Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-01 @ 2:26 AM
Study NCT ID:
NCT06465134
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to recurrence of AF measured on 7 days electrocardiography at month 3, 6, 12', 'timeFrame': 'one year', 'description': 'Recurrence of atrial fibrillation after AF ablation or cardioversion'}], 'secondaryOutcomes': [{'measure': 'aortic stiffness measured by tonometry; pulse wave velocity (m/s)', 'timeFrame': 'baseline measurements', 'description': 'measured aortic stiffness (measured as pulse wave velocity in m/s) in subjects with OSA compared to those without OSA in the cohort'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Obstructive Sleep Apnea', 'Hypertension', 'Autonomic Dysfunction', 'Arterial Stiffness']}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation (AF) is the most common rhythm disorder and involves an increased risk of cardiovascular disease and death, impaired quality of life and a high proportion of healthcare consumption. An important risk factor is obstructive sleep apnea (OSA). However, it is not fully understood why OSA induces AF. It may be due to a proinflammatory state, sympathetic activation and acute changes in blood pressure during apnéas, but few studies are performed. Hypertension with its coherent arterial stiffness is related to all these factors, is common in OSA, and is the most common cause of AF. The cause of AF in hypertensive subjects is believed due to a pressure overloaded left heart, with dilation and fibrosis of the left atrium, promoting the development of AF. Hypertension and arterial stiffness can thus be important triggering factors for AF in OSA.\n\nIn this project, teh investigators investigate the occurrence of OSA in AF patients. Furthermore, underlying mechanisms for the development and recurrence of AF after intervention in OSA patients are investigated.\n\n300 patients scheduled for AF ablation or cardioversion are invited and examined with sleep registration, 24h blood pressure, aortic stiffness measurement, test of autonomic function, echocardiography, ECG and labs. The patients are followed at months 3, 6 and 12 with 7 days ECG for recurrence. The aim is to give insights into the need for screening for OSA in patients with AF. The study also aim at enabling preventive treatment through better understanding of underlying treatable mechanisms. The results are believed to lead to fewer new AFs, as well as fewer AF recurrences in patients with OSA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at San Luca Hospital Cattinara Hospital Italy, and Danderyd Hospital Sweden are used. Patients with atrial fibrillation scheduled for AF ablation or cardioversion are selected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years scheduled for AF ablation or cardioversion\n\nExclusion Criteria:\n\ndiagnosis of AF for more than 7 years\n\n* previous cardiac surgery including AF ablation\n* severe valvular heart disease\n* diagnosed structural heart disease\n* systolic function in sinus rhythm \\<50%.\n* severe hypertensive heart disease or known hypertrophic heart disease (amyloidosis, hereditary hypertrophic heart disease)\n* invalidating chronic diseases imaging material on echocardiography not of sufficient quality.'}, 'identificationModule': {'nctId': 'NCT06465134', 'acronym': 'AF-MiTriSto', 'briefTitle': 'Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Danderyd Hospital'}, 'officialTitle': 'Mechanisms for Incident and Recurrent Atrial Fibrillation in Patients With Obstructive Sleep Apnea; AF - Milano Trieste Stockholm', 'orgStudyIdInfo': {'id': 'KAROLINSKA INSTITUTE, DANDERYD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients scheduled for AF ablation or cardioversion', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'There is no intervention', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20145', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianfranco Parati, Professor', 'role': 'CONTACT', 'email': 'parati@auxologico.it'}, {'name': 'Kristina Lundwall, MD PhD', 'role': 'CONTACT', 'email': 'kristina.lundwall@regionstockholm.se', 'phone': '+46731589999'}], 'facility': 'San Luca Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Trieste', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Grillo, MD PhD', 'role': 'CONTACT', 'email': 'andr.grillo@gmail.com'}, {'name': 'Kristina Lundwall, MD PhD', 'role': 'CONTACT', 'email': 'kristina.lundwall@regionstockholm.se', 'phone': '+46731589999'}], 'facility': 'Cattinara Hospital', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'zip': '182 88', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Kristina Lundwall, MD PhD', 'role': 'CONTACT', 'email': 'kristina.lundwall@regionstockholm.se', 'phone': '+46731589999'}, {'name': 'Kambiz Shahgaldi, Assoc prof', 'role': 'CONTACT', 'email': 'kambiz.shahgaldi@regionstockholm.se'}], 'facility': 'Danderyd Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Kristina Lundwall, MD PhD', 'role': 'CONTACT', 'email': 'kristina.lundwall@regionstockholm.se', 'phone': '+46731589999'}, {'name': 'Gianfranco Parati, Professor', 'role': 'CONTACT', 'email': 'parati@auxologico.it'}], 'overallOfficials': [{'name': 'Kristina Lundwall, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KAROLINSKA INSTITUTE, DANDERYD HOSPITAL'}, {'name': 'Gianfranco Parati, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Auxologico Italiano'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danderyd Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, {'name': 'University of Trieste', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}