The His Optimised Pacing Evaluated for Heart Failure Trial (HOPE-HF).

NCT02671903 | Completed Results DMC

• 1 other identifier: 15HH2828
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 15

Brief Summary

This is a multi-centre, prospective randomised double-blinded cross over study, recruiting a sub-population of patients with heart failure. All patients will be implanted with a CRT (Cardiac Resynchronisation Therapy) pacemaker with one of the leads positioned on the His bundle in order to obtain direct His-bundle capture. There will be a 2-month run-in period where the device is not active. A double-blinded cross-over design will then be employed to investigate the effect of His bundle pacing. Patients will 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. Endpoint measurements will be taken at baseline, 6 months and 12 months post randomisation. Treatment allocation will be blinded to the endpoint assessor and the patient. 126 patients will be needed to detect the expected effect size on the primary endpoint with 90% power. A total of 160 patients will be recruited to allow for patient drop-out.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Changes in Exercise Capacity.

  Measured using peak oxygen uptake (VO2).

  Baseline, 6 months and 12 months post randomisation.

Secondary Outcomes (11)

• Changes in Echocardiographic Measurement of Left Ventricular Function (Ejection Fraction)

  Baseline, 6 months and 12 months post randomisation.

• Changes in B-type Naturietic Peptide (BNP).

  Baseline, 6 months and 12 months post randomisation.

• Changes in Quality of Life Scores. - Minnesota

  Baseline, 6 months and 12 months post randomisation.

• Cost Effectiveness Analysis (Using a Custom Designed Resource Utilisation Questionnaire)

  Baseline.

• Changes in Percentage Pacing

  Baseline, 6 months and 12 months post randomisation.

Study Arms (2)

Pacemaker: AV optimised, His pacing

ACTIVE COMPARATOR

Subjects will remain in this arm for 6 months before being crossed-over. See below intervention details.

Device: Pacemaker: AV optimised, His pacing.

No pacing

NO INTERVENTION

Subjects will remain in this arm for 6 months before being crossed-over. The pacemaker will be programmed to VVI 30 bpm. Dynamic AV delay will be programmed off throughout the study.

Interventions

Pacemaker: AV optimised, His pacing. DEVICE

Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).

Pacemaker: AV optimised, His pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or above
• Ventricular Ejection Fraction (EF) \< 40%; BNP needs to be ≥250ng/L for patients with EF 36-40%
• New York Heart Association (NYHA) class II-IV
• PR interval ≥200ms
• Narrow QRS duration (≤140ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm

You may not qualify if:

• Permanent or persistent atrial fibrillation (AF)
• Paroxysmal atrial fibrillation with history of sustained AF (more than 24 hours) in the 6 months prior to screening
• Patients who are unable to perform cardiopulmonary exercise testing
• Other serious medical condition with life expectancy of less than 1 year
• Lack of capacity to consent
• Pregnancy
• Contraindication to use of the relevant study device or leads (as per current manuals from manufacturer)

Sponsors & Collaborators

• Imperial College London: lead
• British Heart Foundation: collaborator
• Medtronic: collaborator

Study Sites (15)

West Hertfordshire Hospitals NHS Trust

Watford, Hertfordshire, WD18 0HB, United Kingdom

Location

Basildon and Thurrock Hospitals NHS Foundation Trust

Basildon, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom

Location

Western Sussex Hospitals NHS Foundation Trust

Chichester, United Kingdom

Location

Medway NHS Foundation Trust

Gillingham, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Barts Health NHS Trust

London, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, United Kingdom

Location

Royal Brompton & Harefield NHS Foundation Trust

London, United Kingdom

Location

Papworth Hospital NHS Foundation Trust

Papworth Everard, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Location

Great Western Hospitals NHS Foundation Trust

Swindon, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr Zachary I Whinnett
• Organization: Imperial College London

z.whinnett@imperial.ac.uk

+44 (0)20 7594 5735

Study Officials

• Zachary Whinnett, BMBS MRCP

  Senior Lecturer, Consultant Cardiologist and Electrophysiologist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 2, 2016
• Study Start: January 1, 2016
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months post publication of data
• Access Criteria: The anonymised data set will be shared with the journal in which the papers are published. We will make the data available for analysis by non-commercial researchers on request to the Chief investigator.

Locations

GB (15)