NCT Number: NCT02671903
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
West Hertfordshire Hospitals NHS Trust, Watford, Hertfordshire, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Baseline, 6 months and 12 months post randomisation.
Measured using peak oxygen uptake (VO2).
Time frame: Baseline, 6 months and 12 months post randomisation.
Measured during echocardiogram.
Time frame: Baseline, 6 months and 12 months post randomisation.
Measured from blood sample. Note: BNP was log-transformed before analysis in the mixed-model and then back transformed for presentation
Time frame: Baseline, 6 months and 12 months post randomisation.
Measured using Minnesota Score obtained from the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
Score range: 0 to 105, with higher scores indicating a worse outcome with more significant impairment in health-related quality of life
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.
NOTE: Cost effectiveness was unable to be completed for HOPE-HF and as such null results are displayed
Time frame: Baseline, 6 months and 12 months post randomisation.
Measured at completion of periods 1 & 2 (M6 & M12) - Percentage of time where device recorded ventricular pacing during each treatment period. Values are recorded across both arms.
Results are descriptive and displayed by treatment and by period.
Time frame: Baseline, 6 months and 12 months post randomisation.
Measured upon completion of run-in (as baseline) and periods 1 & 2 (M6 & M12). Device detected Atrial Fibrillation/Supraventricular Tachycardia (AF/SVT) burden recorded as a percentage of time over the 6-month treatment period.
Results are descriptive and displayed by treatment and by period.
Time frame: Baseline, 6 months and 12 months post randomisation.
Measured upon completion of run-in and periods 1 & 2 (BL, M6 & M12)
Results are descriptive and displayed by treatment and by period. Please also note that voltage is presented for both RA Lead and LV Lead.
Time frame: Baseline, 6 months and 12 months post randomisation.
Measured from electrocardiogram (ECG).
Time frame: Baseline, 6 months and 12 months post randomisation.
Measured upon completion of run-in and periods 1 & 2 (BL, M6 & M12).
Results are descriptive and displayed by treatment and by period. Please also note that lead impedance is presented for both RA Lead, HIS-Lead and LV Lead.
Time frame: Taken at Device Insertion Visit (2). Baseline measure.
Measured by time in minutes.
Time frame: Baseline, 6 months and 12 months post randomisation.
Taken from the Visual Analog Scale (VAS) Score from EQ5D Health State Question in EuroQol, 5-dimension, 5-level (EQ5D5L) questionnaire.
Score is on a 0-100 scale with 100 representing a better outcome for patients health state.
Imperial College London
Other
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.
Acronym: HOPE-HF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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