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NCT Number: NCT06650995

AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine, Division of Prevention and Sports Medicine TU Munich

Munich, 80809, Germany

Location status: Recruiting

Location contact

Martin Halle, Prof. M.D.

CONTACT

[email protected]

+49 89 289 - 24430

Simon Wernhart, M.D.

PRINCIPAL_INVESTIGATOR

Veronika Schmid, BA

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise training

Other

exercise intervention will consist of supervised, home-based, combined training with elements of endurance, resistance and respiratory training

Primary outcomes

  1. Delta of peak oxygen consumption

    Time frame: 14 weeks

    Improvement of peak oxygen consumption between baseline and after 12 weeks of training

Secondary outcomes

  1. Delta of mean pulmonary artery pressure and cardiac output (mPAP/CO)

    Time frame: 14 weeks

    Improvement of delta mPAP/CO between baseline and after 12 weeks of training

  2. Delta of pulmonary artery wedge pressure to cardiac output (PAWP/CO)

    Time frame: 14 weeks

    Improvement of delta PAWP/CO between baseline and after 12 weeks of training

  3. Delta of peak oxygen consumption baseline to post ablation

    Time frame: 2 weeks

    Improvement of peak oxygen consumption from baseline to post ablation

  4. Delta of peak oxygen consumption post ablation to the end of the study

    Time frame: 12 weeks

    Improvement of peak oxygen consumption from post ablation to the end of the study

  5. Delta of Kansas City Cardiomyopathy Questionnaire score

    Time frame: 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)

  6. Delta of E/e'

    Time frame: 14 weeks

    Difference of E/e' between baseline and after 12 weeks of training

  7. Burden of atrial fibrillation in the groups

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Manuel Rattka, MD

CONTACT

[email protected]

+49 8928924441

Martin Halle, Professor

CONTACT

[email protected]

+49 8928924441

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Acronym: AlEX-DHF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 21, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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