Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID06650995

AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure

Led by Technical University of Munich · Updated on 2025-12-26

40

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of combining ablation therapy and exercise training in patients who have symptomatic short-persistent atrial fibrillation and heart failure with preserved ejection fraction (HFpEF). The goal is to see if this combination improves peak oxygen consumption (VO2peak) by enhancing both central heart function through ablation and peripheral adaptations through exercise. This is a randomized, single-blind feasibility study including 40 patients divided into two groups. Participants will be assigned either to a control group receiving ablation therapy alone or to an experimental group receiving ablation therapy plus a 12-week home-based, video-supervised exercise program. The exercise program includes endurance, resistance, and respiratory training conducted five times per week. All patients will wear a smartwatch to monitor heart rate and record ECG during symptoms for 4 weeks initially and throughout the study. Baseline and follow-up assessments include laboratory tests, lung function, echocardiography, pulse wave velocity, sleep apnea screening, cardiopulmonary exercise testing combined with exercise right heart catheterization, and 24-hour Holter monitoring. Participants will undergo evaluations before and after ablation, with the second cardiopulmonary exercise test occurring 2 weeks post-ablation and the final assessments after 12 weeks of intervention. Researchers will measure changes in VO2peak as the primary outcome, along with secondary measures such as pulmonary artery pressure ratios, heart failure questionnaire scores, and atrial fibrillation burden. Optimal drug therapy will be maintained for all, and smartwatch monitoring will continue until study completion. The total study period for each participant is approximately 14 weeks, with ongoing safety and functional assessments.

CONDITIONS

Brief Title

AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed heart failure with preserved ejection fraction
  • Symptomatic short-persistent atrial fibrillation diagnosed within 1 year of study entry
  • Adults aged 18 to 99 years
  • Able to perform exercise testing
Not Eligible

You will not qualify if you...

  • Having paroxysmal, long-persistent, or permanent atrial fibrillation
  • Clinically unstable coronary artery disease or recent acute coronary syndrome
  • Physical or mental inability to perform exercise testing
  • Prior ablation therapy
  • Precapillary pulmonary hypertension at rest
  • Presence of intracardiac shunts
  • Left ventricular ejection fraction less than 50%
  • Severe valve problems greater than grade 1 at rest

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Baseline Assessment

Duration - 1 day

Participants receive baseline examinations including laboratory markers, lung function testing, echocardiography, pulse wave velocity measurement, sleep apnea screening, cardiopulmonary exercise testing (CPET), and exercise right heart catheterization (exRHC).

1 visit (in-person)

Ablation Therapy

Duration - 1 day

Participants undergo ablation therapy after baseline assessments.

1 visit (in-person)

Post-Ablation Assessment

Duration - 2 weeks

Two weeks after ablation, participants receive an outpatient CPET to assess changes in peak oxygen consumption (VO2peak) compared to baseline.

1 visit (outpatient)

Exercise Training or Standard Care

Duration - 12 weeks

Participants are randomized into two groups: the training group receives home-based, video-supervised exercise training 5 times per week, and the control group receives standard physical activity recommendations. Smart watch monitoring continues for all participants during this period.

Weekly monitoring via smart watch; exercise training 5 times per week for training group

Final Assessment

Duration - 1 day

After 12 weeks of intervention, participants undergo echocardiography, lung function testing, pulse wave velocity measurement, exercise right heart catheterization with simultaneous CPET, and 24-hour Holter monitoring to evaluate treatment effects.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

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

Munich, Germany, 80809

Actively Recruiting

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Research Team

M

Martin Halle, Professor

M

Manuel Rattka, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Patient phenotype profiling in heart failure with preserved ejection fraction to guide therapeutic decision making. A scientific statement of the Heart Failure Association, the European Heart Rhythm Association of the European Society of Cardiology, and the European Society of Hypertension.

Stefan D Anker, Muhammad Shariq Usman, Markus S Anker...

https://pubmed.ncbi.nlm.nih.gov/37461163

Exercise Intolerance in Heart Failure With Preserved Ejection Fraction: Diagnosing and Ranking Its Causes Using Personalized O2 Pathway Analysis.

Nicholas E Houstis, Aaron S Eisman, Paul P Pappagianopoulos...

https://pubmed.ncbi.nlm.nih.gov/28993402

Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity Advice on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial.

Stephan Mueller, Ephraim B Winzer, André Duvinage...

https://pubmed.ncbi.nlm.nih.gov/33560320

Restoration of sinus rhythm by pulmonary vein isolation improves heart failure with preserved ejection fraction in atrial fibrillation patients.

Manuel Rattka, Alexander Pott, Anna Kühberger...

https://pubmed.ncbi.nlm.nih.gov/32449907

Betablockers reduce oxygen pulse increase and performance in heart failure patients with preserved ejection fraction.

Simon Wernhart, Maria Papathanasiou, Amir Abbas Mahabadi...

https://pubmed.ncbi.nlm.nih.gov/36220507

Moderate Continuous and Modified High-Intensity Interval Training in Patients With Left Ventricular Assist Devices: The Prospective Train-the-LVAD Trial.

Simon Wernhart, Marcel Oster, Martin Schulze...

https://pubmed.ncbi.nlm.nih.gov/36758740