AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure (AlEX-DHF)

December 18, 2025 updated by: Technical University of Munich

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Munich, Germany, 80809
        • Recruiting
        • Department of Medicine, Division of Prevention and Sports Medicine TU Munich
        • Contact:
          • Martin Halle, Prof. M.D.
          • Phone Number: +49 89 289 - 24430
          • Email: halle@mri.tum.de
        • Principal Investigator:
          • Simon Wernhart, M.D.
        • Sub-Investigator:
          • Veronika Schmid, BA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
This group receives exercise training
Other: Exercise training
exercise intervention will consist of supervised, home-based, combined training with elements of endurance, resistance and respiratory training
No Intervention: Control Group
This group does not receive exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delta of peak oxygen consumption
Time Frame: 14 weeks
Improvement of peak oxygen consumption between baseline and after 12 weeks of training
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 weeks
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
14 weeks
Delta of peak oxygen consumption baseline to post ablation
Time Frame: 2 weeks
Improvement of peak oxygen consumption from baseline to post ablation
2 weeks
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
12 weeks
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)
14 weeks
Delta of E/e'
Time Frame: 14 weeks
Difference of E/e' between baseline and after 12 weeks of training
14 weeks
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)
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Simon Wernhart, MD, Technical University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 25, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-381-S-SB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Information can be received on reasonable request from the principal investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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