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Идёт набор NCT05140525

Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH

Фаза III С лечением CTEPH

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: Macitentan Tablets, Riociguat, balloon pulmonary angioplasty.
Кому может быть актуально
Состояния в реестре: CTEPH. 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
США
Следующий шаг
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Официальное название

Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension

Обзор

The main goal of this study is to determine the effects of combination medical therapy (Riociguat and Macitentan) and balloon pulmonary angioplasty (BPA) on hemodynamics and right ventricular (RV) function (including advanced assessments of RV-pulmonary artery (PA) coupling from invasive hemodynamics) in participants with inoperable or post-PTE residual CTEPH.

Подробное описание

Recent presented but unpublished results from trials of BPA vs riociguat for inoperable CTEPH (NCT02634203) have demonstrated that BPA provides a more significant hemodynamic benefit than medical therapy. The investigators hypothesize that participants who are treated with upfront combination medical therapy followed by BPA will have significant improvements in their hemodynamics and RV-PA coupling that can be monitored over time.

Вмешательства

  • Препарат Macitentan Tablets
    10 mg oral once daily
  • Препарат Riociguat
    1 mg to 2.5mg oral three times daily
  • Устройство balloon pulmonary angioplasty
    on hemodynamics and RV function (including advanced assessments of RV-PA coupling

Первичные конечные точки

  • Change in end-systolic elastance (Ees) divided by arterial elastance (Ea) (Ees/Ea) at three time points: Baseline, Timepoint 1 and Timepoint 2. [Срок оценки: Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline)]
Вторичные конечные точки (5)
  • Change in six-minute walk distance (6MWD) in meters. [Срок оценки: Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline)]
  • Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) in picogram/milliliters. [Срок оценки: Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline)]
  • Change in Cardiac index as measured by liters per minute per meters squared at right heart catheterization. [Срок оценки: Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline)]
  • Change in pulmonary vascular resistance as measured by Wood units at right heart catheterization. [Срок оценки: Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline)]
  • Change in right atrial pressure as measured by millimeters of mercury at right heart catheterization. [Срок оценки: Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline)]

Критерии участия

Критерии включения

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

  • Age ≥ 18 years' old
  • Diagnosis of CTEPH
  • Not a candidate for PTE
  • Candidate for BPA based on suitable anatomy and disease burden
  • Treatment-naïve (no CTEPH or pulmonary arterial hypertension (PAH)-specific medical therapies) with plans for initiation of CTEPH/PAH-specific medical therapy and treatment with BPA.
  • Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed).

Критерии исключения

  • Subjects presenting with any of the following will not be included in the trials:
  • Moderate to severe heart disease (LVEF < 45% or severe LV Hypertrophy)
  • Sarcoidosis
  • Active cancer
  • Sickle cell anemia
  • Liver disease (Childs-Pugh class C)
  • Prisoners
  • Pregnant, planning pregnancy or lactating
  • Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
  • Contraindication to riociguat or macitentan
  • Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Duke University Medical Center — Durham

Идентификаторы

NCT: NCT05140525 · Pro00105903

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗