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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; 19(8):1067-1074EJ

Abstract

Heart failure with preserved ejection fraction (HFpEF) is a common disease with high incidence and increasing prevalence. Patients suffer from functional limitation, poor health-related quality of life, and reduced prognosis. A pilot study in a smaller group of HFpEF patients showed that structured, supervised exercise training (ET) improves maximal exercise capacity, diastolic function, and physical quality of life. However, the long-term effects of ET on patient-related outcomes remain unclear in HFpEF. The primary objective of the Exercise training in Diastolic Heart Failure (Ex-DHF) trial is to investigate whether a 12 month supervised ET can improve a clinically meaningful composite outcome score in HFpEF patients. Components of the outcome score are all-cause mortality, hospitalizations, NYHA functional class, global self-rated health, maximal exercise capacity, and diastolic function. After undergoing baseline assessments to determine whether ET can be performed safely, 320 patients at 11 trial sites with stable HFpEF are randomized 1:1 to supervised ET in addition to usual care or to usual care alone. Patients randomized to ET perform supervised endurance/resistance ET (3 times/week at a certified training centre) for 12 months. At baseline and during follow-up, anthropometry, echocardiography, cardiopulmonary exercise testing, and health-related quality of life evaluation are performed. Blood samples are collected to examine various biomarkers. Overall physical activity, training sessions, and adherence are monitored and documented throughout the study using patient diaries, heart rate monitors, and accelerometers. The Ex-DHF trial is the first multicentre trial to assess the long-term effects of a supervised ET programme on different outcome measures in patients with HFpEF.

Authors+Show Affiliations

Charité Universitätsmedizin Berlin, Department of Cardiology, Berlin, Germany. DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany. University of Göttingen Medical Centre, Department of Cardiology and Pneumology, Göttingen, Germany. DZHK (German Centre for Cardiovascular Research), Partner Site Göttingen, Göttingen, Germany.Charité Universitätsmedizin Berlin, Department of Cardiology, Berlin, Germany. DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.University of Würzburg, Institute for Clinical Epidemiology and Biometry, Würzburg, Germany. University Hospital Würzburg, Clinical Trial Centre, Würzburg, Germany.University of Göttingen Medical Centre, Department of Cardiology and Pneumology, Göttingen, Germany. DZHK (German Centre for Cardiovascular Research), Partner Site Göttingen, Göttingen, Germany.DZHK (German Centre for Cardiovascular Research), Partner Site Göttingen, Göttingen, Germany. University of Göttingen Medical Centre, Department of Psychosomatic Medicine and Psychotherapy, Göttingen, Germany.Technische Universität München, Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany.Technische Universität München, Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany.University of Leipzig, Clinical Trial Centre (KKS), Leipzig, Germany.University of Leipzig, Clinical Trial Centre (KKS), Leipzig, Germany.Charité Universitätsmedizin Berlin, Department of Cardiology, Berlin, Germany. DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.Charité Universitätsmedizin Berlin, Department of Cardiology, Berlin, Germany. DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.Charité Universitätsmedizin Berlin, Department of Cardiology, Berlin, Germany.Charité Universitätsmedizin Berlin, Department of Cardiology, Berlin, Germany.University of Göttingen Medical Centre, Department of Cardiology and Pneumology, Göttingen, Germany. DZHK (German Centre for Cardiovascular Research), Partner Site Göttingen, Göttingen, Germany.Charité Universitätsmedizin Berlin, Department of Cardiology, Berlin, Germany. DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.University of Göttingen Medical Centre, Department of Cardiology and Pneumology, Göttingen, Germany. DZHK (German Centre for Cardiovascular Research), Partner Site Göttingen, Göttingen, Germany.Technische Universität München, Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany. DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.Charité Universitätsmedizin Berlin, Department of Cardiology, Berlin, Germany. DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany. Deutsches Herzzentrum Berlin (DHZB), Department of Cardiology, Berlin, Germany.

Pub Type(s)

Journal Article
Review
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28516519

Citation

Edelmann, Frank, et al. "Exercise Training in Diastolic Heart Failure (Ex-DHF): Rationale and Design of a Multicentre, Prospective, Randomized, Controlled, Parallel Group Trial." European Journal of Heart Failure, vol. 19, no. 8, 2017, pp. 1067-1074.
Edelmann F, Bobenko A, Gelbrich G, et al. 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;19(8):1067-1074.
Edelmann, F., Bobenko, A., Gelbrich, G., Hasenfuss, G., Herrmann-Lingen, C., Duvinage, A., ... Pieske, B. (2017). Exercise training in Diastolic Heart Failure (Ex-DHF): rationale and design of a multicentre, prospective, randomized, controlled, parallel group trial. European Journal of Heart Failure, 19(8), pp. 1067-1074. doi:10.1002/ejhf.862.
Edelmann F, et al. 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;19(8):1067-1074. PubMed PMID: 28516519.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Exercise training in Diastolic Heart Failure (Ex-DHF): rationale and design of a multicentre, prospective, randomized, controlled, parallel group trial. AU - Edelmann,Frank, AU - Bobenko,Anna, AU - Gelbrich,Götz, AU - Hasenfuss,Gerd, AU - Herrmann-Lingen,Christoph, AU - Duvinage,André, AU - Schwarz,Silja, AU - Mende,Meinhard, AU - Prettin,Christiane, AU - Trippel,Tobias, AU - Lindhorst,Ruhdja, AU - Morris,Daniel, AU - Pieske-Kraigher,Elisabeth, AU - Nolte,Kathleen, AU - Düngen,Hans-Dirk, AU - Wachter,Rolf, AU - Halle,Martin, AU - Pieske,Burkert, Y1 - 2017/05/17/ PY - 2016/12/22/received PY - 2017/03/13/revised PY - 2017/03/30/accepted PY - 2017/5/19/pubmed PY - 2018/6/12/medline PY - 2017/5/19/entrez KW - Diastolic dysfunction KW - Exercise intervention KW - Heart failure KW - Heart failure with preserved ejection fraction KW - Supervised exercise training SP - 1067 EP - 1074 JF - European journal of heart failure JO - Eur. J. Heart Fail. VL - 19 IS - 8 N2 - Heart failure with preserved ejection fraction (HFpEF) is a common disease with high incidence and increasing prevalence. Patients suffer from functional limitation, poor health-related quality of life, and reduced prognosis. A pilot study in a smaller group of HFpEF patients showed that structured, supervised exercise training (ET) improves maximal exercise capacity, diastolic function, and physical quality of life. However, the long-term effects of ET on patient-related outcomes remain unclear in HFpEF. The primary objective of the Exercise training in Diastolic Heart Failure (Ex-DHF) trial is to investigate whether a 12 month supervised ET can improve a clinically meaningful composite outcome score in HFpEF patients. Components of the outcome score are all-cause mortality, hospitalizations, NYHA functional class, global self-rated health, maximal exercise capacity, and diastolic function. After undergoing baseline assessments to determine whether ET can be performed safely, 320 patients at 11 trial sites with stable HFpEF are randomized 1:1 to supervised ET in addition to usual care or to usual care alone. Patients randomized to ET perform supervised endurance/resistance ET (3 times/week at a certified training centre) for 12 months. At baseline and during follow-up, anthropometry, echocardiography, cardiopulmonary exercise testing, and health-related quality of life evaluation are performed. Blood samples are collected to examine various biomarkers. Overall physical activity, training sessions, and adherence are monitored and documented throughout the study using patient diaries, heart rate monitors, and accelerometers. The Ex-DHF trial is the first multicentre trial to assess the long-term effects of a supervised ET programme on different outcome measures in patients with HFpEF. SN - 1879-0844 UR - https://www.unboundmedicine.com/medline/citation/28516519/Exercise_training_in_Diastolic_Heart_Failure__Ex_DHF_:_rationale_and_design_of_a_multicentre_prospective_randomized_controlled_parallel_group_trial_ L2 - https://doi.org/10.1002/ejhf.862 DB - PRIME DP - Unbound Medicine ER -