'descriptionModule': {'briefSummary': 'Myotonic dystrophy type 1 (DM1) is a neuromuscular disorder in relation with an unstable expansion of CTG repeat. Patients with DM1 are at risk of arrhythmia and conduction disorders. Mortality are mainly related to respiratory failure and sudden death. Patients with DM1 may suffer from obesity, arterial hypertension, diabetes mellitus and sleep apnea. These comorbidities are classically associated with left ventricular diastolic dysfunction (DD) .\n\nThe investigators aim to assess the prevalence of left ventricular diastolic dysfunction in patients with myotonic dystrophy type 1 , the distribution of DD grading as well as the long-term prognosis of DM1 patients with a left ventricular diastolic dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with myotonic dystrophy type 1 followed in a tertiary reference center.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with genetic proven myotonic dystrophy type 1\n* who experienced a Doppler- Echocardiography including an assessment of the left ventricular diastolic function\n\nExclusion Criteria:\n\n* wall motion basal abnormalities\n* significant valvular disease'}, 'identificationModule': {'nctId': 'NCT06029192', 'briefTitle': 'Diastolic Function in Myotonic Dystrophy Type 1', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'Diastolic Function in Myotonic Dystrophy Type 1', 'orgStudyIdInfo': {'id': 'ECHO-DM1'}}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ABDALLAH FAYSSOIL, MDPhD', 'role': 'CONTACT', 'email': 'abdallah.fayssoil@aphp.fr', 'phone': '003347101411'}], 'facility': 'Hopital Raymond Poincare', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'centralContacts': [{'name': 'Abdallah FAYSSOIL, MD PhD', 'role': 'CONTACT', 'email': 'abdallah.fayssoil@aphp.fr', 'phone': '+33147107778'}], 'overallOfficials': [{'name': 'Abdallah FAYSSOIL, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Raymond Poincare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Abdallah FAYSSOIL', 'investigatorAffiliation': "Centre d'Investigation Clinique et Technologique 805"}}}}