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. 2014 Apr 27;2014(4):CD003331. doi: 10.1002/14651858.CD003331.pub4

ISRCTN86879094

Trial name or title Exercise Training in Diastolic Heart Failure: a Prospective, Randomized, Controlled Study to Determine the Effects of Exercise Training in Patients with Heart Failure and Preserved Ejection Fraction (Ex‐DHF)
Methods RCT
Participants Stable symptomatic HF with preserved ejection fraction (diagnosis according to criteria of the European Society of Cardiology (Paulus 2007))
Interventions Experimental intervention: individually prescribed, supervised, combined endurance/strength training for 12 months (≥ 3 times/week) Control intervention: usual care
Outcomes Primary

  1. Combined outcome score (modified 'Packer score', Packer 2001). This combined score classifies participants as: 1 (worsened), 0 (unchanged) or +1 (improved)


Secondary

  1. Components of the primary endpoint (all‐cause mortality, cardiovascular hospitalisations, change in NYHA class, change in global self assessment, change in peak VO2, change in E/e')

  2. Change in echocardiographic parameters of diastolic function (left atrial volume index, Grad of diastolic function, E/e', e', ratio between early (E) and late (atrial ‐ A) ventricular filling velocity (E/A), deceleration time, isovolumic relaxation time), systolic function (LVEF), left ventricular dimensions (left ventricular end diastolic diameter) and structure (left ventricular mass index) after 6 and 12 months

  3. Change in quality of life (SF‐36, Minnesota Living with Heart Failure Questionnaire, Hospital Anxiety and Depression Scale) after 6 and 12 months

  4. Change in ventilatory efficacy (VE/VCO2) and submaximal exercise capacity (anaerobic threshold, 6‐min walk distance) after 6 and 12 months

  5. Change in neurohumoral activation (N‐terminal pro brain natriuretic peptide) after 6 and 12 months

  6. Safety and tolerability of training intervention

  7. Gender aspects of all primary and secondary endpoints
Starting date 1 September 2011
Contact information Dr Frank Edelmann: fedelmann@med.uni‐goettingen.de
Notes Trial still recruiting. Recruitment completion expected in 2014 (author email reply 21 July 2013)