Optimising pacing for contractility 2
Research type
Research Study
Full title
Mechanisms, safety and efficacy of optimising pacemaker heart rate for contractility: effects on walk time, cardiac remodelling and quality of life.
IRAS ID
277578
Contact name
Klaus Witte
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 29 days
Research summary
We can reliably identify an optimum heart rate range for the power of contraction of the main pumping chamber of the heart in patients with chronic heart failure (CHF). In a preliminary study, we have shown that keeping the heart rate in this range rather than forcing it to go faster than this with a pacemaker leads to increased exercise time on a treadmill and also limits deterioration in heart function. \nWe now wish to confirm these findings in a larger study, and also answer further key questions:\n1) do similar results occur in people with less severe heart muscle weakness?\n2) what are the mechanisms of action?\n3) what is the benefit of any pacemaker-supported heart rate rise versus no pacemaker-supported heart rate rise?\n4) can the optimal heart rate rise be predicted from baseline (non-pacemaker derived) variables?\nWe will invite 400 patients with CHF to participate, (accounting for drop-out aiming for 360 paired datasets) to undergo our non-invasive unltrasound heart scan assessment to establish their individual optimal heart rate for power. They will then perform a treadmill walk test, have some blood tests and fill out quality of life questionnaires. We will also ask them if they want to participate in four smaller substudies to try and find out how the optimal heart rate might improve exercise capacity compared with the two standard approaches and whether this has longer-term effects (over 12m).\nParticipants will be randomised to one of three arms: 1) optimal rate-response settings based upon their own target optimal heart rate, 2) standard rate response settings which are simply age-related, or 3) no pacemaker-supported heart rate rise. \nParticipants will then be followed up at 6 months in face-to-face visits at which point the tests will be repeated and will also complete optional postal quality of life questionnaires at 9 and 12 months.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
20/YH/0087
Date of REC Opinion
20 Mar 2020
REC opinion
Favourable Opinion