Pacing-Induced CardiomyopathyPROTECT-UPNCT06052475
Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
A study testing Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing) and Continued RV Pacing (Right Ventricular Pacing) in people with Pacing-Induced Cardiomyopathy and Heart Failure, run by Imperial College London at 12 sites in United Kingdom.
Trial summary
Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing symptoms from pacing induced or worsened cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacing-Induced Cardiomyopathy, Heart Failure
- What is being tested?
- Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing) and Continued RV Pacing (Right Ventricular Pacing)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- 4 Sep 2023to 4 Sep 2027
- Phase
- Interventional
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
None listed.
Who cannot join
- Those unable to provide informed consent
- Patients under age 18
- Pregnant women
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United Kingdom12 sites, 12 recruiting
- Recruiting
Royal Papworth Hospital
Cambridge
Sharad Agarwal, sharad.agarwal@nhs.net
Sharad Agarwal
- Recruiting
St. Richard's Hospital - University Hospitals Sussex
Chichester
Mark Tanner, marktanner@nhs.net
Mark Tanner
- Recruiting
University Hospitals Coventry and Warwickshire NHS Trust,
Coventry
Michael Michael, Michael.Kuehl@uhcw.nhs.uk
Michael Kuehl
- Recruiting
Croydon University Hospital - Croydon Health Services
Croydon
Ravi Kamdar, ravi.kamdar@nhs.net
Ravi Kamdar
- Recruiting
Glenfield Hospital
Leicester
Ibrahim Mokhtar, mokhtar.ibrahim@uhl-tr.nhs.uk
Ibrahim Mokhtar
- Recruiting
Hammersmith Hospital
London
Daniel Keene, PhD
- Recruiting
King's College Hospital
London
Paul Scott, paulscott3@nhs.net
Paul Scott
- Recruiting
St Bartholomew's Hospital - Barts Health NHS Trust
London
Amal Muthumala, a.muthumala@nhs.net
Amal Muthumala
- Recruiting
Oxford University Hospitals
Oxford
Julian Ormerod, Julian.Ormerod@ouh.nhs.uk
Julian Ormerod
- Recruiting
University Hospitals Southampton
Southampton
John Paisey, john.paisey@uhs.nhs.uk
John Paisey
- Recruiting
Great Western Hospitals
Swindon
Badri Chandrasekaran, badri.chandrasekaran1@nhs.net
Badri Chandrasekaran
- Recruiting
Worthing Hospital - University Hospitals Sussex
Worthing
Marian Bencat, marian.bencat@nhs.net
Marian Bencat
About this study
Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing symptoms from pacing induced or worsened cardiomyopathy.
However, once a traditional (RV) pacemaker is implanted, development of impaired heart function does not prompt a device upgrade. Even at the end of battery life, physicians simply replace it like-for-like.
Read more
This trial tests whether such patients have better symptoms and quality of life if changed to a modern physiological pacing strategy from the traditional RV pacing approach.
In this crossover trial, participants will be upgraded to a physiological pacing strategy.
After their procedure, they will have a one-month run-in period to recover from the procedure (their pacemaker will be programmed to continued RV pacing).
They will be have 2 one-month blinded time periods, randomised to physiological pacing or right ventricular pacing alternately. They will subsequently undergo two six-month blinded randomised time periods.
Patients will document symptoms monthly on a mobile phone application or computer. At the end of each time period, they will have measurements of heart function, a walking test and quality-of-life questionnaires including the SF-36 questionnaire.
The investigators hypothesise that upgrading to physiological pacing strategies will improve patients' quality of life.
- Conditions
- Pacing-Induced Cardiomyopathy, Heart Failure
- Being tested
- Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing), Continued RV Pacing (Right Ventricular Pacing)
- Keywords
- Physiological Pacing, RV Pacing, Biventricular Pacing, Pacemaker Upgrade
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing)Device
The approach for physiological pacing upgrade will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed.
Continued RV Pacing (Right Ventricular Pacing)Device
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
| Study group | Role | What they receive |
|---|---|---|
| Physiological Pacing (Conduction System Pacing or Biventricular Pacing) | Experimental | The approach for physiological pacing will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed. Receives: Device: Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing) |
| Right Ventricular Pacing | Active comparator | Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice) Receives: Device: Continued RV Pacing (Right Ventricular Pacing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 (Short Form 36 Health Survey Questionnaire) Physical Component Summary
Measured: From date of baseline, until end of trial follow-up at fourteen months post-baseline
Secondary outcomes (12)
Left ventricular ejection fraction
(% ejection fraction)
Measured: From date of baseline, until end of trial follow-up at fourteen months
Left ventricular end systolic volume
(millilitres)
Measured: From date of baseline, until end of trial follow-up at fourteen months
Minnesota Living with Heart Failure Questionnaire
Measured: From date of baseline, until end of trial follow-up at fourteen months
Six-minute walk test
Measured in distance in metres
Measured: From date of baseline, until end of trial follow-up at fourteen months
Atrial fibrillation
(atrial fibrillation percentage burden as measured by pacemaker device - %)
Measured: From date of baseline, until end of trial follow-up at fourteen months
Patient preference based on blinded symptomatic preference
Measured: At 2 months following baseline and 14 months following baseline visit
EQ-5D Questionnaire
EQ-5D is the name of the instrument and is not an acronym. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ 'visual analogue scale' (EQ VAS).
The descriptive system is made up of 5 sections: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative (numerical) measure of health outcome that reflect the patient's own judgement. A high score on the VAS means a better outcome. A low score on the VAS means a worse outcome.
Measured: From date of baseline, until end of trial follow-up at fourteen months post-baseline visit
Patient symptoms assessed on a scale of 0-100 monthly
This questionnaire will be sent to participants on a monthly basis for the duration of the study
Measured: From date of baseline, until end of trial follow-up at fourteen months post-baseline visit
Safety endpoints
Device infections (requiring device extraction), pacing thresholds, need for lead revision or reimplantation, generator change, haematoma and pneumothorax
Measured: From device implant date, assessed up to 15 months at the end of the trial (including a one-month run-in period post-procedure prior to the first baseline visit)
SF-36 (Short Form 36 Health Survey Questionnaire) Overall Score
Measured: From date of baseline, until end of trial follow-up at fourteen months post baseline visit
SF-36 (Short Form 36 Health Survey Questionnaire) Individual Component Scores
Measured: From date of baseline, until end of trial follow-up at fourteen months post baseline visit
BNP (B-type natriuretic peptide)
B-type natriuretic peptide blood test
Measured: From date of baseline, until end of trial follow-up at fourteen months post baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start4 Sep 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion4 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacing-Induced CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Keene, PhD, Principal investigator, Imperial College LondonNandita Kaza, MRCP, Study director, Imperial College LondonMatthew Shun-Shin, PhD, Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052475
- Sponsor's protocol ID
- 23HH8156
- Acronym
- PROTECT-UP
- Status last verified
- Jun 2026
- First submitted
- 19 Sep 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No