Reprogramming to Prevent Progressive Pacemaker-induced Remodelling (PPPR)
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| ClinicalTrials.gov Identifier: NCT03627585 |
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Recruitment Status :
Completed
First Posted : August 13, 2018
Last Update Posted : September 26, 2019
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Sponsor:
University of Leeds
Information provided by (Responsible Party):
KK Witte, University of Leeds
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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 |
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 (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 |
|---|---|
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No Intervention: Usual Care
Patients received echocardiogram but no pacemaker reprogramming or personalisation.
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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.
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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 :
- 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 :
- LV remodelling parameters [ Time Frame: 6 months ]left ventricular end diastolic and systolic volumes
- Quality of Life Measures [ Time Frame: 6 months ]EQ-5D, Minnesota living with Heart Failure Questionnaire
- Battery Longevity [ Time Frame: 6 months ]Impedance
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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
| 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
| Principal Investigator: | Klaus Witte, MD | University of Leeds |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| 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:
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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 |