Exercise-induced Cardioversion in Persistent Atrial Fibrillation

NCT07008066 | Not Yet Recruiting

• 1 other identifier: 2025-01883-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Exercise Testing; Persistent Atrial Fibrillation; Electrical Cardioversion; Arrhythmia

Outcome Measures

Primary Outcomes (5)

• Feasibility of the pilot study - Recruitment rate

  Number of patients asked to participate in the study

  Day 1

• Feasibility of the pilot study - Consent rate

  Number of patients giving written consent to participate in the study

  Day 1

• Feasibility of the pilot study - Participant fidelity

  Ability of participants to comply with the intervention protocol.

  From enrollment to the end of assessments, an average of 2 months

• Feasibility of the pilot study - Study retention

  Participants dropout rates.

  Through study completion, an average of 6 months

• Feasibility of the pilot study - Adverse events

  Side effects and adverse events during the study

  Through study completion, an average of 6 months

Secondary Outcomes (3)

• AF conversion to sinus rhythm

  Immediately after exercise or electrical conversion

• Atrial fibrillation-related quality of life

  At baseline and four weeks after intervention (exercise testing and/or electrical cardioversion)

• Overall health-related quality of life

  At baseline and four weeks after intervention (exercise testing and/or electrical cardioversion)

Study Arms (2)

Exercise group

EXPERIMENTAL

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.

Other: Bicycle ergometer excercise

Control group

ACTIVE COMPARATOR

Standard care with planned electrical cardioversion without exercise intervention.

Procedure: Standard care with electrical cardioversion

Interventions

Bicycle ergometer excercise OTHER

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.

Exercise group

Standard care with electrical cardioversion PROCEDURE

Standard care with planned electrical cardioversion without exercise intervention.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• Region Västmanland: collaborator

Study Sites (1)

Centre for Clinical Research, Uppsala University, Västmanland County Hospital

Västerås, SE-72189, Sweden

Location

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 39210723 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 35061884 BACKGROUND

• 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: 29370229 BACKGROUND

• 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: 28617620 BACKGROUND

• 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: 27599725 BACKGROUND

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  PMID: 23900699 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Standard of Care; Electric Countershock

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Electric Stimulation Therapy; Therapeutics

Central Study Contacts

Pär Hedberg, M.D., Ph.D.

CONTACT

+46 21 175177; par.hedberg@uu.se; par.o.hedberg@regionvastmanland.se

Elin Canelhas, M.D.

CONTACT

elin.canelhas@regionvastmanland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Senior Consultant

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: June 6, 2025
• Study Start: September 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-05

Locations

SE (1)