Left Ventricular DysfunctionPPPRNCT03627585
Reprogramming to Prevent Progressive Pacemaker-induced Remodelling
A study testing Personalised programming in people with Left Ventricular Dysfunction and Heart Failure, Systolic, run by University of Leeds at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Dysfunction, Heart Failure, Systolic, Left Ventricular Failure
- What is being tested?
- Personalised programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Aug 2017to 6 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic right ventricular bradycardia pacemaker implanted for at least 24 months
- Willing and able to give informed consent for the intervention
Who cannot join
- Known poor imaging quality patients (details of patients excluded for this reason will be recorded)
- Patients with complete heart block and no reprogramming options
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Harrogate District Foundation Trust
Harrogate
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX
About this study
Official title: 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.
Read the 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.
- Conditions
- Left Ventricular Dysfunction, Heart Failure, Systolic, Left Ventricular Failure, Pacemaker; Complication, Mechanical
- Being tested
- Personalised programming
- Keywords
- pacemaker, heart failure, left ventricular dysfunction, bradycardia, remodelling
- Medical subject headings
- Ventricular Dysfunction, Left, Heart Failure, Systolic, Heart Failure, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised programmingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients received echocardiogram but no pacemaker reprogramming or personalisation. |
| Personalised programming | Active comparator | 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. Receives: Device: Personalised programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.
Measured: 6 months
Secondary outcomes (3)
LV remodelling parameters
left ventricular end diastolic and systolic volumes
Measured: 6 months
Quality of Life Measures
EQ-5D, Minnesota living with Heart Failure Questionnaire
Measured: 6 months
Battery Longevity
Impedance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Aug 2017
- Primary completion6 Jan 2019
- Study completion6 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KK Witte, University of Leeds
- Investigators
- Klaus Witte, MD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627585
- Sponsor's protocol ID
- ICA-CDRF-2016-02-055
- Acronym
- PPPR
- Status last verified
- Sep 2019
- First submitted
- 6 Aug 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34898655
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reprogramming to Prevent Progressive Pacemaker-Induced Remodelling
- ClinicalTrials.gov ID
- NCT03627585
- Acronym / sponsor ID
- PPPR / ICA-CDRF-2016-02-055
- Conditions
- Left Ventricular Dysfunction, Heart Failure, Systolic, Left Ventricular Failure, Pacemaker; Complication, Mechanical
- Keywords
- pacemaker, heart failure, left ventricular dysfunction, bradycardia, remodelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 6 Jan 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients received echocardiogram but no pacemaker reprogramming or personalisation. |
| Personalised programming | Active comparator | Device: Personalised programmingPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic right ventricular bradycardia pacemaker implanted for at least 24 months
- Willing and able to give informed consent for the intervention
Key exclusion criteria (2 listed)
- Known poor imaging quality patients (details of patients excluded for this reason will be recorded)
- Patients with complete heart block and no reprogramming options
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalised programmingReprogramming 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. | Device | Personalised programming |
Primary outcome
Left ventricular ejection fraction
Time frame: 6 months
Left ventricular functional measure using either 3D volumes or Simpson's Biplane obtained from echocardiographic images.
3 secondary outcomes
LV remodelling parameters
Time frame: 6 months
Quality of Life Measures
Time frame: 6 months
Battery Longevity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Derived from this study: PubMed 34898655Paton 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Witte, MD principal investigator
University of Leeds
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalised programming in people with Left Ventricular Dysfunction and Heart Failure, Systolic, run by University of Leeds at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03627585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.