Condition category
Circulatory System
Date applied
20/01/2016
Date assigned
20/01/2016
Last edited
29/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Plain English summary under review.

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Keene

ORCID ID

Contact details

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

Type

Public

Additional contact

Miss Aisha Anjum

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20226

Study information

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

Acronym

HOPE -­ HF

Study hypothesis

The aim of this study is to investigate the effects of direct His bundle pacing in patients with heart failure.

Ethics approval

First Medical Research Ethics Committee, 15/10/2015, ref: 15/LO/1402

Study design

Multi-centre prospective randomised double-blinded cross over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: 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 < 40ms 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 six month treatment periods in each of the following two states
1. No pacing
2. AV optimised direct His-bundle pacing

Intervention type

Other

Phase

Drug names

Primary outcome measures

Exercise capacity is determined by measuring peak oxygen uptake (VO2) at baseline, 6 and 12 months.

Secondary outcome measures

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

Overall trial start date

22/12/2015

Overall trial end date

06/10/2019

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 160; UK Sample Size: 160; Description: A total of 160 patients will be recruited to allow for patient drop-out. 126 patients will be needed to detect the expected effect size on the primary endpoint with 90% power.

Participant 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)

Recruitment start date

22/12/2015

Recruitment end date

06/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Imperial College London

Sponsor details

Clinical Medical Research
3rd Floor
Reynolds Building
St Dunstan's Road
London
W6 8RP
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes