HOPE - HF
Research type
Research Study
Full 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 The His Optimised Pacing Evaluated for Heart Failure Trial (HOPE-HF)
IRAS ID
183327
Contact name
Zachary Whinnett
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Summary of Research
Heart failure is a serious clinical problem, which often causes severe symptoms. The risk of death in the first year after diagnosis is similar to that seen with several types of cancer. Cardiac Resynchronisation therapy (CRT) is a type of pacemaker therapy, which improves symptoms, reduces hospital admissions and decreases the risk of death. However, it is only effective in patients who have heart failure and a disturbance in the electrical activation of the main pumping chamber of the heart (left bundle branch block).
Some patients with heart failure have normal activation of the ventricles, but the onset of activation is delayed. This is called ‘PR interval prolongation.’ These patients also have a higher risk of developing heart failure symptoms and death but do not benefit from CRT therapy currently. In this study we will assess whether a special type of pacing therapy, called direct His bundle pacing, can improve patients ability to exercise and reduce symptoms due to their heart failure.The goal of this research is to find out whether His bundle pacing, together with a method for identifying the best pacemaker settings, improves patients ability to exercise. We will test this new
treatment in a group of patients who are not currently targeted for pacing therapy to treat their heart failure.If the treatment is found to be effective, this would be an exciting advance, as it would mean we have a new treatment for a group of patients with heart failure. These patients are often very limited by their symptoms and therefore a new treatment which reduces symptoms would be very important.
Summary of Results
The aim of the HOPE-HF study was to find out whether His bundle pacing, together with a method for identifying the best pacemaker settings, improves people’s ability to exercise (measured by max VO2, commonly written as MVO2). This treatment was tested in a people who are not currently eligible for pacemaker therapy to treat their heart failure. All patients that took part in the study were included in the analysis. The average MVO2 measurement during pacing was 13.98 mL/(kg·min). The average MVO2 reading without pacing was 13.71 mL/(kg·min). Therefore, exercise capacity was higher during pacing treatment +0.25 mL/(kg·min). This small improvement was, however, not statistically significant (p=0.3) Therefore, we cannot conclude based on these results, that the pacing treatment results in improved exercise capacity, since we can’t be certain that this finding didn’t occur due to chance. However, we did find that quality-of-life was significantly improved with the His bundle pacing treatment. The Minnesota questionnaire scores (used to assess severity of heart failure symptoms) improved, by a statistically significant (p=0.03) average of 3.7 points. A further important finding of the study was that His bundle pacing is safe and did not worsen heart function. Overall, the HOPE-HF study provides evidence that His-Pacing treatment can improve a quality-of-life, when delivered to certain people with heart failure.REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/1402
Date of REC Opinion
15 Oct 2015
REC opinion
Further Information Favourable Opinion