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ID06650995

Study of Ablation and Supervised Exercise Training in Adults with Heart Failure with Preserved Ejection Fraction and Symptomatic Short-Persistent Atrial Fibrillation

Led by Technical University of Munich · Updated on 2025-12-26

40

Participants Needed

1

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of combining ablation therapy and exercise training in patients who have symptomatic short-persistent atrial fibrillation and heart failure with preserved ejection fraction HFpEF. The goal is to see if this combination improves peak oxygen consumption VO2peak by enhancing both central heart function through ablation and peripheral adaptations through exercise. This is a randomized, single-blind feasibility study including 40 patients divided into two groups. Participants will be assigned either to a control group receiving ablation therapy alone or to an experimental group receiving ablation therapy plus a 12-week home-based, video-supervised exercise program. The exercise program includes endurance, resistance, and respiratory training conducted five times per week. All patients will wear a smartwatch to monitor heart rate and record ECG during symptoms for 4 weeks initially and throughout the study. Baseline and follow-up assessments include laboratory tests, lung function, echocardiography, pulse wave velocity, sleep apnea screening, cardiopulmonary exercise testing combined with exercise right heart catheterization, and 24-hour Holter monitoring. Participants will undergo evaluations before and after ablation, with the second cardiopulmonary exercise test occurring 2 weeks post-ablation and the final assessments after 12 weeks of intervention. Researchers will measure changes in VO2peak as the primary outcome, along with secondary measures such as pulmonary artery pressure ratios, heart failure questionnaire scores, and atrial fibrillation burden. Optimal drug therapy will be maintained for all, and smartwatch monitoring will continue until study completion. The total study period for each participant is approximately 14 weeks, with ongoing safety and functional assessments.

CONDITIONS

Brief Title

AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure

Research Team

M

Martin Halle, Professor

M

Manuel Rattka, MD

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