Ablation plus home exercise for diastolic heart failure and atrial fibrillation
AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure
This study tests whether adding a 12-week home-based, video-supervised endurance, strength and breathing program to ablation improves peak oxygen uptake in people with HFpEF and short‑persistent atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 1 site (Munich) |
| Trial ID | NCT06650995 on ClinicalTrials.gov |
What this trial studies
In this randomized feasibility study 40 patients with symptomatic short‑persistent AF and HFpEF will all undergo baseline labs, lung testing, echocardiography, pulse wave velocity, sleep apnea screening, simultaneous CPET and exercise right‑heart catheterization, followed by catheter ablation. After ablation participants are randomized 1:1 to a 12‑week home-based, video‑supervised combined endurance, resistance and respiratory training program (5x/week) or to standard physical activity advice. All participants receive a smartwatch for heart‑rate monitoring and ECG triggers and have repeat outpatient CPET early after ablation and again after the intervention period to compare VO2peak changes. The study is conducted at the Technical University of Munich and is designed as a small feasibility trial to test whether the combined central (ablation) and peripheral (exercise) approach improves exercise capacity.
Who should consider this trial
Good fit: Ideal candidates are people with heart failure with preserved ejection fraction and symptomatic short‑persistent atrial fibrillation diagnosed within the past year who are physically and mentally able to perform exercise testing and training and have not had prior ablation.
Not a fit: Patients with paroxysmal, long‑persistent or permanent AF, prior ablation, significant valvular disease, precapillary pulmonary hypertension at rest, unstable coronary disease, or inability to exercise are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, adding a structured home exercise program to ablation could meaningfully increase peak aerobic capacity and daily functioning for patients with HFpEF and short‑persistent AF.
How similar studies have performed: Structured exercise programs have improved VO2peak in HFpEF and ablation reduces AF burden, but combining supervised home exercise with ablation in HFpEF is a novel approach with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Munich
- Department of Medicine, Division of Prevention and Sports Medicine TU Munich — Munich, Germany (Recruiting)
Study contacts
- Principal investigator: Simon Wernhart, MD — Technical University of Munich
- Study coordinator: Martin Halle, Professor
- Email: martin.halle@mri.tum.de
- Phone: +49 8928924441
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.