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Reprogramming to Prevent Progressive Pacemaker-induced Remodelling (PPPR)

Primary Purpose

Left Ventricular Dysfunction, Heart Failure, Systolic, Left Ventricular Failure

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Personalised programming
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Left Ventricular Dysfunction focused on measuring pacemaker, heart failure, left ventricular dysfunction, bradycardia, remodelling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harrogate District Foundation Trust
  • Leeds Teaching Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care

Personalised programming

Arm Description

Patients received echocardiogram but no pacemaker reprogramming or personalisation.

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.

Outcomes

Primary Outcome Measures

Left ventricular ejection fraction
Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.

Secondary Outcome Measures

LV remodelling parameters
left ventricular end diastolic and systolic volumes
Quality of Life Measures
EQ-5D, Minnesota living with Heart Failure Questionnaire
Battery Longevity
Impedance

Full Information

First Posted
August 6, 2018
Last Updated
September 24, 2019
Sponsor
University of Leeds
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1. Study Identification

Unique Protocol Identification Number
NCT03627585
Brief Title
Reprogramming to Prevent Progressive Pacemaker-induced Remodelling
Acronym
PPPR
Official Title
Reprogramming to Prevent Progressive Pacemaker-Induced Remodelling
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
January 6, 2019 (Actual)
Study Completion Date
August 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Dysfunction, Heart Failure, Systolic, Left Ventricular Failure, Pacemaker; Complication, Mechanical
Keywords
pacemaker, heart failure, left ventricular dysfunction, bradycardia, remodelling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients received echocardiogram but no pacemaker reprogramming or personalisation.
Arm Title
Personalised programming
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Personalised programming
Intervention Description
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.
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction
Description
Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
LV remodelling parameters
Description
left ventricular end diastolic and systolic volumes
Time Frame
6 months
Title
Quality of Life Measures
Description
EQ-5D, Minnesota living with Heart Failure Questionnaire
Time Frame
6 months
Title
Battery Longevity
Description
Impedance
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Witte, MD
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harrogate District Foundation Trust
City
Harrogate
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34898655
Citation
Paton MF, Gierula J, Lowry JE, Cairns DA, Bose Rosling K, Cole CA, McGinlay M, Straw S, Byrom R, Cubbon RM, Kearney MT, Witte KK. Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial. PLoS One. 2021 Dec 13;16(12):e0259450. doi: 10.1371/journal.pone.0259450. eCollection 2021.
Results Reference
derived

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Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

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