AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure
- Conditions
- HFpEF - Heart Failure With Preserved Ejection FractionAtrial Fibrillation
- Registration Number
- NCT06650995
- Lead Sponsor
- Technical University of Munich
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Diagnosed heart failure with preserved ejection fraction
- Symptomatic short-persistent atrial fibrillation (diagnosis within 1 year of study inclusion)
- Paroxysmal, long-persistent or permanent atrial fibrillation
- Clinically unstable coronary artery disease or acute coronary syndrome
- Physical and/or mental inability to perform exercise testing
- Prior ablation therapy
- Precapillary pulmonary hypertension at rest
- Intracardiac shunts
- Left ventricular ejection fraction <50%
- High-degree valve insufficiency or stenosis (greater than grade 1 at rest)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Delta of peak oxygen consumption 14 weeks Improvement of peak oxygen consumption between baseline and after 12 weeks of training
- Secondary Outcome Measures
Name Time Method Burden of atrial fibrillation in the groups 18 weeks 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)
Delta of mean pulmonary artery pressure and cardiac output (mPAP/CO) 14 weeks Improvement of delta mPAP/CO between baseline and after 12 weeks of training
Delta of pulmonary artery wedge pressure to cardiac output (PAWP/CO) 14 weeks Improvement of delta PAWP/CO between baseline and after 12 weeks of training
Delta of peak oxygen consumption baseline to post ablation 2 weeks Improvement of peak oxygen consumption from baseline to post ablation
Delta of peak oxygen consumption post ablation to the end of the study 12 weeks Improvement of peak oxygen consumption from post ablation to the end of the study
Delta of Kansas City Cardiomyopathy Questionnaire score 14 weeks 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)
Delta of E/e' 14 weeks Difference of E/e' between baseline and after 12 weeks of training
Trial Locations
- Locations (1)
Department of Medicine, Division of Prevention and Sports Medicine TU Munich
🇩🇪Munich, Germany