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AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure

NCT ID: NCT06650995

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HFpEF - Heart Failure With Preserved Ejection Fraction Atrial Fibrillation

Keywords

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ablation exercise capacity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization will be done into interventional and control groups with the aid of sealed envelopes
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The principal investigator (PI) will not receive information on group allocation. Group allocation and data will be saved in a password-secured database, which will not be accessible to the PI.

Study Groups

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Intervention Group

This group receives exercise training

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

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

Control Group

This group does not receive exercise training

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise training

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon Wernhart, MD

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Locations

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

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Martin Halle, Professor

Role: CONTACT

Phone: +49 8928924441

Email: [email protected]

Manuel Rattka, MD

Role: CONTACT

Phone: +49 8928924441

Email: [email protected]

Facility Contacts

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Martin Halle, Prof. M.D.

Role: primary

References

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Wernhart S, Goertz A, Hedderich J, Papathanasiou M, Hoffmann J, Rassaf T, Luedike P. Diastolic exercise stress testing in heart failure with preserved ejection fraction: The DEST-HF study. Eur J Heart Fail. 2023 Oct;25(10):1768-1780. doi: 10.1002/ejhf.2995. Epub 2023 Aug 24.

Reference Type RESULT
PMID: 37565370 (View on PubMed)

Anker SD, Usman MS, Anker MS, Butler J, Bohm M, Abraham WT, Adamo M, Chopra VK, Cicoira M, Cosentino F, Filippatos G, Jankowska EA, Lund LH, Moura B, Mullens W, Pieske B, Ponikowski P, Gonzalez-Juanatey JR, Rakisheva A, Savarese G, Seferovic P, Teerlink JR, Tschope C, Volterrani M, von Haehling S, Zhang J, Zhang Y, Bauersachs J, Landmesser U, Zieroth S, Tsioufis K, Bayes-Genis A, Chioncel O, Andreotti F, Agabiti-Rosei E, Merino JL, Metra M, Coats AJS, Rosano GMC. 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. Eur J Heart Fail. 2023 Jul;25(7):936-955. doi: 10.1002/ejhf.2894. Epub 2023 Jul 17.

Reference Type RESULT
PMID: 37461163 (View on PubMed)

Houstis NE, Eisman AS, Pappagianopoulos PP, Wooster L, Bailey CS, Wagner PD, Lewis GD. Exercise Intolerance in Heart Failure With Preserved Ejection Fraction: Diagnosing and Ranking Its Causes Using Personalized O2 Pathway Analysis. Circulation. 2018 Jan 9;137(2):148-161. doi: 10.1161/CIRCULATIONAHA.117.029058. Epub 2017 Oct 9.

Reference Type RESULT
PMID: 28993402 (View on PubMed)

Jain CC, Borlaug BA. Hemodynamic assessment in heart failure. Catheter Cardiovasc Interv. 2020 Feb 15;95(3):420-428. doi: 10.1002/ccd.28490. Epub 2019 Sep 10.

Reference Type RESULT
PMID: 31507065 (View on PubMed)

Mueller S, Winzer EB, Duvinage A, Gevaert AB, Edelmann F, Haller B, Pieske-Kraigher E, Beckers P, Bobenko A, Hommel J, Van de Heyning CM, Esefeld K, von Korn P, Christle JW, Haykowsky MJ, Linke A, Wisloff U, Adams V, Pieske B, van Craenenbroeck EM, Halle M; OptimEx-Clin Study Group. 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. JAMA. 2021 Feb 9;325(6):542-551. doi: 10.1001/jama.2020.26812.

Reference Type RESULT
PMID: 33560320 (View on PubMed)

Rattka M, Pott A, Kuhberger A, Weinmann K, Scharnbeck D, Stephan T, Baumhardt M, Bothner C, Iturbe Orbe M, Rottbauer W, Dahme T. Restoration of sinus rhythm by pulmonary vein isolation improves heart failure with preserved ejection fraction in atrial fibrillation patients. Europace. 2020 Sep 1;22(9):1328-1336. doi: 10.1093/europace/euaa101.

Reference Type RESULT
PMID: 32449907 (View on PubMed)

Rattka M, Kuhberger A, Pott A, Stephan T, Weinmann K, Baumhardt M, Aktolga D, Teumer Y, Bothner C, Scharnbeck D, Rottbauer W, Dahme T. Catheter ablation for atrial fibrillation in HFpEF patients-A propensity-score-matched analysis. J Cardiovasc Electrophysiol. 2021 Sep;32(9):2357-2367. doi: 10.1111/jce.15200. Epub 2021 Aug 18.

Reference Type RESULT
PMID: 34379370 (View on PubMed)

Wernhart S, Papathanasiou M, Mahabadi AA, Rassaf T, Luedike P. Betablockers reduce oxygen pulse increase and performance in heart failure patients with preserved ejection fraction. Int J Cardiol. 2023 Jan 1;370:309-318. doi: 10.1016/j.ijcard.2022.10.009. Epub 2022 Oct 8.

Reference Type RESULT
PMID: 36220507 (View on PubMed)

Wernhart S, Oster M, Schulze M, Papathanasiou M, Ruhparwar A, Rassaf T, Luedike P. Moderate Continuous and Modified High-Intensity Interval Training in Patients With Left Ventricular Assist Devices: The Prospective Train-the-LVAD Trial. J Card Fail. 2023 May;29(5):841-848. doi: 10.1016/j.cardfail.2023.01.007. Epub 2023 Feb 8.

Reference Type RESULT
PMID: 36758740 (View on PubMed)

Other Identifiers

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2024-381-S-SB

Identifier Type: -

Identifier Source: org_study_id