Clinical trial NCT06052475: Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
Official title: Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pacing-Induced Cardiomyopathy
Heart Failure
Keywords: Physiological Pacing
RV Pacing
Biventricular Pacing
Pacemaker Upgrade
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

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.


Eligibility criteria: Patients with an RV pacemaker and LVEF 35-50% and a high burden of right ventricular pacing (\>40%) who are clinically indicated for a cardiac resynchronisation therapy upgrade procedure and:

1. EF reduced by \>5% of increase in LVESV by 10ml since implant
2. NT-proBNP \>250ng/L in sinus rhythm
3. NT-proBNP \> 750 Ng/L if AF
4. Left atrial volume index \> 30ml/m2
5. Regular loop diuretics prescribed
6. Decline in daily patient activity by \>1 hour per day since implant
7. Decrease in device measured thoracic impedance
8. Patient reported decline in functional class or exercise tolerance

Exclusion Criteria:

* Those unable to provide informed consent
* Patients under age 18
* Pregnant women

Primary outcomes:
measure: SF-36 (Short Form 36 Health Survey Questionnaire) Physical Component Summary
timeFrame: From date of baseline, until end of trial follow-up at fourteen months post-baseline
Secondary outcomes:
measure: Left ventricular ejection fraction
timeFrame: From date of baseline, until end of trial follow-up at fourteen months
measure: Left ventricular end systolic volume
timeFrame: From date of baseline, until end of trial follow-up at fourteen months
measure: Minnesota Living with Heart Failure Questionnaire
timeFrame: From date of baseline, until end of trial follow-up at fourteen months
measure: Six-minute walk test
timeFrame: From date of baseline, until end of trial follow-up at fourteen months
measure: Atrial fibrillation
timeFrame: From date of baseline, until end of trial follow-up at fourteen months
measure: Patient preference based on blinded symptomatic preference
timeFrame: At 2 months following baseline and 14 months following baseline visit
measure: EQ-5D Questionnaire
timeFrame: From date of baseline, until end of trial follow-up at fourteen months post-baseline visit
measure: Patient symptoms assessed on a scale of 0-100 monthly
timeFrame: From date of baseline, until end of trial follow-up at fourteen months post-baseline visit
measure: Safety endpoints
timeFrame: 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)
measure: SF-36 (Short Form 36 Health Survey Questionnaire) Overall Score
timeFrame: From date of baseline, until end of trial follow-up at fourteen months post baseline visit
measure: SF-36 (Short Form 36 Health Survey Questionnaire) Individual Component Scores
timeFrame: From date of baseline, until end of trial follow-up at fourteen months post baseline visit
measure: BNP (B-type natriuretic peptide)
timeFrame: From date of baseline, until end of trial follow-up at fourteen months post baseline visit
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
city: Chichester
country: United Kingdom
facility: St. Richard's Hospital - University Hospitals Sussex
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust,
city: Croydon
country: United Kingdom
facility: Croydon University Hospital - Croydon Health Services
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital - Barts Health NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
city: Southampton
country: United Kingdom
facility: University Hospitals Southampton
city: Swindon
country: United Kingdom
facility: Great Western Hospitals
city: Worthing
country: United Kingdom
facility: Worthing Hospital - University Hospitals Sussex
Study officials:
affiliation: Imperial College London
name: Daniel Keene, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Nandita Kaza, MRCP
role: STUDY_DIRECTOR
affiliation: Imperial College London
name: Matthew Shun-Shin, PhD
role: STUDY_DIRECTOR
References: