Ablation plus home exercise for diastolic heart failure and atrial fibrillation
Official title: AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure
Run by Technical University of Munich · NCT06650995 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 1 site (Munich) |
| Status | Recruiting |
| Started | February 1, 2027 |
| Main results expected | February 25, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT06650995 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.