Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 6:08 PM
Study NCT ID:
NCT05841056
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2023-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 ratio to receive amiodarone 200 mg maintenance therapy daily for four weeks or no maintenance therapy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2023-04-04', 'studyFirstSubmitQcDate': '2023-04-23', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Heart Failure', 'timeFrame': '90 days after randomization', 'description': 'Number of participants who experience heart failure'}, {'measure': 'Atrial Fibrillation', 'timeFrame': '90 days after randomization', 'description': 'Number of participants who experience atrial fibrillation'}, {'measure': 'A composite of stroke, myocardial infarction and cardiovascular death', 'timeFrame': '90 days after randomization', 'description': 'Number of participants who have at least one of the following: stroke, myocardial infarction or cardiovascular death'}, {'measure': 'Major bleeding', 'timeFrame': '90 days after randomization', 'description': 'Number of participants who experience a major bleed'}, {'measure': 'Systemic arterial embolism', 'timeFrame': '90 days after randomization', 'description': 'Number of participants who experience a systemic arterial embolism'}, {'measure': 'Atrial Fibrillation Effect on QualiTy of life (AFEQT) Questionnaire', 'timeFrame': 'Collected at baseline, 30 day follow-up and 90 day follow-up', 'description': 'The Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT) evaluates symptoms, daily activities, and treatment concerns participants have related to atrial fibrillation and will be completed on all participants'}, {'measure': 'SF-12 Questionnaire', 'timeFrame': 'Collected at baseline, 30 day follow-up and 90 day follow-up', 'description': 'The SF-12 questionnaire which assesses physical and mental health will be completed on all participants'}, {'measure': 'Electrical cardioversion', 'timeFrame': 'Randomization to 90 days', 'description': 'Proportion of participants who undergo electrical cardioversion'}], 'primaryOutcomes': [{'measure': '3 patients per center per month', 'timeFrame': '2 years', 'description': 'Ability to recruit an average of 3 participants per center per month'}, {'measure': 'Less than 10% cross-over rate', 'timeFrame': '28 days', 'description': 'Less than 10% cross-over rate'}, {'measure': 'Intervention group taking at least 80% of their amiodarone 4 week maintenance therapy', 'timeFrame': '28 days', 'description': 'Greater than and equal to 90% of the intervention group taking at least 80% of their amiodarone 4 week maintenance therapy'}, {'measure': '90% follow-up at 30 days', 'timeFrame': 'At 30 days post randomization date', 'description': 'Greater than and equal to 90% follow-up at 30 days'}], 'secondaryOutcomes': [{'measure': 'Burden of atrial fibrillation', 'timeFrame': 'In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose', 'description': 'Defined as percent time in atrial fibrillation'}, {'measure': 'Time to first AF > 6 minutes, >6 hours and >24 hours', 'timeFrame': 'In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose', 'description': 'Time to first AF \\> 6 minutes, \\>6 hours and \\>24 hours reported from the continuous ECG monitor'}, {'measure': 'Participants with at least one episode >6 minutes, >6 hours and >24 hours', 'timeFrame': 'In the 28 days measured by the continuous ECG monitor placed on the day after the participant finishes their 3-5g amiodarone loading dose', 'description': 'Proportion of participants with at least one episode \\> 6 minutes, \\>6 hours and \\>24 hours reported from the continuous ECG'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac surgery', 'heart rhythm monitoring', 'amiodarone'], 'conditions': ['Atrial Fibrillation New Onset']}, 'descriptionModule': {'briefSummary': 'The START-POAF pilot study is a prospective, open-label two-arm, randomized controlled trial with blinded assessment of outcomes (PROBE). This pilot study will assess Atrial Fibrillation (AF) recurrence and burden in patients with new-onset AF following cardiac surgery.', 'detailedDescription': 'Atrial fibrillation (AF) is the most common abnormal heart rhythm in the world. In patients who have cardiac surgery, new AF is found as an early complication in more than one out of every four surgeries. In the weeks and months after heart surgery, patients who have new AF take a medication called amiodarone to keep their heart in rhythm as it heals. If the heart goes back into AF, patients can have symptoms of heart racing, heart failure (fluid on the lungs) or stroke. Although amiodarone is effective, it can have side effects like dizziness, nausea and slow heart rate. It may also damage the lungs, liver and thyroid gland. Many patients are not able to complete their full prescribed course after surgery. Therefore, it is crucial that the investigators find the shortest possible length of treatment with amiodarone that will keep the heart in rhythm while minimizing the chance of side effects or organ damage. The START-POAF Pilot Randomized Trial will compare two different durations of amiodarone treatment: 1) in-hospital load only and 2) in-hospital load plus 4 weeks after loading dose. All participants will wear an electrocardiogram (ECG) monitor for 4 weeks the day after they complete their loading dose. The investigators will compare the amount of AF seen on the ECG between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged ≥18 years;\n2. Have undergone cardiac surgery including CABG, valve surgery, ascending aorta replacement, or combinations thereof within 14 days of randomization;\n3. Had new-onset POAF (or flutter), documented by 12-lead ECG or lasting ≥ 1 hour on telemetry. Patients can be in AF or sinus rhythm at the time of randomization;\n4. Expected to receive 3 g - 5 g of amiodarone loading dose post-surgery.\n5. Expected to be ready for hospital discharge within 48 h of randomization.\n\nExclusion Criteria:\n\n1. Documented preoperative history of paroxysmal, persistent or permanent AF;\n2. Planned use of a class I or III anti-arrhythmic drug (other than study drug);\n3. Patients who have undergone heart transplant, complex congenital heart surgery, isolated ventricular assist device insertion, or AF ablation (surgical or catheter);\n4. Known allergy to ECG adhesives;\n5. Contraindication to amiodarone (i.e. hyperthyroidism, severe restrictive or obstructive lung disease, Long QT syndrome, PR \\> 240 ms, high-grade AV block).\n6. Individuals who are pregnant, breastfeeding, or of childbearing potential - female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening'}, 'identificationModule': {'nctId': 'NCT05841056', 'acronym': 'START-POAF', 'briefTitle': 'Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients (START-POAF) Pilot Trial', 'orgStudyIdInfo': {'id': '2023.START-POAF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amiodarone maintenance therapy', 'description': 'Amiodarone 200 mg daily for four weeks', 'interventionNames': ['Drug: Amiodarone Hydrochloride 200 MG']}, {'type': 'NO_INTERVENTION', 'label': 'No Amiodarone maintenance therapy', 'description': 'No ongoing Amiodarone maintenance therapy for four weeks'}], 'interventions': [{'name': 'Amiodarone Hydrochloride 200 MG', 'type': 'DRUG', 'otherNames': ['Pacerone', 'Cordarone'], 'description': '200 mg daily for 4 weeks', 'armGroupLabels': ['Amiodarone maintenance therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Leah Hayward', 'role': 'CONTACT', 'email': 'leah.hayward@phri.ca'}, {'name': 'Emilie Belley-Cote, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Ingrid Copland', 'role': 'CONTACT', 'email': 'start-poaf@phri.ca', 'phone': '905-512-4940'}], 'overallOfficials': [{'name': 'William McIntyre, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Population Health Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}