An interventional study of Exercise training in HFpEF - Heart Failure With Preserved Ejection Fraction and Atrial Fibrillation, sponsored by Technical University of Munich. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Treatment
The investigators analyze the impact of exercise and ablation in patients with symptomatic short-persistent atrial fibrillation (Afib) and heart failure with preserved ejection fraction (HFpEF). It is hypothesized that the combination of ablation and exercise better improves peak oxygen consumption (VO2peak) through improvement of peripheral (exercise training) and central (ablation) adaptations.
Exercise intervention will contain a 12-week combined, video-based, supervised, endurance, resistance and respiratory training.
In a feasibility study the investigators analyze the impact of exercise and ablation in patients with symptomatic short-persistent atrial fibrillation and heart failure with preserved ejection fraction. Patients will be randomized into 2 groups: (1) A control group receiving ablation therapy, and (2) a group receiving ablation therapy and a combination of endurance, strength and respiratory training. The investigators will include 20 patients/group. All patients will receive a smart watch to monitor heart rate and trigger ECG recordings during symptomatic episodes. Smart watch monitoring will be done for 4 weeks. Then all patients will receive baseline examination with laboratory markers, lung function testing, echocardiography, measurement of pulse wave velocity, and screening for sleep apnea. All patients will receive simultaneous cardiopulmonary exercise testing (CPET) and exercise right heart catheterization (exRHC) followed by ablation therapy. Patients will then be randomized into a training and control group. After 2 weeks all patients will receive outpatient CPET to assess changes of VO2peak compared to baseline.
The training group will receive home-based, video-supervised exercise training with a combination of endurance, strength and respiratory training (5x/week). The control group will receive standard recommendations on physical activity. Smart watch monitoring will be continued in all groups until the end of the study. After 12 weeks of training intervention, all groups will undergo echocardiography, lung function testing, measurement of pulse wave velocity and exRHC with simultaneous CPET. All patients will receive 24h Holter monitoring at the end of the study. During exRHC lactate kinetics will be analyzed and improvement of lactate thresholds through exercise training will be determined. The primary outcome is the improvement of VO2peak in the groups. Secondary outcomes are improvements in the ratio of pulmonary capillary wedge pressure/cardiac output (PAWP/CO) and mean pulmonary artery pressure/CO (mPAP/CO). Burden of atrial fibrillation in the groups will also be assessed. All groups will receive optimal drug therapy.
The investigators expect that a combined approach of ablation and exercise training will better improve VO2peak through central (ablation) and peripheral (exercise training) adaptations.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 40 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Technical University of Munich is the lead sponsor of 320 studies on the registry; 58 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group receives exercise training
Other: Exercise training
This group does not receive exercise training
exercise intervention will consist of supervised, home-based, combined training with elements of endurance, resistance and respiratory training
Delta of peak oxygen consumption
Improvement of peak oxygen consumption between baseline and after 12 weeks of training
Time frame: 14 weeks
Delta of mean pulmonary artery pressure and cardiac output (mPAP/CO)
Improvement of delta mPAP/CO between baseline and after 12 weeks of training
Time frame: 14 weeks
Delta of pulmonary artery wedge pressure to cardiac output (PAWP/CO)
Improvement of delta PAWP/CO between baseline and after 12 weeks of training
Time frame: 14 weeks
Delta of peak oxygen consumption baseline to post ablation
Improvement of peak oxygen consumption from baseline to post ablation
Time frame: 2 weeks
Delta of peak oxygen consumption post ablation to the end of the study
Improvement of peak oxygen consumption from post ablation to the end of the study
Time frame: 12 weeks
Delta of Kansas City Cardiomyopathy Questionnaire score
Difference in the score between baseline and after 12 weeks of training (values ranging from 0-100; a higher score being associated with better quality of life in patients with heart failure)
Time frame: 14 weeks
Delta of E/e'
Difference of E/e' between baseline and after 12 weeks of training
Time frame: 14 weeks
Burden of atrial fibrillation in the groups
Difference of episodes of atrial fibrillation between the groups. Episodes of atrial fibrillation will be counted numerically with telemetry. Patients will trigger ECG recordings with their smart watch at three time points a day (8am, 2pm, 8pm) regardless of symptoms, and whenever symptoms occur (palpitations, dizziness, dyspnea, chest discomfort)
Time frame: 18 weeks
Plan to share: No — Information can be received on reasonable request from the principal investigator
Start is estimated for Feb 2027; primary completion for Feb 2027, 0 months later.
Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 0 months is below that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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