Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-01-17 @ 1:48 AM
Study NCT ID:
NCT07008066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-06
First Post:
2025-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise-induced Cardioversion in Persistent Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'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': 'D059039', 'term': 'Standard of Care'}, {'id': 'D004554', 'term': 'Electric Countershock'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-05-28', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the pilot study - Recruitment rate', 'timeFrame': 'Day 1', 'description': 'Number of patients asked to participate in the study'}, {'measure': 'Feasibility of the pilot study - Consent rate', 'timeFrame': 'Day 1', 'description': 'Number of patients giving written consent to participate in the study'}, {'measure': 'Feasibility of the pilot study - Participant fidelity', 'timeFrame': 'From enrollment to the end of assessments, an average of 2 months', 'description': 'Ability of participants to comply with the intervention protocol.'}, {'measure': 'Feasibility of the pilot study - Study retention', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Participants dropout rates.'}, {'measure': 'Feasibility of the pilot study - Adverse events', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Side effects and adverse events during the study'}], 'secondaryOutcomes': [{'measure': 'AF conversion to sinus rhythm', 'timeFrame': 'Immediately after exercise or electrical conversion', 'description': 'Rate of AF conversion to sinus rhythm immediately after intervention'}, {'measure': 'Atrial fibrillation-related quality of life', 'timeFrame': 'At baseline and four weeks after intervention (exercise testing and/or electrical cardioversion)', 'description': 'Atrial fibrillation-related quality of life, as measured by the AFEQT score.'}, {'measure': 'Overall health-related quality of life', 'timeFrame': 'At baseline and four weeks after intervention (exercise testing and/or electrical cardioversion)', 'description': 'Overall health-related quality of life, as measured by the EQ VAS (0-100) scale (from EQ5D-5L).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise Testing', 'Persistent Atrial Fibrillation', 'Electrical Cardioversion', 'Arrhythmia'], 'conditions': ['Atrial Fibrillation (AF)']}, 'referencesModule': {'references': [{'pmid': '31092022', 'type': 'BACKGROUND', 'citation': "Holmes DN, Piccini JP, Allen LA, Fonarow GC, Gersh BJ, Kowey PR, O'Brien EC, Reiffel JA, Naccarelli GV, Ezekowitz MD, Chan PS, Singer DE, Spertus JA, Peterson ED, Thomas L. Defining Clinically Important Difference in the Atrial Fibrillation Effect on Quality-of-Life Score. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005358. doi: 10.1161/CIRCOUTCOMES.118.005358."}, {'pmid': '2791248', 'type': 'BACKGROUND', 'citation': 'Gibbons L, Blair SN, Kohl HW, Cooper K. The safety of maximal exercise testing. Circulation. 1989 Oct;80(4):846-52. doi: 10.1161/01.cir.80.4.846.'}, {'pmid': '495403', 'type': 'BACKGROUND', 'citation': 'Atterhog JH, Jonsson B, Samuelsson R. Exercise testing: a prospective study of complication rates. Am Heart J. 1979 Nov;98(5):572-9. doi: 10.1016/0002-8703(79)90282-5.'}, {'pmid': '19383061', 'type': 'BACKGROUND', 'citation': 'Gates P, Al-Daher S, Ridley D, Black A. Could exercise be a new strategy to revert some patients with atrial fibrillation? Intern Med J. 2010 Jan;40(1):57-60. doi: 10.1111/j.1445-5994.2009.01940.x.'}, {'pmid': '39210723', 'type': 'BACKGROUND', 'citation': 'Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, Jaarsma T, Lettino M, Lochen ML, Lumbers RT, Maesen B, Molgaard I, Rosano GMC, Sanders P, Schnabel RB, Suwalski P, Svennberg E, Tamargo J, Tica O, Traykov V, Tzeis S, Kotecha D; ESC Scientific Document Group. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024 Sep 29;45(36):3314-3414. doi: 10.1093/eurheartj/ehae176. No abstract available.'}, {'pmid': '21757483', 'type': 'BACKGROUND', 'citation': 'Wolowacz SE, Samuel M, Brennan VK, Jasso-Mosqueda JG, Van Gelder IC. The cost of illness of atrial fibrillation: a systematic review of the recent literature. Europace. 2011 Oct;13(10):1375-85. doi: 10.1093/europace/eur194. Epub 2011 Jul 14.'}, {'pmid': '32735316', 'type': 'BACKGROUND', 'citation': 'Dai H, Zhang Q, Much AA, Maor E, Segev A, Beinart R, Adawi S, Lu Y, Bragazzi NL, Wu J. Global, regional, and national prevalence, incidence, mortality, and risk factors for atrial fibrillation, 1990-2017: results from the Global Burden of Disease Study 2017. Eur Heart J Qual Care Clin Outcomes. 2021 Oct 28;7(6):574-582. doi: 10.1093/ehjqcco/qcaa061.'}, {'pmid': '38839900', 'type': 'BACKGROUND', 'citation': 'Mobley AR, Subramanian A, Champsi A, Wang X, Myles P, McGreavy P, Bunting KV, Shukla D, Nirantharakumar K, Kotecha D. Thromboembolic events and vascular dementia in patients with atrial fibrillation and low apparent stroke risk. Nat Med. 2024 Aug;30(8):2288-2294. doi: 10.1038/s41591-024-03049-9. Epub 2024 Jun 5.'}, {'pmid': '35061884', 'type': 'BACKGROUND', 'citation': 'Koh YH, Lew LZW, Franke KB, Elliott AD, Lau DH, Thiyagarajah A, Linz D, Arstall M, Tully PJ, Baune BT, Munawar DA, Mahajan R. Predictive role of atrial fibrillation in cognitive decline: a systematic review and meta-analysis of 2.8 million individuals. Europace. 2022 Sep 1;24(8):1229-1239. doi: 10.1093/europace/euac003.'}, {'pmid': '29370229', 'type': 'BACKGROUND', 'citation': 'Bassand JP, Accetta G, Al Mahmeed W, Corbalan R, Eikelboom J, Fitzmaurice DA, Fox KAA, Gao H, Goldhaber SZ, Goto S, Haas S, Kayani G, Pieper K, Turpie AGG, van Eickels M, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Risk factors for death, stroke, and bleeding in 28,628 patients from the GARFIELD-AF registry: Rationale for comprehensive management of atrial fibrillation. PLoS One. 2018 Jan 25;13(1):e0191592. doi: 10.1371/journal.pone.0191592. eCollection 2018.'}, {'pmid': '28617620', 'type': 'BACKGROUND', 'citation': 'Ruddox V, Sandven I, Munkhaugen J, Skattebu J, Edvardsen T, Otterstad JE. Atrial fibrillation and the risk for myocardial infarction, all-cause mortality and heart failure: A systematic review and meta-analysis. Eur J Prev Cardiol. 2017 Sep;24(14):1555-1566. doi: 10.1177/2047487317715769. Epub 2017 Jun 15.'}, {'pmid': '27599725', 'type': 'BACKGROUND', 'citation': 'Odutayo A, Wong CX, Hsiao AJ, Hopewell S, Altman DG, Emdin CA. Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ. 2016 Sep 6;354:i4482. doi: 10.1136/bmj.i4482.'}, {'pmid': '23900699', 'type': 'BACKGROUND', 'citation': 'Krijthe BP, Kunst A, Benjamin EJ, Lip GY, Franco OH, Hofman A, Witteman JC, Stricker BH, Heeringa J. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J. 2013 Sep;34(35):2746-51. doi: 10.1093/eurheartj/eht280. Epub 2013 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to to evaluate the feasibility of conducting a larger randomized controlled trial (RCT) to assess whether an exercise stress test on an ergometer bicycle could induce sinus rhythm in patients with persistent AF scheduled for electrical cardioversion and if this intervention (regardless of rhythm conversion) could improve health-related quality of life in these patients.', 'detailedDescription': 'Atrial fibrillation (AF) is one of the most common heart rhythm disorders worldwide. The estimated prevalence of AF in Europe is approximately 2% in the general population and increases with age, reaching 16-24% in individuals aged \\> 85 years. AF is significantly associated with an increased risk of heart failure, ischemic stroke, cognitive impairment, vascular dementia, and death. Aside from patient suffering, AF is a large economic burden for the healthcare system, where hospitalization is the major driver, accounting for 50-70% of the annual direct costs. Management of patients with AF is multifaceted. The main components include comorbidity and risk factor management (targeting hypertension, diabetes, heart failure), avoidance of stroke and thromboembolism, and reduction of symptoms through rate and rhythm control.\n\nAF episodes may terminate spontaneously, and if they do so within seven days, they are classified as paroxysmal AF. Persistent AF is defined as AF episodes that are not self-terminating. Rhythm control, which involves restoring and maintaining sinus rhythm, is an important part of the management of patients with atrial fibrillation, where the main reason is to reduce symptoms of AF. One alternative treatment is electrical cardioversion (EC), which involves delivering low-energy shocks to the heart in a sedated patient to restore a normal sinus rhythm. A poorly tested alternative to EC in cardioversion is to physically increase the heart rate. In a small observational study, Gates et al. included 18 patients with AF scheduled for EC. The patients underwent a treadmill exercise test, and five (27.8%) converted to sinus rhythm during exercise. None of the patients who failed to convert to sinus rhythm with exercise did so spontaneously before electrical conversion 3 hours to 7 months later. Exercise tests are considered safe when contraindications are adhered to, termination criteria are observed, and appropriately trained personnel administer the tests.\n\nAlthough EC is effective, it involves hospitalization, anesthesia, and the associated costs and risks. If exercise testing proves to be effective for converting AF to sinus rhythm, it could improve arrhythmia management by offering a non-invasive, cost-effective alternative that empowers patients to manage their condition through home-based programs. This approach not only would reduce hospital dependence and healthcare costs but also enhance cardiovascular fitness and overall quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18-75 years) with persistent AF\n* planned for EC\n* with at least 3 weeks of therapeutic oral anticoagulation before intervention\n\nExclusion Criteria:\n\n* Unable to perform a symptom limited cycle exercise test\n* Ischemic heart disease\n* Heart failure\n* Severe valvular disease\n* Unable to speak and write Swedish language\n* Unable to provide written, informed consent'}, 'identificationModule': {'nctId': 'NCT07008066', 'acronym': 'ExPAF', 'briefTitle': 'Exercise-induced Cardioversion in Persistent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Exercise-induced Cardioversion in Persistent Atrial Fibrillation (ExPAF): A Feasibility Pilot Study', 'orgStudyIdInfo': {'id': '2025-01883-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'Patients will undergo a symptom-limited ergometer cycling test under medical supervision. If the atrial fibrillation is not converted to sinus rhythm during the exercise test, the patients will be electrically converted.', 'interventionNames': ['Other: Bicycle ergometer excercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Standard care with planned electrical cardioversion without exercise intervention.', 'interventionNames': ['Procedure: Standard care with electrical cardioversion']}], 'interventions': [{'name': 'Bicycle ergometer excercise', 'type': 'OTHER', 'description': 'Patients will undergo a symptom-limited ergometer cycling test under medical supervision. If the atrial fibrillation is not converted to sinus rhythm during the exercise test, the patients will be electrically converted.', 'armGroupLabels': ['Exercise group']}, {'name': 'Standard care with electrical cardioversion', 'type': 'PROCEDURE', 'description': 'Standard care with planned electrical cardioversion without exercise intervention.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-72189', 'city': 'Västerås', 'country': 'Sweden', 'facility': 'Centre for Clinical Research, Uppsala University, Västmanland County Hospital', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'centralContacts': [{'name': 'Pär Hedberg, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'par.hedberg@uu.se; par.o.hedberg@regionvastmanland.se', 'phone': '+46 21 175177'}, {'name': 'Elin Canelhas, M.D.', 'role': 'CONTACT', 'email': 'elin.canelhas@regionvastmanland.se'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Västmanland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Senior Consultant', 'investigatorFullName': 'Pär Hedberg', 'investigatorAffiliation': 'Uppsala University'}}}}