Atrial Fibrillation, HFpEF - Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
exercise capacity, ablation
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.
Interventions
OTHERExercise training
exercise intervention will consist of supervised, home-based, combined training with elements of endurance, resistance and respiratory training
Sponsors
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The principal investigator (PI) will not receive information on group allocation. Group allocation and data will be saved in a password-secured database, which will not be accessible to the PI.
Intervention model description
1:1 randomization will be done into interventional and control groups with the aid of sealed envelopes
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed heart failure with preserved ejection fraction * Symptomatic short-persistent atrial fibrillation (diagnosis within 1 year of study inclusion)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delta of peak oxygen consumption | 14 weeks | Improvement of peak oxygen consumption between baseline and after 12 weeks of training |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
Germany
Contacts
CONTACTMartin Halle, Professor
CONTACTManuel Rattka, MD
PRINCIPAL_INVESTIGATORSimon Wernhart, MD
Technical University of Munich
Outcome results
None listed