3 research outputs found
Rationale and design of the randomized multicentre His Optimized Pacing Evaluated for Heart Failure (HOPE-HF) trial:HOPE HF Trial rationale and design
Aims In patients with heart failure and a pathologically prolonged PR interval, left ventricular (LV) filling can be improved by shortening atrioventricular delay using Hisâbundle pacing. Hisâbundle pacing delivers physiological ventricular activation and has been shown to improve acute haemodynamic function in this group of patients. In the HOPEâHF (His Optimized Pacing Evaluated for Heart Failure) trial, we are investigating whether these acute haemodynamic improvements translate into improvements in exercise capacity and heart failure symptoms. Methods and results This multicentre, doubleâblind, randomized, crossover study aims to randomize 160 patients with PR prolongation (â„200 ms), LV impairment (EF †40%), and either narrow QRS (â€140 ms) or right bundle branch block. All patients receive a cardiac device with leads positioned in the right atrium and the His bundle. Eligible patients also receive a defibrillator lead. Those not eligible for implantable cardioverter defibrillator have a backup pacing lead positioned in an LV branch of the coronary sinus. Patients are allocated in random order to 6 months of (i) haemodynamically optimized dual chamber Hisâbundle pacing and (ii) backup pacing only, using the nonâHis ventricular lead. The primary endpoint is change in exercise capacity assessed by peak oxygen uptake. Secondary endpoints include change in ejection fraction, quality of life scores, Bâtype natriuretic peptide, daily patient activity levels, and safety and feasibility assessments of Hisâbundle pacing. Conclusions HopeâHF aims to determine whether correcting PR prolongation in patients with heart failure and narrow QRS or right bundle branch block using haemodynamically optimized dual chamber Hisâbundle pacing improves exercise capacity and symptoms. We aim to complete recruitment by the end of 2018 and report in 2020