Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 3:25 AM
Study NCT ID:
NCT03418467
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-28
First Post:
2018-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors in Tachycardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001282', 'term': 'Atrial Flutter'}, {'id': 'D018879', 'term': 'Ventricular Premature Complexes'}], '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': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2018-01-24', 'studyFirstSubmitQcDate': '2018-01-31', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'histological characteristics', 'timeFrame': '3 months', 'description': 'Identification of histopathological criteria, which indicate better outcome after rhythm control. Recovery of left ventricular ejection fraction (assessed by echocardiography) will be measured.'}], 'secondaryOutcomes': [{'measure': 'recurrence of rhythm disturbance', 'timeFrame': '3 months', 'description': 'Evaluating the recurrence of the underlying rhythm disturbance (ECG, 7 day holter monitoring, implantable event recorder)'}, {'measure': 'rehospitalization', 'timeFrame': '3 months', 'description': 'Evaluating the rate of unplanned rehospitalization'}, {'measure': 'all-cause mortality', 'timeFrame': '3 months', 'description': 'Evaluating the all-cause mortality'}, {'measure': 'NYHA class (New York Heart Association)', 'timeFrame': '3 months', 'description': 'Evaluating the extend of heart failure symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tachycardiomyopathy', 'atrial fibrillation', 'EMID (enrichment of mitochondria at the intercalated discs)', 'Biopsy', 'empathy'], 'conditions': ['Atrial Fibrillation', 'Atrial Flutter', 'Ventricular Premature Complexes']}, 'descriptionModule': {'briefSummary': 'Decision between rate control and rhythm control can be a challenge in clinical practice. While there is some guiding evidence, we still lack a comprehensive insight into different subgroups of patients that will benefit from a rhythm control treatment.\n\nEMPATHY is a prospective clinical study in patients presenting with heart failure and a tachyarrhythmic rhythm disturbance. Biomarkers, routinely obtained results from clinical examinations, and results from endomyocardial biopsies shall be evaluated to identify patients which have better outcome from a rhythm control strategy by ablation therapy or, if contraindicated by pharmacological rhythm control.\n\nThis study is designed to identifying risk factors and subgroups profiting from rhythm restoration and therefore improve current therapeutic approaches and the rate of recurrence-free survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting at the University Hospital Tübingen with decreased left ventricular ejection fraction.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newly diagnosed left ventricular ejection fraction ≤ 50%\n* endomyocardial biopsy available\n* tachycardic rhythm disturbance with a rhythm control strategy planned for tachycardic atrial fibrillation or flutter (≥100/min) or more than 10000 ventricular premature beats in 24 hours\n\nExclusion Criteria:\n\n* age \\<18 years\n* patient unable or unwilling to give informed consent\n* coronary artery stenosis \\>50%\n* relevant valvular disease\n* simultaneous contraindications against amiodarone treatment and pulmonary vein isolation/ablation therapy\n* present or suspected alcohol/drug dependency will result in exclusion from the study'}, 'identificationModule': {'nctId': 'NCT03418467', 'acronym': 'EMPATHY', 'briefTitle': 'Risk Factors in Tachycardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Evaluation of Risk Factors for Therapeutic Outcome in Patients with Tachycardiomyopathy', 'orgStudyIdInfo': {'id': 'EMPATHY-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'tachycardiomyopathy', 'description': 'Sustained heart rate of over 100 bpm, exclusion of other causes of congestive heart failure including significant valvular disease and coronary artery stenosis over 50%, and partial or complete recovery of left ventricular function after restoration of sinus rhythm or rate control and characteristic histological findings.'}, {'label': 'dilated cardiomyopathy', 'description': 'Patients with dilated cardiomyopathy according to the 2016 ESC (European Heart Association) Guidelines for the diagnosis and treatment of acute and chronic heart failure.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitätsklinikum Tübingen, Medizinische Klinik III (Kardiologie)', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}