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A Pilot Study: Preventing Adverse Remodelling Following Pacemaker Implantation

NCT03422705 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-11-02

No results posted yet for this study

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.

Conditions

  • Pacemakers, Heart Failure

Interventions

DEVICE

Optimised programming

Optimised programming to avoid RV pacing when possible.

DRUG

Lisinopril

Uptitration of lisinopril

OTHER

Standard care

No pacemaker adjustment or medical therapy

Sponsors & Collaborators

  • University of Leeds

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2022-12-01
Completion
2022-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03422705 on ClinicalTrials.gov