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Reprogramming to Prevent Progressive Pacemaker-induced Remodelling (PPPR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627585
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
KK Witte, University of Leeds

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.


Condition or disease Intervention/treatment Phase
Left Ventricular Dysfunction Heart Failure, Systolic Left Ventricular Failure Pacemaker; Complication, Mechanical Device: Personalised programming Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reprogramming to Prevent Progressive Pacemaker-Induced Remodelling
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : January 6, 2019
Actual Study Completion Date : August 6, 2019

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.
Device: Personalised programming
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 Measures :
  1. Left ventricular ejection fraction [ Time Frame: 6 months ]
    Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.


Secondary Outcome Measures :
  1. LV remodelling parameters [ Time Frame: 6 months ]
    left ventricular end diastolic and systolic volumes

  2. Quality of Life Measures [ Time Frame: 6 months ]
    EQ-5D, Minnesota living with Heart Failure Questionnaire

  3. Battery Longevity [ Time Frame: 6 months ]
    Impedance



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627585


Locations
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United Kingdom
Harrogate District Foundation Trust
Harrogate, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS1 3EX
Sponsors and Collaborators
University of Leeds
Investigators
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Principal Investigator: Klaus Witte, MD University of Leeds
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Responsible Party: KK Witte, Senior Lecturer in Cardiology, University of Leeds
ClinicalTrials.gov Identifier: NCT03627585    
Other Study ID Numbers: ICA-CDRF-2016-02-055
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by KK Witte, University of Leeds:
pacemaker
heart failure
left ventricular dysfunction
bradycardia
remodelling
Additional relevant MeSH terms:
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Heart Failure
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases