Reprogramming to Prevent Progressive Pacemaker-induced Remodelling (PPPR)

September 24, 2019 updated by: KK Witte, University of Leeds

Reprogramming to Prevent Progressive Pacemaker-Induced Remodelling

The aim is to provide evidence of the long-term benefits of personalised pacemaker programming on heart function and battery longevity.

This will be achieved by showing in a single centre, phase II, double-blind, randomised, placebo-controlled trial that reducing the amount of pacemaker beats to a minimum reverses these changes and extends battery life.

Study Overview

Detailed Description

Patients (n=70) with long-term (>2 years) permanent pacemakers with avoidable RV pacing will be invited to participate in a single-centre, phase II, randomised, double-blind placebo-controlled trial of optimised pacing programming versus standard care. Those randomised to the intervention arm will have personalised programming to avoid right ventricular pacing, whilst those allocated to standard care will have no programming changes made. All participants will be invited back at 6 months for a repeat echocardiogram, quality of life assessment (EQ-5D-5L), blood tests and pacemaker check.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Harrogate, United Kingdom
        • Harrogate District Foundation Trust
      • Leeds, United Kingdom, LS1 3EX
        • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic right ventricular bradycardia pacemaker implanted for at least 24 months
  • Willing and able to give informed consent for the intervention

Exclusion Criteria:

  • Known poor imaging quality patients (details of patients excluded for this reason will be recorded)
  • Patients with complete heart block and no reprogramming options

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Patients received echocardiogram but no pacemaker reprogramming or personalisation.
Active Comparator: Personalised programming
Patient will have tailored pacemaker programming based on echocardiographic findings, blood results, and symptoms in an attempt to minimise right ventricular pacing and extend battery longevity.
Reprogramming protocol already test in an observation cohort will be utilised which will direct physiologists to consider pacemaker mode, base rate, utilisation of rate response, hysteresis, sleep and rest rates as well as lead outputs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction
Time Frame: 6 months
Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LV remodelling parameters
Time Frame: 6 months
left ventricular end diastolic and systolic volumes
6 months
Quality of Life Measures
Time Frame: 6 months
EQ-5D, Minnesota living with Heart Failure Questionnaire
6 months
Battery Longevity
Time Frame: 6 months
Impedance
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

January 6, 2019

Study Completion (Actual)

August 6, 2019

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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