Preventing progressive pacemaker-induced remodelling
Research type
Research Study
Full title
Reprogramming to Prevent Progressive Pacemaker-induced Remodelling
IRAS ID
211016
Contact name
Klaus Witte
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
3 years, 3 months, 1 days
Research summary
Aims: I aim to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity.
Background: Permanent pacemakers are a common treatment for slow heartbeats. In
the UK 350,000 people have a pacemaker, and each year another 40,000 receive
them. Having a pacemaker is a safe procedure but over the long-term pacemaker
patients are at higher risk than the normal population of developing heart muscle
weakness which can cause heart failure and puts them at greater risk of hospitalization and death related to the amount of pacing required.We have previously shown in a simple observational study in 66 people that lowering the percentage of paced heartbeats by careful tailored programming leads to improvements in heart function without any adverse effects on symptoms or quality of life. We have also demonstrated that 1 in 5 people having a pacemaker battery replacement die within one year of the operation - mostly because these are often very old people.
Methods: This will be a two- centre, phase II, double-blind, randomised, controlled trial to demonstrate that reducing the amount of pacemaker beats to a minimum reverses these changes to heart function and extends battery life.
Patients attending our other studies (YH-12-097 and 15/EM/0566 not dependent upon their pacemaker; anticipated n=70) will be randomised either to personalised programming to reduce the amount of pacing or to control (no programming changes). Neither I (as the investigator) nor the patient will know their allocation as a colleague will undertake the reprogramming. Patients in the trial will be invited back at 6 months after randomisation to examine the effect. Endpoint tests done at baseline and 6 months will include heart function (on echocardiogram), quality of life, and battery longevity.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0337
Date of REC Opinion
30 Aug 2016
REC opinion
Further Information Favourable Opinion