NCT06052475 Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
| NCT ID | NCT06052475 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Pacing-Induced Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 155 participants |
| Start Date | 2023-09-04 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 155 participants in total. It began in 2023-09-04 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Daniel Keene, PhD
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT06052475 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pacing-Induced Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06052475 currently recruiting?
Yes, NCT06052475 is actively recruiting participants. Contact the research team at a.khalil@imperial.ac.uk for enrollment information.
Where is the NCT06052475 trial being conducted?
This trial is being conducted at Cambridge, United Kingdom, Chichester, United Kingdom, Coventry, United Kingdom, Croydon, United Kingdom and 8 additional locations.
Who is sponsoring the NCT06052475 clinical trial?
NCT06052475 is sponsored by Imperial College London. The principal investigator is Daniel Keene, PhD at Imperial College London. The trial plans to enroll 155 participants.