Optimizing Exercise Training in Prevention and Treatment of Diastolic Heart Failure
NCT ID: NCT02078947
Last Updated: 2021-11-12
Study Results
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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COMPLETED
NA
180 participants
INTERVENTIONAL
2014-07-28
2018-06-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High Intensity Exercise
Patients perform interval- type endurance exercise at high intensity
High Intensity Exercise
Moderate Continuous Exercise
Patients perform endurance exercise at moderate intensity
Moderate Continuous Exercise
Usual Care
Patients receive advice on being physically active as well as usual care
Usual Care
Interventions
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High Intensity Exercise
Moderate Continuous Exercise
Usual Care
Eligibility Criteria
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Inclusion Criteria
* At least 40 years old
* Preserved systolic function LVEF \> 50%
* Signs and symptoms of heart failure class NYHA II or III
* Diastolic dysfunction (E/é \> 15 or E/é 8-15 and NT-proBNP \> 220 pg/ml)
* Clinically stable for \>= 6 weeks
* Optimal medical treatment for \>= 6 weeks
* Written informed consent
Exclusion Criteria
* Significant pulmonary disease (FEV1 \< 50% predicted, COPD GOLD III-IV)
* Inability to exercise or conditions that may interfere with exercise intervention
* Myocardial infarction in the previous three months
* Signs of ischemia during exercise testing
* Comorbidity that may influence one- year prognosis
* Participation in another clinical trial
40 Years
ALL
No
Sponsors
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European Commission
OTHER
University of Leipzig
OTHER
University Hospital, Antwerp
OTHER
Medical University of Graz
OTHER
Norwegian University of Science and Technology
OTHER
Charite University, Berlin, Germany
OTHER
Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Martin Halle, M.D.
Role: STUDY_DIRECTOR
Technische Universität München, Munich, Germany
Martin Halle, M.D.
Role: PRINCIPAL_INVESTIGATOR
Technische Universität München, Munich, Germany
Burkert Pieske, M.D.
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Christiaan Vrints, M.D.
Role: PRINCIPAL_INVESTIGATOR
Antwerp University Hospital, Belgium
Volker Adams, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Heart Center Leipzig, Leipzig, Germany
Ulrik Wisløff, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Norwegian University of Science and Technology, Trondheim, Norway
Axel Linke, M.D.
Role: PRINCIPAL_INVESTIGATOR
Heart Center Leipzig, Leipzig, Germany
Frank Edelmann, M.D.
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Department of Cardiology, Antwerp University Hospital
Edegem, , Belgium
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Klinik für Innere Medizin/ Kardiologie, Herzzentrum Leipzig- Universitätsklinik
Leipzig, , Germany
Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München
Munich, , Germany
Countries
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References
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Gevaert AB, Witvrouwen I, Van Craenenbroeck AH, Van Laere SJ, Boen JRA, Van de Heyning CM, Belyavskiy E, Mueller S, Winzer E, Duvinage A, Edelmann F, Beckers PJ, Heidbuchel H, Wisloff U, Pieske B, Adams V, Halle M, Van Craenenbroeck EM; OptimEx-Clin Study Group. miR-181c level predicts response to exercise training in patients with heart failure and preserved ejection fraction: an analysis of the OptimEx-Clin trial. Eur J Prev Cardiol. 2021 Dec 29;28(15):1722-1733. doi: 10.1093/eurjpc/zwab151.
Mueller S, Haller B, Halle M; OptimEx-Clin Study Group. Effect of Training on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction-Reply. JAMA. 2021 Aug 24;326(8):772-773. doi: 10.1001/jama.2021.10061. No abstract available.
Gevaert AB, Bohm B, Hartmann H, Goovaerts I, Stoop T, Van De Heyning CM, Beckers PJ, Baldassarri F, Mueller S, Oberhoffer R, Duvinage A, Haykowsky MJ, Wisloff U, Adams V, Pieske B, Halle M, Van Craenenbroeck EM. Effect of Training on Vascular Function and Repair in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2023 Apr;11(4):454-464. doi: 10.1016/j.jchf.2022.12.011. Epub 2023 Mar 1.
Winzer EB, Augstein A, Schauer A, Mueller S, Fischer-Schaepmann T, Goto K, Hommel J, van Craenenbroeck EM, Wisloff U, Pieske B, Halle M, Linke A, Adams V. Impact of Different Training Modalities on Molecular Alterations in Skeletal Muscle of Patients With Heart Failure With Preserved Ejection Fraction: A Substudy of the OptimEx Trial. Circ Heart Fail. 2022 Oct;15(10):e009124. doi: 10.1161/CIRCHEARTFAILURE.121.009124. Epub 2022 Oct 6.
Gevaert AB, Mueller S, Winzer EB, Duvinage A, Van de Heyning CM, Pieske-Kraigher E, Beckers PJ, Edelmann F, Wisloff U, Pieske B, Adams V, Halle M, Van Craenenbroeck EM; OptimEx-Clin Study Group. Iron Deficiency Impacts Diastolic Function, Aerobic Exercise Capacity, and Patient Phenotyping in Heart Failure With Preserved Ejection Fraction: A Subanalysis of the OptimEx-Clin Study. Front Physiol. 2022 Feb 10;12:757268. doi: 10.3389/fphys.2021.757268. eCollection 2021.
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.
Suchy C, Massen L, Rognmo O, Van Craenenbroeck EM, Beckers P, Kraigher-Krainer E, Linke A, Adams V, Wisloff U, Pieske B, Halle M. Optimising exercise training in prevention and treatment of diastolic heart failure (OptimEx-CLIN): rationale and design of a prospective, randomised, controlled trial. Eur J Prev Cardiol. 2014 Nov;21(2 Suppl):18-25. doi: 10.1177/2047487314552764.
Related Links
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Related Info
Other Identifiers
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EU 602405-2
Identifier Type: -
Identifier Source: org_study_id