Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
Study NCT ID:
NCT07273994
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Two Different Regimens of the Antiarrhythmic Drug Amiodarone to Maintain Normal Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000638', 'term': 'Amiodarone'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 312}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Plasma levels - polymorphisms', 'timeFrame': '12 month follow-up', 'description': 'Correlation of amiodarone plasma levels with polymorphisms'}], 'primaryOutcomes': [{'measure': 'Maintenance of sinus rhythm', 'timeFrame': '12 months follow-up', 'description': 'Number of patients mantaining sinus rhythm 12 months post electrical cardioversion'}], 'secondaryOutcomes': [{'measure': 'Adverse effects', 'timeFrame': '12 months follow-up', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}, {'measure': 'Polymorphisms', 'timeFrame': '12 months follow-up', 'description': 'Association of the different assessed polymorphisms with the primary and first secondary outcome'}, {'measure': 'Plasma levels', 'timeFrame': '12 months follow-up', 'description': 'Correlation of amiodarone plasma levels during follow-up with the maintenance of sinus rhythm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'Electrical cardioversion', 'Amiodarone', 'Pharmacogenetics', 'Adverse effects'], 'conditions': ['Persistent Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': '\\---\n\nThe goal of this clinical trial is to learn if reduced doses of amiodarone can treat atrial fibrillation (AF) effectively while minimizing toxic side effects in patients with persistent AF after electrical cardioversion. The main questions it aims to answer are:\n\n* Can a reduced dose of amiodarone (100 mg/day) maintain sinus rhythm as effectively as the standard dose (200 mg/day) 12 months post electrical cardioversion?\n* What are the adverse effects of the standard and reduced doses of amiodarone during 12 months post electrical cardioversion?\n* How do genetic polymorphisms affect the efficacy and safety of amiodarone?\n* How do amiodarone plasma levels correlate with the maintenance of sinus rhythm and genetic polymorphisms?\n\nResearchers will compare the standard dose (200 mg/day) to the reduced dose (100 mg/day) to see if the reduced dose offers a better balance between efficacy and safety.\n\nParticipants will:\n\n* Be treated with full dose amiodarone (200 mg/day) during the first month after electrical cardioversion.\n* Be randomized to either continue with the full dose (200 mg/day) or switch to the reduced dose (100 mg/day).\n\nThe study is a multicenter, randomized clinical trial involving 312 patients with persistent AF after successful electrical cardioversion. Participants will be followed for 12-18 months to monitor the recurrence of AF and adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Patients aged ≥ 18 years\n2. Documented persistent atrial fibrillation (≥ 7 days in duration)\n3. Electively referred for Electrical Cardioversion\n4. Signed informed consent.\n\nExclusion Criteria\n\n1. Urgent electrical cardioversion\n2. Atrial fibrillation post-cardiac surgery\n3. Previous myocardial infarction\n4. New York Heart Association (NYHA) Class IV heart failure\n5. Left ventricular ejection fraction (LVEF) \\<45%\n6. Significant left ventricular hypertrophy (wall thickness ≥ 15mm)\n7. Hyperthyroidism or hypothyroidism\n8. Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST \\> 3 x upper limit of normal (ULN)\n9. Allergy, intolerance, or known hypersensitivity to study medications\n10. Women of childbearing potential unwilling to use contraceptive measures and breastfeeding women.\n11. Participation in another clinical trial involving investigational drugs\n12. Life expectancy less than 12 months\n13. Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction.\n14. Patients with contraindications to amiodarone, such as uncontrolled thyroid dysfunction, severe sinus bradycardia, second- or third-degree AV block without a pacemaker, and a history of amiodarone-induced pulmonary toxicity.\n15. Patients in whom chronic amiodarone treatment previously failed to maintain sinus rhythm\n16. Patients with abnormal baseline QTc (\\>450 ms in males and \\>470 in females) or abnormal ECG that precludes QTc assessment\n17. Patients requiring concomitant medications that have a higher risk of QTc prolongation.\n18. Patient do not have a smart mobile phone or do not know how to use it adequately.'}, 'identificationModule': {'nctId': 'NCT07273994', 'acronym': 'PERIVERSION-2', 'briefTitle': 'Evaluation of Two Different Regimens of the Antiarrhythmic Drug Amiodarone to Maintain Normal Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Multicenter Randomized Clinical Trial To Evaluate Two Different Amiodarone Regimens To Maintain Sinus Rhythm After Electrical Cardioversion In Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'IIBSP-AMI-2024-33'}, 'secondaryIdInfos': [{'id': 'Project PI023/1768', 'type': 'OTHER_GRANT', 'domain': 'Instituto Salud Carlos III, Ministry of Science, Innovation and Universities, Government of Spain.'}, {'id': '2024-514113-35-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amiodarone full doses', 'description': 'Patients will receive amiodarone full doses (200 mg/day) (Usual dose)', 'interventionNames': ['Drug: Amiodarone Hydrochloride 200 MG']}, {'type': 'EXPERIMENTAL', 'label': 'Amiodarone reduced doses', 'description': 'Patients will receive amiodarone reduced doses (100 mg/day)', 'interventionNames': ['Drug: Amiodarone Hydrochloride 100 MG']}], 'interventions': [{'name': 'Amiodarone Hydrochloride 200 MG', 'type': 'DRUG', 'description': 'Patients will receive full amiodarone daily doses: 200 mg/day', 'armGroupLabels': ['Amiodarone full doses']}, {'name': 'Amiodarone Hydrochloride 100 MG', 'type': 'DRUG', 'description': 'Patients will receive amiodarone reduced daily doses: 100 mg/d', 'armGroupLabels': ['Amiodarone reduced doses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose M Guerra, MD, PhD', 'role': 'CONTACT', 'email': 'jguerra@santpau.cat', 'phone': '+34 935565945'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Jose M Guerra, MD, PhD', 'role': 'CONTACT', 'email': 'jguerra@santpau.cat', 'phone': '+34 935565945'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}