AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure

NCT06650995 | Recruiting

• 1 other identifier: 2024-381-S-SB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; HFpEF - Heart Failure With Preserved Ejection Fraction

Keywords

exercise capacity; ablation

Outcome Measures

Primary Outcomes (1)

• Delta of peak oxygen consumption

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

  14 weeks

Secondary Outcomes (7)

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

  14 weeks

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

  14 weeks

• Delta of peak oxygen consumption baseline to post ablation

  2 weeks

• Delta of peak oxygen consumption post ablation to the end of the study

  12 weeks

• Delta of Kansas City Cardiomyopathy Questionnaire score

  14 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

This group receives exercise training

Other: Exercise training

Control Group

NO INTERVENTION

This group does not receive exercise training

Interventions

Exercise training OTHER

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed heart failure with preserved ejection fraction

You may not qualify if:

• 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)

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

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

Munich, 80809, Germany

RECRUITING

Related Publications (9)

• 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.

  PMID: 37565370 RESULT

• 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.

  PMID: 37461163 RESULT

• 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.

  PMID: 28993402 RESULT

• 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.

  PMID: 31507065 RESULT

• 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.

  PMID: 33560320 RESULT

• 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.

  PMID: 32449907 RESULT

• 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.

  PMID: 34379370 RESULT

• 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.

  PMID: 36220507 RESULT

• 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.

  PMID: 36758740 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Simon Wernhart, MD

  Technical University of Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Halle, Professor

CONTACT

+49 8928924441; martin.halle@mri.tum.de

Manuel Rattka, MD

CONTACT

+49 8928924441; manuel.rattka@mri.tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization will be done into interventional and control groups with the aid of sealed envelopes

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)