N/A
Completed N=183
The His Optimised Pacing Evaluated for Heart Failure Trial (HOPE-HF).
Source: ClinicalTrials.gov NCT02671903 ↗Enrolled (actual)
183
Serious AEs
14.5%
Results posted
Feb 2025
Primary outcomePrimary: Changes in Exercise Capacity. — 14.0; 13.7 ml/min/kg — p=0.3
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Exercise Capacity. |
14.0; 13.7 | 0.3 |
| SECONDARY Changes in Echocardiographic Measurement of Left Ventricular Function (Ejection Fraction) |
33.4; 33.0 | — |
| SECONDARY Changes in B-type Naturietic Peptide (BNP). |
323; 335 | — |
| SECONDARY Changes in Quality of Life Scores. - Minnesota |
30.9; 34.6 | — |
| SECONDARY Cost Effectiveness Analysis (Using a Custom Designed Resource Utilisation Questionnaire) |
— | — |
| SECONDARY Changes in Percentage Pacing |
90.8; 0; 1.4; 93.5 | — |
| SECONDARY Changes in Arrythmia Burden (%). |
0.1; 0.3; 0.2; 0.1; 0.4; 1.5 | — |
| SECONDARY Changes in Pacing Thresholds (Volts). |
0.82; 0.78; 0.82; 0.74; 0.78; 0.79 | — |
| SECONDARY Changes in R Wave Amplitude. |
— | — |
| SECONDARY Changes in Lead Impedance (Ohms). |
460.8; 480.8; 475.2; 469.1; 452.0; 473.7 | — |
| SECONDARY Fluoroscopy Time During Device Insertion. |
16.5; 16.0 | — |
| SECONDARY Changes in Quality of Life Scores. - EQ5D Health State Score |
66.3; 64.3 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT02671903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.