- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03627585
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICA-CDRF-2016-02-055
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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