Centre for Clinical Research, Uppsala University, Västmanland County Hospital
Västerås, SE-72189, Sweden
NCT Number: NCT07008066
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Västerås, SE-72189, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Standard care with planned electrical cardioversion without exercise intervention.
Time frame: Day 1
Number of patients asked to participate in the study
Time frame: Day 1
Number of patients giving written consent to participate in the study
Time frame: From enrollment to the end of assessments, an average of 2 months
Ability of participants to comply with the intervention protocol.
Time frame: Through study completion, an average of 6 months
Participants dropout rates.
Time frame: Through study completion, an average of 6 months
Side effects and adverse events during the study
Time frame: Immediately after exercise or electrical conversion
Rate of AF conversion to sinus rhythm immediately after intervention
Time frame: At baseline and four weeks after intervention (exercise testing and/or electrical cardioversion)
Atrial fibrillation-related quality of life, as measured by the AFEQT score.
Time frame: At baseline and four weeks after intervention (exercise testing and/or electrical cardioversion)
Overall health-related quality of life, as measured by the EQ VAS (0-100) scale (from EQ5D-5L).
Contact information is provided by the study sponsor or research team.
Uppsala University
Other
Exercise-induced Cardioversion in Persistent Atrial Fibrillation (ExPAF): A Feasibility Pilot Study
Acronym: ExPAF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07711327
Arrhythmias, Cardiac, Atrial Fibrillation
Duarte, California, United States
View Trial DetailsNCT07648329
Arrhythmias, Cardiac, Atrial Cardiomyopathy
Dijon, France
View Trial DetailsNCT07395089
Arrhythmia, Arrhythmias, Cardiac
Paris, Île-de-France Region, France
View Trial DetailsNCT07359872
Ablation of Atrial Fibrillation, Arrhythmia
View Trial Details