Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT06896266
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Characterization of Patients With Arrhythmia-Induced Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001282', 'term': 'Atrial Flutter'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 109}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cardiovascular Hospitalization', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Incidence of unplanned hospital admission due to a cardiovascular aethiology, including acute coronary syndrome, rhythm disorder, heart failure, valvular heart disease, cardiogenic syncope, ischaemic stroke or transient ischaemic attack, acute aortic syndrome, pulmonary or systemic embolism or unexplained sudden cardiac death.'}, {'measure': 'Mortality', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Death of any cause. Cardiovascular death will be also asesed'}], 'primaryOutcomes': [{'measure': 'Prevalence of pathogenic or likely pathogenic variants in genetic test', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Presence of pathogenic/likely pathogenic genetic variant in genetic test'}], 'secondaryOutcomes': [{'measure': 'Heart Failure Admission', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Incidence of new hospitalización or urgent visit due to heart failure requiring intravenous diuretics'}, {'measure': 'Arrhythmia recurrence', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Incidence of any atrial tachyarrhytmia (Atrial fibrillation, atrial flutter or atrial tachycardia) conditioning an atrial rate \\>150 beats per minute and with a duration of \\>5 minutes.'}, {'measure': 'New unplanned rhythm control procedure', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Incidence of unplanned electrical cardioversion or catheter ablation of an atrial tachyarrhythmia (Atrial fibrillation, atrial flutter or atrial tachycardia)'}, {'measure': 'Atrial reverse remodelling', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Incidence of atrial reverse remodelling (ARR). ARR will be considered with a decrease in \\>1 degree of atrial dilatation (0=non dilated; 1= mild; 2=moderate; 3=severe) or a decrease \\>15% in the left atrial indexed volume'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'atrial flutter', 'heart failure', 'arrhythmia-induced cardiomyopathy', 'cardiomyopathy', 'genetics'], 'conditions': ['Arrhythmia', 'Cardiomyopathy', 'Arrhythmia-induced Cardiomyopathy (AiCM)']}, 'referencesModule': {'references': [{'pmid': '38693772', 'type': 'BACKGROUND', 'citation': 'Serban T, Badertscher P, du Fay de Lavallaz J, Providencia R, Migliore F, Mugnai G, Penela D, Perrotta L, Kuhne M, Sticherling C, Chun KJ. Definition and management of arrhythmia-induced cardiomyopathy: findings from the European Heart Rhythm Association survey. Europace. 2024 May 2;26(5):euae112. doi: 10.1093/europace/euae112.'}, {'pmid': '38811098', 'type': 'BACKGROUND', 'citation': 'Shoureshi P, Tan AY, Koneru J, Ellenbogen KA, Kaszala K, Huizar JF. Arrhythmia-Induced Cardiomyopathy: JACC State-of-the-Art Review. J Am Coll Cardiol. 2024 Jun 4;83(22):2214-2232. doi: 10.1016/j.jacc.2024.03.416.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the genetic insights of arrhythmya-induced cardiomyopathy and its clinical prognosis. The main questions it aims to answer are:\n\nI. Does patients with arrhythmia-induced cardiomyopathy have a greater proportion of genetic mutations compared with other types of cardiomyopathy or general population? II. Have the genetics any prognostic impact in patients with arrhythmia-induced cardiomyopathy?', 'detailedDescription': 'This is a multicentric prospective observational study including patients with suspected arrhythmia-induced cardiomyopathy (AiC) and undergoing rhythm control strategy. AiC suspicion is defined by the presence of left ventricular ejection fraction \\<50% with no other more plausible explanation than a new-onset arrhythmia.\n\nPatients who met the inclusion/exclusion criteria will be followed during 1 year after the rhythm control procedure (electric cardioversion or catheter ablation) to asess rhythm control status, imaging remodeling and clinical events. A genetic test will be performed during the study time to asess the existace of genetic variants in cardiomyopathy-related genes. Follow-up visits will be scheduled at 2, 6 and 12 months after inclusion and electrocardiogram and echocardiography will be performed.\n\nAiC will be confirmed in case of left ventricular ejection fraction recovery \\>10% or absolute value \\>54% during the follow up imaging evaluations.\n\nPrimary analysis will asess the prevalence of pathogenic /likely patogenic variants in patients fullfilling AiC criteria and compared with those who not (without AiC). Secondary analysis will be focused on the incidence of cardiovascular events (heart failure-related and rhythm control-related) during the follow up and its relationship with the genetic background and the AiC status.\n\nImaging test during follow up will be performed and changes in ventricular and atrial parameters will be used to asess cardiac remodeling.\n\nFurther rhythm control asessment will be performed following routinary clinical practice in each participant center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with clinical suspected arrhythmia-induced cardiomyopathy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of atrial fibrillation or atrial flutter not self-limited.\n* Performance of a cardiac imaging test with systolic function analysis (echocardiogram, magnetic resonance, CT scan) during the clinical course of the arrhythmia, exhibiting a left ventricular ejection fraction (LVEF) \\<50%. In order for the test to be representative, the maximum time between the performance of the imaging test and the rhythm control procedure will be 3 months, in the absence of intervening cardiovascular events that may have caused a variation in LVEF. In the event that the patient had a previously known LVEF \\<50%, the change with respect to this attributable to tachyarrhythmia has to be ≥10%.\n* Signature of informed consent.\n* Ability to understand and accept participation in the study.\n\nExclusion Criteria:\n\n* Refusal of informed consent.\n* Legal or juridical incapacity.\n* Age \\<18 years.\n* Life expectancy less than 1 year.\n* Impossibility of a follow-up of at least 6 months.\n* Presence of a ventricular rate \\>140 beats per minute, limiting the validity of imaging measurements.\n* Presence of known factors causing systolic ventricular dysfunction:\n\n * Prior cardiomyopathy diagnosis.\n * Severe mitral or aortic valve disease.\n * Non-revascularizable ischemic heart disease.\n * Context of peri-resuscitation cardiopulmonary care.\n * Abusive alcohol consumption, defined as \\>80 grams of ethanol or \\>7 standard alcoholic beverages per day.\n * Active treatment with chemotherapeutic agents or radiation therapy to the thorax.\n * Known infection with Trypanosoma cruzi, Borrellia burgdorferi or other infectious agent causing cardiomyopathy.'}, 'identificationModule': {'nctId': 'NCT06896266', 'acronym': 'UNCHAINED-I', 'briefTitle': 'Genetic Characterization of Patients With Arrhythmia-Induced Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario 12 de Octubre'}, 'officialTitle': 'Understanding and Characterizing the Genetics of Patients With Arrhythmia-Induced Cardiomyopathy', 'orgStudyIdInfo': {'id': '24/391'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Patients with arrhytmia-induced cardiomyopathy criteria'}, {'label': 'B', 'description': 'Patients without arrhytmia-induced cardiomyopathy criteria'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15004', 'city': 'Ciudad Real', 'state': 'Castille-La Mancha', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jesús Piqueras-Flores, MD, PhD', 'role': 'CONTACT', 'email': 'jpiqueras@sescam.jccm.es', 'phone': '926278000'}], 'facility': 'Ciudad Real General University Hospital', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}, {'zip': '28004', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Martín Negreira Caamaño, MD, PhD', 'role': 'CONTACT', 'email': 'martin.negcam@gmail.com', 'phone': '+34913908000'}], 'facility': '12 de Octubre University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Albacete', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Sofía Calero-Nuñez, MD, PhD', 'role': 'CONTACT', 'email': 'sofia.caleron@gmail.com', 'phone': '967597100'}], 'facility': 'Albacete University Hospital Complex', 'geoPoint': {'lat': 38.99424, 'lon': -1.85643}}, {'city': 'Madrid', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Spain', 'facility': 'Ramón y Cajal University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Martín Negreira-Caamaño, MD, PhD', 'role': 'CONTACT', 'email': 'martin.negcam@gmail.com', 'phone': '+34913908000'}, {'name': 'Daniel Rodríguez-Muñoz, MD, PhD', 'role': 'CONTACT', 'email': 'daniel.rodriguez.mnz@gmail.com', 'phone': '+34913908000'}], 'overallOfficials': [{'name': 'Martín Negreira-Caamaño, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardiology department, 12 de Octubre University Hospital'}, {'name': 'Rafael Salguero-Bodes, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardiology Department, 12 de Octubre University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario 12 de Octubre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Martín Negreira-Caamaño, MD, PhD', 'investigatorAffiliation': 'Hospital Universitario 12 de Octubre'}}}}