Exercise training in Diastolic Heart Failure (Ex-DHF): rationale and design of a multicentre, prospective, randomized, controlled, parallel group trial.

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, Düngen HD, Wachter R, Halle M, Pieske B.

Eur J Heart Fail. 2017 Aug;19(8):1067-1074. doi: 10.1002/ejhf.862. Epub 2017 May

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.