Exercise-induced Cardioversion in Persistent Atrial Fibrillation

Официальное название

Exercise-induced Cardioversion in Persistent Atrial Fibrillation (ExPAF): A Feasibility Pilot Study

Обзор

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.

Подробное описание

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.

AF 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.

Although 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.

Вмешательства

• Другое Bicycle ergometer excercise
  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.
• Процедура Standard care with electrical cardioversion
  Standard care with planned electrical cardioversion without exercise intervention.

Первичные конечные точки

• Feasibility of the pilot study - Recruitment rate [Срок оценки: Day 1]
• Feasibility of the pilot study - Consent rate [Срок оценки: Day 1]
• Feasibility of the pilot study - Participant fidelity [Срок оценки: From enrollment to the end of assessments, an average of 2 months]
• Feasibility of the pilot study - Study retention [Срок оценки: Through study completion, an average of 6 months]
• Feasibility of the pilot study - Adverse events [Срок оценки: Through study completion, an average of 6 months]

Вторичные конечные точки (3)

• AF conversion to sinus rhythm [Срок оценки: Immediately after exercise or electrical conversion]
• Atrial fibrillation-related quality of life [Срок оценки: At baseline and four weeks after intervention (exercise testing and/or electrical cardioversion)]
• Overall health-related quality of life [Срок оценки: At baseline and four weeks after intervention (exercise testing and/or electrical cardioversion)]

Критерии участия

Критерии включения

• Adults (18-75 years) with persistent AF
• planned for EC
• with at least 3 weeks of therapeutic oral anticoagulation before intervention

Критерии исключения

• Unable to perform a symptom limited cycle exercise test
• Ischemic heart disease
• Heart failure
• Severe valvular disease
• Unable to speak and write Swedish language
• Unable to provide written, informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Centre for Clinical Research, Uppsala University, Västmanland County Hospital — Västerås

Публикации

• 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 31092022
• 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 2791248
• 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 495403
• 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 19383061
• 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 develope PMID 39210723
• 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 21757483
• 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 32735316
• 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 38839900

Идентификаторы

NCT: NCT07008066 · 2025-01883-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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