The His optimised pacing evaluated for heart failure trial
| ISRCTN | ISRCTN86179285 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86179285 |
| ClinicalTrials.gov number | NCT02671903 |
| Secondary identifying numbers | 20226 |
- 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
Plain English Summary
Not provided at time of registration
Contact information
Scientific
Cardiovascular Medicine Unit
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
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
| Study design | Multi-centre prospective randomised double-blinded cross over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| 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 | 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 study start date | 22/12/2015 |
| Overall study end date | 31/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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. |
| Total final enrolment | 198 |
| 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 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 | 31/01/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Du Cane Road
London
W12 0HS
United Kingdom
Sponsor information
University/education
Clinical Medical Research
3rd Floor
Reynolds Building
St Dunstan's Road
London
W6 8RP
England
United Kingdom
"ROR" |
https://ror.org/041kmwe10 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| 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? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Basic results | 17/11/2023 | No | No | ||
| Results article | 01/02/2023 | 17/11/2023 | Yes | No | |
| 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
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.
