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

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ClinicalTrials.gov Identifier: NCT02671903
Recruitment Status : Active, not recruiting
First Posted : February 2, 2016
Last Update Posted : June 22, 2020
Sponsor:
Collaborators:
British Heart Foundation
Medtronic
Information provided by (Responsible Party):
Imperial College London

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.


Condition or disease Intervention/treatment Phase
Heart Failure Device: Pacemaker: AV optimised, His pacing. Not Applicable

Detailed Description:

Patients entering the study will attend for implantation of a CRT pacemaker device with one lead positioned on the His bundle. This will be performed either at the patient's local hospital or at Imperial College NHS healthcare Trust, no later than 4 months after the patient's screening visit.

All patients will be implanted with a Pacemaker or Implantable cardioverter defibrillator (ICD). In all patients a pacing lead will be positioned in the right atrium (typically the right atrial appendage). All patients will have a pacemaker lead 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.

In patients who do not have an indication for an Implantable cardioverter defibrillator (ICD) a second ventricular lead will be implanted in a lateral branch of the coronary sinus. If direct His pacing has not been successfully achieved then a further lead will be positioned at the RV apex. In patients who do have an indication for an Implantable cardioverter defibrillator the ICD lead will be positioned in the right ventricle (either RV apex or RV septum).

AV delay optimisation will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands). The BHF (British Heart Foundation) alternation protocol will be used in order to minimise the effect of background noise.

After implantation of the device there will be a 2 month run-in period prior to randomisation, the device will be programmed not to deliver His bundle pacing therapy during this period.(Back up only pacing and defibrillator function will be enabled).

Two months after patients are implanted with their device, patients will be randomised to either receive active pacing treatment or back up only pacing (pacemaker programmed to VVI 30 bpm). After a further 6 months they will be crossed over to the alternative treatment arm. Treatment allocation will be obtained using an Interactive Web Response System (IWRS) programmed with a randomisation schedule provided by the trial statistician. Appropriate blocking will be used.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AV Optimisation Delivered With Direct His Bundle Pacing, in Patients With Heart Failure, Long PR Without Left Bundle Branch Block: Randomised Multi-centre Clinical Outcome Study.
Actual Study Start Date : January 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Pacemaker: AV optimised, His pacing
Subjects will remain in this arm for 6 months before being crossed-over. See below intervention details.
Device: Pacemaker: AV optimised, His pacing.
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).

No Intervention: No pacing
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.



Primary Outcome Measures :
  1. Changes in exercise capacity. [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]
    Measured using peak oxygen uptake (VO2).


Secondary Outcome Measures :
  1. Changes in Echocardiographic measurement of left ventricular function (Ejection Fraction) [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]
    Measured during echocardiogram.

  2. Changes in B-type Naturietic Peptide (BNP). [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]
    Measured from blood sample.

  3. Changes in Quality of Life Scores. [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]
    Measured using Quality of Life Questionnaire.

  4. Cost effectiveness analysis (using a custom designed Resource Utilisation Questionnaire) [ Time Frame: Baseline. ]
    The analysis will be based on an intention-to-treat (ITT) principle. The economic evaluation will compare incremental costs and incremental outcomes of the direct His-bundle pacing against the standard medical care. The study will be performed from a societal perspective, which takes all relevant cost-categories and effects into account. The economic evaluation will consist of two parts, a cost-effectiveness analysis (CEA) and a cost utility analysis (CUA). In the CEA the incremental cost-effectiveness ratio (ICER) will be expressed as the incremental costs per point improvement in exercise capacity in peak VO2. The primary outcome measure in the CUA will be Qualitative Adjusted Life Years (QALYs), based on the EQ5D and Minnesota questionnaire scores.

  5. Changes in percentage pacing. [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]
    Measured during pacing check.

  6. Changes in arrythmia burden (%). [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]
    Measured during pacing check.

  7. Changes in pacing thresholds (Volts). [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]
    Measured during pacing check.

  8. Changes in R wave amplitude. [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]
    Measured from electrocardiogram (ECG).

  9. Changes in lead impedance (Ohms). [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]
    Measured during pacing check.

  10. Fluoroscopy time during device insertion. [ Time Frame: Baseline. ]
    Measured by time in minutes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671903


Locations
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United Kingdom
West Hertfordshire Hospitals NHS Trust
Watford, Hertfordshire, United Kingdom, WD18 0HB
Basildon and Thurrock Hospitals NHS Foundation Trust
Basildon, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom
Western Sussex Hospitals NHS Foundation Trust
Chichester, United Kingdom
Medway NHS Foundation Trust
Gillingham, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Hammersmith Hospital
London, United Kingdom, W12 0HS
Barts Health NHS Trust
London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
London, United Kingdom
Papworth Hospital NHS Foundation Trust
Papworth Everard, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Great Western Hospitals NHS Foundation Trust
Swindon, United Kingdom
Sponsors and Collaborators
Imperial College London
British Heart Foundation
Medtronic
Investigators
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Principal Investigator: Zachary Whinnett, BMBS MRCP Senior Lecturer, Consultant Cardiologist and Electrophysiologist
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02671903    
Other Study ID Numbers: 15HH2828
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication. The data set will be created as an anonymised data sharing package and will be available post publication of data.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases