HFpEF - Heart Failure With Preserved Ejection FractionAlEX-DHFNCT06650995
AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure
A study testing Exercise training in people with HFpEF - Heart Failure With Preserved Ejection Fraction and Atrial Fibrillation, run by Technical University of Munich at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HFpEF - Heart Failure With Preserved Ejection Fraction, Atrial Fibrillation
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2027to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed heart failure with preserved ejection fraction
- Symptomatic short-persistent atrial fibrillation (diagnosis within 1 year of study inclusion)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Medicine, Division of Prevention and Sports Medicine TU Munich
Munich, 80809
Martin Halle, Prof. M.D., +49 89 289 - 24430, halle@mri.tum.de
Simon Wernhart, M.D.
About this study
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.
Read the 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.
- Being tested
- Exercise training
- Keywords
- exercise capacity, ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
exercise intervention will consist of supervised, home-based, combined training with elements of endurance, resistance and respiratory training
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group receives exercise training Receives: Other: Exercise training |
| Control Group | No intervention | This group does not receive exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta of peak oxygen consumption
Improvement of peak oxygen consumption between baseline and after 12 weeks of training
Measured: 14 weeks
Secondary outcomes (7)
Delta of mean pulmonary artery pressure and cardiac output (mPAP/CO)
Improvement of delta mPAP/CO between baseline and after 12 weeks of training
Measured: 14 weeks
Delta of pulmonary artery wedge pressure to cardiac output (PAWP/CO)
Improvement of delta PAWP/CO between baseline and after 12 weeks of training
Measured: 14 weeks
Delta of peak oxygen consumption baseline to post ablation
Improvement of peak oxygen consumption from baseline to post ablation
Measured: 2 weeks
Delta of peak oxygen consumption post ablation to the end of the study
Improvement of peak oxygen consumption from post ablation to the end of the study
Measured: 12 weeks
Delta of Kansas City Cardiomyopathy Questionnaire score
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)
Measured: 14 weeks
Delta of E/e'
Difference of E/e' between baseline and after 12 weeks of training
Measured: 14 weeks
Burden of atrial fibrillation in the groups
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)
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Feb 2027 (estimated)
- Primary completion25 Feb 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HFpEF - Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization will be done into interventional and control groups with the aid of sealed envelopes
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Wernhart, MD, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650995
- Sponsor's protocol ID
- 2024-381-S-SB
- Acronym
- AlEX-DHF
- Status last verified
- Sep 2026
- First submitted
- 18 Oct 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information can be received on reasonable request from the principal investigator
Publications
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.
PubMed 37565370Anker 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.
PubMed 37461163Houstis 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.
PubMed 28993402Jain 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.
PubMed 31507065Mueller 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.
PubMed 33560320Rattka 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.
PubMed 32449907Rattka 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.
PubMed 34379370Wernhart 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.
PubMed 36220507Wernhart 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.
PubMed 36758740