The His Optimised Pacing Evaluated for Heart Failure Trial (HOPE-HF). (HOPE-HF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02671903|
Recruitment Status : Active, not recruiting
First Posted : February 2, 2016
Last Update Posted : June 22, 2020
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- Changes in exercise capacity. [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]Measured using peak oxygen uptake (VO2).
- Changes in Echocardiographic measurement of left ventricular function (Ejection Fraction) [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]Measured during echocardiogram.
- Changes in B-type Naturietic Peptide (BNP). [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]Measured from blood sample.
- Changes in Quality of Life Scores. [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]Measured using Quality of Life Questionnaire.
- 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.
- Changes in percentage pacing. [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]Measured during pacing check.
- Changes in arrythmia burden (%). [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]Measured during pacing check.
- Changes in pacing thresholds (Volts). [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]Measured during pacing check.
- Changes in R wave amplitude. [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]Measured from electrocardiogram (ECG).
- Changes in lead impedance (Ohms). [ Time Frame: Baseline, 6 months and 12 months post randomisation. ]Measured during pacing check.
- Fluoroscopy time during device insertion. [ Time Frame: Baseline. ]Measured by time in minutes.
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
|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|
|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|
|Principal Investigator:||Zachary Whinnett, BMBS MRCP||Senior Lecturer, Consultant Cardiologist and Electrophysiologist|