Rationale and design of the randomized multicentre His Optimized Pacing Evaluated for Heart Failure (HOPE-HF) trial

Keene, D. et al. (2018) Rationale and design of the randomized multicentre His Optimized Pacing Evaluated for Heart Failure (HOPE-HF) trial. ESC Heart Failure, 5(5), pp. 965-976. (doi: 10.1002/ehf2.12315) (PMID:29984912) (PMCID:PMC6165934)

Abstract

Aims: In patients with heart failure and a pathologically prolonged PR interval, left ventricular (LV) filling can be improved by shortening atrioventricular delay using His‐bundle pacing. His‐bundle pacing delivers physiological ventricular activation and has been shown to improve acute haemodynamic function in this group of patients. In the HOPE‐HF (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, double‐blind, randomized, crossover study aims to randomize 160 patients with PR prolongation (≥200 ms), LV impairment (EF ≤ 40%), and either narrow QRS (≤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 His‐bundle pacing and (ii) backup pacing only, using the non‐His 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, B‐type natriuretic peptide, daily patient activity levels, and safety and feasibility assessments of His‐bundle pacing. Conclusions: Hope‐HF 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 His‐bundle pacing improves exercise capacity and symptoms. We aim to complete recruitment by the end of 2018 and report in 2020.

• Item Type: Articles
• Additional Information: HOPE-HF is an investigator-initiated trial, funded by a British Heart Foundation (BHF) project grant (CS/15/3/31405). Medtronic are supporting the study, by supplying the His pacing leads, sheaths, CRT-P devices (in those patients who do not have a clinical indication for ICD implantation) and the additional cost of a CRT device over dual chamber ICD in those indicated for ICD implantation. Z.W. is supported by the BHF (FS/13/44/30291), D.K. and M.S.S. are BHF Clinical Research Training Fellows (FS/15/53/31615 and FS/14/27/30752), respectively. D.F. holds a BHF Fellowship FS/10/038.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Cleland, Professor John
• Authors: Keene, D., Arnold, A., Shun-Shin, M. J., Howard, J. P., Sohaib, S. A., Moore, P., Tanner, M., Quereshi, N., Muthumala, A., Chandresekeran, B., Foley, P., Leyva, F., Adhya, S., Falaschetti, E., Tsang, H., Vijayaraman, P., Cleland, J. G.F., Stegemann, B., Francis, D. P., and Whinnett, Z. I.
• Subjects: R Medicine > R Medicine (General)
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre
• Journal Name: ESC Heart Failure
• Publisher: Wiley
• ISSN: 2055-5822
• ISSN (Online): 2055-5822
• Published Online: 09 July 2018
• Copyright Holders: Copyright © 2018 The Authors
• First Published: First published in ESC Heart Failure 5(5): 965-976
• Publisher Policy: Reproduced under a Creative Commons License