A Pilot Study: Preventing Adverse Remodelling Following Pacemaker Implantation
Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Almost 40,000 people in the United Kingdom receive a new pacemaker annually. Because the
pacemaker does not use the heart's normal conduction system, electrical activity from the
pacemaker spreads more slowly, disturbing the timing of the heart's contraction, which can
lead to heart muscle weakness and heart failure (HF).
Those with the greatest requirement for a pacemaker and highest percentage of pacemaker beats
are those at highest risk of heart muscle weakness.
This pilot study will be in two stages. Patients will be approached after their pacemaker
implant. Allocation to all treatment arms will be at random.
At the normal 6w visit, all participants will undergo cardiac ultrasound, blood tests and
complete a quality of life questionnaire. Participants will be allocated to optimal pacemaker
programming (to limit pacemaker heartbeats) or standard care. Those allocated optimal
programming will return 3m after the implant and those still needing a high proportion of
pacemaker beats, will be asked to have a cardiac magnetic resonance (CMR) scan and will be
randomly allocated to an angiotensin converting enzyme inhibitor (ACE inhibitor) a common
treatment for blood pressure and HF or not. After another 6m all will undergo heart
ultrasound, blood test and quality of life assessment, and where relevant, a second CMR scan.