The His optimised pacing evaluated for heart failure trial

ISRCTN	ISRCTN86179285
DOI	https://doi.org/10.1186/ISRCTN86179285
ClinicalTrials.gov (NCT)	NCT02671903
Protocol serial number	20226
Sponsor	Imperial College London
Funder	British Heart Foundation

Submission date: 20/01/2016
Registration date: 20/01/2016
Last edited: 17/11/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daniel Keene
Scientific

Cardiovascular Medicine Unit
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Ms Myril Mariveles
Public

HOPE HF Research Office
Room C2036
Peart-Rose Clinic
Ground Floor
C Block North
NHLI Imperial College London
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom

Study information

Primary study design	Interventional
Study design	Multi-centre prospective randomised double-blinded cross over study
Secondary study design	Randomised cross over trial
Study type	Participant information sheet
Scientific title	AV optimisation delivered with direct His bundle pacing, in patients with heart failure, long PR without left bundle branch block: A randomised multi-centre clinical outcome study
Study acronym	HOPE - HF
Study objectives	The aim of this study is to investigate the effects of direct His bundle pacing in patients with heart failure.
Ethics approval(s)	First Medical Research Ethics Committee, 15/10/2015, ref: 15/LO/1402
Health condition(s) or problem(s) studied	Heart failure
Intervention	All patients will be implanted with a pacemaker or implantable cardioverter defibrillator with one of the leads positioned on the His bundle in order to obtain direct His-bundle capture. If it is not possible to successfully implant a His-bundle lead with selective direct His bundle capture or non-selective capture with <40 ms prolongation of the QRS duration, then a lead will be implanted in a lateral branch of the coronary sinus as an alternative approach. Patients will then be allocated in random order to 6-month treatment periods in each of the following two states 1. No pacing 2. AV-optimised direct His-bundle pacing
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Pacemaker or implantable cardioverter defibrillator (ICD) with one of the leads positioned on the His bundle
Primary outcome measure(s)	Exercise capacity is determined by measuring peak oxygen uptake (VO2) at baseline, 6 and 12 months.
Key secondary outcome measure(s)	1. Changes in B-type Naturietic Peptide (BNP) are measured at baseline, 6 and 12 months 2. Changes in Quality of Life Scores are measured at baseline, 6 and 12 months 3. Cost effectiveness analysis is completed at baseline, 6 and 12 months 4. Echocardiographic measurement of left ventricular function and remodeling is measured at baseline, 6 and 12 months 5. Fluoroscopy time during device insertion is measured 2 months pre-randomisation and during device insertion 6. Percentage pacing, arrhythmia burden, pacing threshols, R wave amplitude and lead impedance are measured at baseline, 6 and 12 months
Completion date	31/10/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	160
Total final enrolment	198
Key inclusion criteria	1. Aged 18 or above 2. Ventricular Ejection Fraction (EF) < 35% 3. New York Heart Association (NYHA) class II-IV 4. PR interval =200ms 5. Narrow QRS duration (=140ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm
Key exclusion criteria	1. Permanent or persistent atrial fibrillation 2. Paroxysmal atrial fibrillation with history of sustained AF (more than 24 hours) in the 6 months prior to screening 3. Patients who are unable to perform cardiopulmonary exercise testing 4. Other serious medical condition with life expectancy of less than 1 year or if it is anticipated patients will require MRI scanning 5. Lack of capacity to consent 6. Pregnancy (female participants of reproductive age will be eligible for inclusion in the study, subject to a negative pregnancy test prior to randomisation)
Date of first enrolment	22/12/2015
Date of final enrolment	31/01/2019

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Hammersmith Hospital

Cardiovascular Medicine Unit
Du Cane Road
London
W12 0HS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/02/2023	17/11/2023	Yes	No
Basic results			17/11/2023	No	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Statistical Analysis Plan	version 1.2 (pages 1-20)	15/09/2020	17/11/2023	No	No
Statistical Analysis Plan	version 1.2 (pages 21-40)	15/09/2020	17/11/2023	No	No

Additional files

ISRCTN86179285_BasicResults.pdf: Basic results
ISRCTN86179285_SAP_v1.2_pages 1 to 20_15Sep2020.pdf: Statistical Analysis Plan
ISRCTN86179285_SAP_v1.2_pages 21 to 40_15Sep2020.pdf: Statistical Analysis Plan

Editorial Notes

17/11/2023: The following changes have been made:
1. Publication reference added.
2. A basic results summary has been uploaded.
3. A statistical analysis plan (SAP) in two sections has been uploaded.
30/12/2021: Internal review.
05/08/2020: The following changes were made to the trial record:
1. The public contact was changed.
2. The overall end date was changed from 01/07/2020 to 31/10/2020.
3. The intention to publish date was changed from 01/07/2021 to 31/10/2021.
4. The total final enrolment was changed from 206 to 198.
22/11/2019: The IPD sharing statement was added to the publication and dissemination plan.
13/11/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 06/10/2019 to 31/01/2019.
2. The overall trial end date was changed from 06/10/2019 to 01/07/2020.
3. The intention to publish date was changed from 06/10/2020 to 01/07/2021.
4. The total final enrolment number was added.
12/07/2019: ClinicalTrials.gov number added.
02/04/2019: The condition has been changed from "Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Heart Failure" to "Heart failure" following a request from the NIHR.
01/11/2017: Internal review.