Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-09 @ 1:19 AM
Study NCT ID:
NCT05496504
Status:
COMPLETED
Last Update Posted:
2023-06-13
First Post:
2022-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Hypertension and Arrhythmia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-10', 'studyFirstSubmitDate': '2022-08-09', 'studyFirstSubmitQcDate': '2022-08-09', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arrhythmias during Holter ECG', 'timeFrame': '1-3 day(s)', 'description': 'Which kind of arrhythmias could be detected during repetitive Holter ECG in patients with PH?'}], 'secondaryOutcomes': [{'measure': 'Relation between arrhythmias and PH group, echocardiographic data, right heart catheterization data.', 'timeFrame': '1-3 day(s)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary hypertension', 'PH', 'arrhythmias', 'survival'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Patients with pulmonary hypertension underwent (routine) Holter ECG and were screened for (malignant) arrhyhtmias. Results of Holter ECGs were correlated with clinicial and technical data (echocardiography and right heart catheterization).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with PH of all groups', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Holter ECG -\n\nExclusion Criteria: None\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05496504', 'briefTitle': 'Pulmonary Hypertension and Arrhythmia', 'organization': {'class': 'OTHER', 'fullName': 'Asklepios Neurological Clinic Bad Salzhausen'}, 'officialTitle': 'Incidence and Prognostic Significance of (Malignant) Arrhythmias During Repetitive Holter Electrocardiograms in Patients With Pulmonary Hypertension', 'orgStudyIdInfo': {'id': 'PH09_08_2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Holter ECG', 'type': 'OTHER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asklepios Neurological Clinic Bad Salzhausen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Giessen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}