A Pilot Study: Preventing Adverse Remodelling Following Pacemaker Implantation

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leeds
• Treatments: Lisinopril

Criteria

Inclusion criteria:

• New RV pacemaker implant (<6 weeks)

• Willing and able to give informed consent

• Stable medical therapy (≥6w)

Exclusion criteria:

• Poor imaging quality

• Patients without heart block

• Guideline-mandated ACEi or ARB