Идёт набор NCT04206852

Safety and Efficacy of Balloon Pulmonary Angioplasty in China

— Наблюдательное Chronic Thromboembolic Pulmonary Hypertension

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Balloon pulmonary angioplasty.
Кому может быть актуально: Состояния в реестре: Chronic Thromboembolic Pulmonary Hypertension. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Balloon pulmonary angioplasty (BPA) is a potential treatment for non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH). The aim of this study was to evaluate the safety and efficacy of BPA in CTEPH patients not amenable to pulmonary endarterectomy(PEA) or suffered from persistent CTEPH after PEA.

Подробное описание

This study is a prospective, multi-center, long-term observational project to study the safety and efficacy of BPA. Clinical evaluation, including: functional capacity, 6-minutes walking test, biomarkers, cardiopulmonary exercise test, electrocardiography, echocardiography, haemodynamics, pulmonary angiography and lung scintigraphy was performed before the initiation therapy of BPA, and 3-12 months after last session of BPA.

we also aim to evaluate the value of FAPI in predicting the efficacy and the prognosis of patients with CTEPH who received BPA.

Вмешательства

Процедура Balloon pulmonary angioplasty
Balloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.

Первичные конечные точки

Incidence of Treatment-Emergent Adverse Events of BPA procedure. [Срок оценки: From initiation of BPA to 3-12 months after last session]
Change of Pulmonary artery pressure in mmHg caused by series of BPA. [Срок оценки: From initiation of BPA to 3-12 months after last session]
Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA. [Срок оценки: From initiation of BPA to 3-12 months after last session]
Change of cardiac index (CI) in L/m^2 caused by series of BPA. [Срок оценки: From initiation of BPA to 3-12 months after last session]
Change of World Health Organization (WHO) functional capacity classification caused by series of BPA. [Срок оценки: From initiation of BPA to 3-12 months after last session]
Change of six minutes walk distance in meter caused by series of BPA. [Срок оценки: From initiation of BPA to 3-12 months after last session]
Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA. [Срок оценки: From initiation of BPA to 3-12 months after last session]
Change of Peak VO2/kg in ml/min/kg caused by series of BPA. [Срок оценки: From initiation of BPA to 3-12 months after last session]
Change of diffusing capacity for carbon monoxide caused by series of BPA. [Срок оценки: From initiation of BPA to 3-12 months after last session]
Change of fibroblast activation protein inhibitor expression after BPA [Срок оценки: From initiation of BPA to 3-12 months after last session]

Критерии участия

Критерии включения

diagnosed with CTEPH according to ESC Guidelines (1) Mean PAP ≥ 25mmHg at rest; or if mean PAP < 25mmHg at rest, have exercise limitations from chronic thromboembolic disease (2)Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
Not amenable to pulmonary endarterectomy
Willing to provide informed consent