Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades

Обзор

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.

Вмешательства

• Устройство Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing)
  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.
• Устройство Continued RV Pacing (Right Ventricular Pacing)
  Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).

Первичные конечные точки

• SF-36 (Short Form 36 Health Survey Questionnaire) Physical Component Summary [Срок оценки: From date of baseline, until end of trial follow-up at fourteen months post-baseline]

Вторичные конечные точки (12)

• Left ventricular ejection fraction [Срок оценки: From date of baseline, until end of trial follow-up at fourteen months]
• Left ventricular end systolic volume [Срок оценки: From date of baseline, until end of trial follow-up at fourteen months]
• Minnesota Living with Heart Failure Questionnaire [Срок оценки: From date of baseline, until end of trial follow-up at fourteen months]
• Six-minute walk test [Срок оценки: From date of baseline, until end of trial follow-up at fourteen months]
• Atrial fibrillation [Срок оценки: From date of baseline, until end of trial follow-up at fourteen months]
• Patient preference based on blinded symptomatic preference [Срок оценки: At 2 months following baseline and 14 months following baseline visit]
• EQ-5D Questionnaire [Срок оценки: 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 [Срок оценки: From date of baseline, until end of trial follow-up at fourteen months post-baseline visit]
• Safety endpoints [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From date of baseline, until end of trial follow-up at fourteen months post baseline visit]
• BNP (B-type natriuretic peptide) [Срок оценки: From date of baseline, until end of trial follow-up at fourteen months post baseline visit]

Критерии участия

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:

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Великобритания · 12 центров

• Royal Papworth Hospital — Cambridge
• St. Richard's Hospital - University Hospitals Sussex — Chichester
• University Hospitals Coventry and Warwickshire NHS Trust, — Coventry
• Croydon University Hospital - Croydon Health Services — Croydon
• Glenfield Hospital — Leicester
• Hammersmith Hospital — London
• King's College Hospital — London
• St Bartholomew's Hospital - Barts Health NHS Trust — London
• … и ещё 4 центра

Идентификаторы

NCT: NCT06052475 · 23HH8156

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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