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| Name | Class |
|---|---|
| European Commission | OTHER |
| University of Leipzig | OTHER |
| University Hospital, Antwerp | OTHER |
| Medical University of Graz |
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Aim of the clinical multicenter study (OptimEx-CLIN) is to assess the optimal exercise intervention in patients with Heart Failure with preserved Ejection Fraction (HFpEF; also termed diastolic heart failure) that will best improve peak oxygen uptake (Peak Vo2) and additionally diastolic function (assessed echocardiographically). The investigators hypothesize that exercise training reverses HFpEF and that intensity of exercise training is more important than duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intensity Exercise | Experimental | Patients perform interval- type endurance exercise at high intensity |
|
| Moderate Continuous Exercise | Active Comparator | Patients perform endurance exercise at moderate intensity |
|
| Usual Care | Sham Comparator | Patients receive advice on being physically active as well as usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Exercise | Behavioral |
| ||
| Moderate Continuous Exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak VO2 after three months | Change in Peak VO2 after three month intervention | Baseline and three months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in E/e' (representing diastolic filling pressure) at baseline and three months | Change in E/e' (representing diastolic filling pressure) at baseline and three months | three months |
| Change in E/e' at baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Halle, M.D. | Technische Universität München, Munich, Germany | Study Director |
| Martin Halle, M.D. | Technische Universität München, Munich, Germany | Principal Investigator |
| Burkert Pieske, M.D. | Charite University, Berlin, Germany | Principal Investigator |
| Christiaan Vrints, M.D. | Antwerp University Hospital, Belgium | Principal Investigator |
| Volker Adams, Ph.D. | Heart Center Leipzig, Leipzig, Germany | Principal Investigator |
| Ulrik Wisløff, Ph.D. | Norwegian University of Science and Technology | Principal Investigator |
| Axel Linke, M.D. | Heart Center Leipzig, Leipzig, Germany | Principal Investigator |
| Frank Edelmann, M.D. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Antwerp University Hospital | Edegem | 2650 | Belgium | |||
| Charité - Universitätsmedizin Berlin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34508569 | Result | 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. | |
| 34427605 |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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| OTHER |
| Norwegian University of Science and Technology | OTHER |
| Charite University, Berlin, Germany | OTHER |
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| Behavioral |
|
| Usual Care | Behavioral |
|
Change in E/e' at baseline and 12 months
| 12 months |
| Change in Peak VO2 at baseline and 12 months | Change in Peak VO2 at baseline and 12 months | 12 months |
| Change in NTproBNP at baseline and three months | Change in NTproBNP at baseline and three months | three months |
| Change in NTproBNP at baseline and 12 months | Change in NTproBNP at baseline and 12 months | 12 months |
| Change in health related quality of life at baseline and three months | Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and three months | three months |
| Change in health related Quality of life at baseline and 12 months | Change in HRQOL as measured by the Kansas City Cardiomyopathy Questionnaire at baseline and 12 months | 12 months |
| Change in Left Atrial Volume Index (LAVI) at baseline and three months | Change in Left Atrial Volume Index (LAVI) at baseline and three months | three months |
| Change in Left Atrial Volume Index (LAVI) at baseline and 12 months | Change in Left Atrial Volume Index (LAVI) at baseline and 12 months | 12 months |
| Change in e' medial at baseline and three months | Change in e' medial at baseline and three months | three months |
| Change in e' at baseline and 12 months | Change in e' at baseline and 12 months | 12 months |
| Change in submaximal exercise capacity at baseline and three months | submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1) | three months |
| Change in submaximal exercise capacity at baseline and 12 months | Submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1) | 12 months |
| Change in VE/VCO2 slope at baseline and three months | Change in VE/VCO2 slope at baseline and three months | three months |
| Change in VE/VCO2 slope at baseline and 12 months | Change in VE/VCO2 slope at baseline and 12 months | 12 months |
| Change in Flow Mediated Dilation (FMD) at baseline and three months | Change in Flow Mediated Dilation (FMD) at baseline and three months | three months |
| Change in Flow Mediated Dilation (FMD) at baseline and 12 months | Change in Flow Mediated Dilation (FMD) at baseline and 12 months | 12 months |
| Berlin |
| Germany |
| Klinik für Innere Medizin/ Kardiologie, Herzzentrum Leipzig- Universitätsklinik | Leipzig | 04289 | Germany |
| Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München | Munich | 80992 | Germany |
| Result |
| 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. |
| 42298662 | Derived | Dinges SM, Schwedhelm E, Baldassarri F, Haller B, Gevaert AB, Boger R, Winzer EB, Edelmann F, Wisloff U, Adams V, Pieske B, Van Craenenbroeck EM, Halle M, Hofmann SM, Mueller-Stegner S. Circulating nitric oxide pathway metabolites in heart failure with preserved ejection fraction: a sex-stratified cross-sectional analysis. Biol Sex Differ. 2026 Jun 15;17(1):120. doi: 10.1186/s13293-026-00940-7. |
| 36892488 | Derived | 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. |
| 36200450 | Derived | 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. |
| 35222057 | Derived | 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. |
| 33560320 | Derived | 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. |
| 25354950 | Derived | 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. |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |