Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation

Официальное название

Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation - Combined Cross-sectional and Prospective, Multi-centre, Randomized, Parallel-group Clinical Trial

Обзор

Tetralogy of Fallot (ToF) is a congenital heart defect with four major features including right ventricular outflow tract obstruction. About 25 children are born with this condition in Denmark every year. Corrective surgery is usually performed within the first year. In 50 % of patients, enlargement with a patch is necessary to achieve relief of the outflow tract obstruction. This however results in severe pulmonary regurgitation, which eventually leads to volume overload, right ventricular dysfunction and arrhythmia. To avoid these late complications, pulmonary valve replacement with a prosthesis if performed when patients meet the current guideline criteria. Most patients meet the guideline criteria for revalving when they are between 20 and 30 years of age. The current guidelines however, are based solely on retrospective studies and novel research reveals that in more than 50 % of patients who are treated according to current practice, right ventricular volumes and function as well as exercise capacity and burden of arrhythmia do not normalize or improve. 500 patients with ToF will be enrolled in a multicentre, cross-sectional study, which will yield information about the long-term outcomes after initial repair of ToF, as well as suggestions about the optimal timing for re-valving. Among patients included in the cross-sectional study, 120 patients with free pulmonary regurgitation, will be randomized evenly for early or later re-valving with at least 10-years of follow-up, for evaluation of long-term efficacy and safety of early re-valving.

Вмешательства

• Процедура Pulmonary valve replacement
  Surgical implantation of an adult-sized (≥ 18 mm) homograft or Contegra graft as right ventricle-to-pulmonary artery conduit under cardiopulmonary bypass through a sternotomy.

Первичные конечные точки

• Mean right ventricular end-diastolic volume indexed to body surface area [Срок оценки: 3 years after randomization]
• Rate of deceased patients (all-cause mortality) and total number of patients [Срок оценки: 3 years after randomization]

Вторичные конечные точки (12)

• Right ventricular end-systolic volume indexed to body surface area [Срок оценки: Assessed once every year for 10 years after randomization]
• Right ventricular ejection fraction [Срок оценки: Assessed once every year for 10 years after randomization]
• Left ventricular end-diastolic volume indexed to body surface area [Срок оценки: Assessed once every year for 10 years after randomization]
• Left ventricular end-systolic volume indexed to body surface area [Срок оценки: Assessed once every year for 10 years after randomization]
• Left ventricular ejection fraction [Срок оценки: Assessed once every year for 10 years after randomization]
• Rate of patients with procedure-related bleeding and total number of patients [Срок оценки: 30 days after surgery]
• Rate of patients with procedure-related acute kidney injury and total number of patients. [Срок оценки: 30 days after surgery]
• Composite-rate of all-cause mortality and disabling stroke [Срок оценки: Assessed once every year for 10 years after randomization]
• Rate of patients deceased due to cardiovascular causes and total number of patients [Срок оценки: Assessed once every year for 10 years after randomization]
• Composite-rate of patients who suffer from disabling strokes or transient ischemic attacks [Срок оценки: Assessed once every year for 10 years after randomization]
• Mean New York Heart Association class [Срок оценки: Assessed once every year for 10 years after randomization]
• Mean health-associated quality of life (adults) [Срок оценки: Assessed once every year for 10 years after randomization]

Критерии участия

Критерии включения

• ToF with pulmonary stenosis repaired with a TAP within the first two years of life.
• RVOT anatomy is suitable for implantation of an adult sized conduit ( 18 mm homograft or Contegra graft) as assessed by MRI.

Критерии исключения

• ToF with pulmonary atresia, ToF with common atrioventricular canal, ToF with absent pulmonary valve syndrome, major aortopulmonary collateral arteries and other significant associated anomalies.
• Palliation with a shunt (Blalock-Taussig or central) at any time.
• The patient is symptomatic.
• Sustained supraventricular or ventricular arrhythmia.
• RVEDVi > 140 mL/m2 as assessed by MRI (appendix 1).
• RVESVi > 60 mL/m2 as assessed by MRI.
• RVEF < 50 % as assessed by MRI.
• Moderate or severe tricuspid regurgitation as assessed by echocardiography or MRI.
• Significant residual lesions requiring intervention (e.g. ventricular septal defect, aortic regurgitation, branch pulmonary artery stenosis).
• Co-morbidity preventing exercise testing (e.g. genetics, neuro-cognitive dysfunction, physical disability).
• Contraindication for MRI (e.g. permanent pacemaker, intra-cardiac defibrillator, intracranial ferro-magnetic device).
• Pregnancy at time of inclusion.
• Age < 12 or unable to comply with instructions given during MRI or exercise testing.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Дания · 3 центра

• Aarhus University Hospital — Aarhus
• Rigshospitalet — Copenhagen
• Odense University Hospital — Odense

Идентификаторы

NCT: NCT04084132 · VD-2018-512

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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