A Pilot Study: Preventing Adverse Remodelling Following Pacemaker Implantation

NCT03422705 | Unknown Phase 2

• 1 other identifier: 242990
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular ejection fraction

  Difference in change between the groups

  6 months

Secondary Outcomes (2)

• Change in left ventricular end systolic diameter

  6 months

• Change in left ventricular end diastolic diameter

  6 months

Study Arms (3)

Standard of care

SHAM COMPARATOR

No intervention - no programming, no medical intervention.

Other: Standard care

Optimised programming

EXPERIMENTAL

Optimised pacemaker programming to avoid right ventricular pacing.

Device: Optimised programming; Other: Standard care

Medical therapy

EXPERIMENTAL

Lisinopril uptitrated to optimally tolerated dose.

Device: Optimised programming; Drug: Lisinopril; Other: Standard care

Interventions

Optimised programming DEVICE

Optimised programming to avoid RV pacing when possible.

Medical therapy; Optimised programming

Lisinopril DRUG

Uptitration of lisinopril

Medical therapy

Standard care OTHER

No pacemaker adjustment or medical therapy

Medical therapy; Optimised programming; Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New RV pacemaker implant (\<6 weeks)
• Willing and able to give informed consent
• Stable medical therapy (≥6w)

You may not qualify if:

• Poor imaging quality
• Patients without heart block
• Guideline-mandated ACEi or ARB

Sponsors & Collaborators

• University of Leeds: lead

MeSH Terms

Conditions

Heart Failure

Interventions

Lisinopril; Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Klaus Witte, MD

CONTACT

+441133926642; k.k.witte@leeds.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Cardiology

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 6, 2018
• Study Start: December 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share