NCT03422705

A Pilot Study: Preventing Adverse Remodelling Following Pacemaker Implantation

Status unknown Phase 2 Last updated 2 November 2022

What this trial tests

Phase 2 trial testing Optimised programming in Pacemakers, Heart Failure in 75 participants. Status unknown.

Timeline

1 December 2022

Primary endpoint
1 December 2022

1 December 2022

Quick facts

Lead sponsor	University of Leeds
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	prevention
Enrollment	75
Start date	1 December 2022
Primary completion	1 December 2022
Estimated completion	1 December 2022

Drugs / interventions tested

• Optimised programming
• Lisinopril (lisinopril) — full drug profile →
• Standard care — full drug profile →

Conditions studied

• Pacemakers, Heart Failure — all drugs for Pacemakers, Heart Failure →

Sponsor

University of Leeds

Who can join

18 and older, any sex, with Pacemakers, Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Post-myocardial infarction fibrosis: Pathophysiology, examination, and intervention.
   Yin X, Yin X, Pan X, Zhang J, et al · · 2023 · cited 50× · PMID 37056987 · DOI 10.3389/fphar.2023.1070973