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Exercise training is an effective therapy for patients with heart failure with preserved ejection fraction. However, it is unclear, whether a one-year intervention has a sustainable effect beyond the active study phase. Hence, this study is a long-term follow-up of patients that were recruited for the OptimEx-Clin and Ex-DHF trials in Munich.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Former Exercise Training | Patients that were randomized to high-intensity-interval training, moderate continuous training (OptimEx-Clin) or moderate continuous training + resistance training (Ex-DHF) | ||
| Former Control | Patients that were randomized to guideline control (OptimEx-Clin) or usual care (Ex-DHF) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in peak oxygen consumption (mL/kg/min) | From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in oxygen consumption at the first ventilatory threshold (mL/kg/min) | From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years) | |
| Change in ventilation-to-carbon-dioxide production slope | From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with heart failure with preserved ejection fraction that were included in previous exercise intervention trials in Munich, Germany (OptimEx-Clin, NCT02078947; Ex-DHF, ISRCTN86879094)
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| Name | Affiliation | Role |
|---|---|---|
| Isabel Fegers-Wustrow, MD | Technical University of Munich | Principal Investigator |
| Stephan Mueller | Technical University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum rechts der Isar | Munich | 80992 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33560320 | Background | 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 |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Change in E/e' | From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years) |
| Change in left ventricular ejection fraction (%) | From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years) |
| Change in quality of life | Changes in Short Form-36 questionnaire (patients from Ex-DHF, scale 0-100, higher is better) and Kansas City Cardiomyopathy Questionaire - Quality of Life domain (patients from OptimEx, scale 0-100, higher is better) will be combined using the standardized mean difference | From Baseline Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 4.6 to 9.1 years) |
| Time to first cardiovascular event | From Last Visit of Ex-DHF / OptimEx to Long-Term Follow-Up (between 3.3 to 8.2 years) |
| Background |
| 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. |
| 28516519 | Background | Edelmann F, Bobenko A, Gelbrich G, Hasenfuss G, Herrmann-Lingen C, Duvinage A, Schwarz S, Mende M, Prettin C, Trippel T, Lindhorst R, Morris D, Pieske-Kraigher E, Nolte K, Dungen HD, Wachter R, Halle M, Pieske B. Exercise training in Diastolic Heart Failure (Ex-DHF): rationale and design of a multicentre, prospective, randomized, controlled, parallel group trial. Eur J Heart Fail. 2017 Aug;19(8):1067-1074. doi: 10.1002/ejhf.862. Epub 2017 May 17. |