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Идёт набор NCT06922240

Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)

Фаза III С лечением 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: Riociguat, Routine Treatment.
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
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Официальное название

Effect of Discontinuation of Riociguat on Right Heart Function in Patients With CTEPH After Combination Therapy

Обзор

Riociguat and balloon pulmonary angioplasty (BPA) are established standard-of-care interventions for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) with comparable evidence levels. However, the optimal combined treatment strategy remains unclear. Specifically, there is no consensus on whether riociguat should be continued long-term after achieving hemodynamic stability with BPA. Additionally, the long-term effects of riociguat discontinuation on right ventricular (RV) structure and function remain poorly characterized, particularly due to the lack of comprehensive noninvasive evaluations integrating cardiac magnetic resonance (CMR) and echocardiography. This prospective study aims to determine the hemodynamic impact of riociguat discontinuation in inoperable CTEPH patients who have achieved BPA treatment endpoints using right heart catheterization (RHC). Evaluate RV remodeling and functional changes after riociguat cessation through multimodal noninvasive imaging (CMR, echocardiography). Assess safety outcomes and identify potential rebound pulmonary hypertension or decompensated RV dysfunction associated with riociguat withdrawal.

Вмешательства

  • Препарат Riociguat
    On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc., continue oral administration of riociguat for treatment.
  • Препарат Routine Treatment
    On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc, and stop taking riociguat

Первичные конечные точки

  • Change from Baseline in the Cardiac Output at 6 Months. [Срок оценки: Baseline and 6-month follow-up]
Вторичные конечные точки (5)
  • Change from Baseline in the Pulmonary Vascular Resistance at 6 Months. [Срок оценки: Baseline and 6-month follow-up]
  • Change from Baseline in the concentration of NT-proBNP at 6 Months. [Срок оценки: Baseline and 6-month follow-up]
  • Change from Baseline in the 6-minute walking distance at 6 Months. [Срок оценки: Baseline, 3-month follow-up, and 6-month follow-up]
  • All-cause mortality [Срок оценки: From the baseline to the completion follow-up,an average of 6 months]
  • Combined incidence of all-cause death, re-hospitalization or disability/incapacity events due to clinical exacerbation of pulmonary hypertension [Срок оценки: From the baseline to the completion follow-up,an average of 6 months]

Критерии участия

Критерии включения

  • Age ≥18 years old
  • CTEPH was diagnosed and one of the following three factors was met: Pulmonary endarterectomy was technically impossible; Pulmonary endarterectomy is technically feasible, but the risk-benefit ratio is poor; Residual/recurrent pulmonary hypertension after pulmonary endarterectomy
  • Subjects had been treated with BPA and had received a stable dose of riociguat for ≥12 weeks
  • mPAP < 30mmHg
  • Male subjects and female subjects of reproductive age are required to use effective contraception for at least 28 days after signing the informed consent form. Male subjects are not allowed to donate sperm and female subjects are not allowed to breastfeed.
  • Subjects voluntarily sign written informed consent

Критерии исключения

  • Severe hepatic and renal insufficiency (Child-Pugh Grade C/creatinine clearance < 30ml/min·1.73m²)
  • The presence of severe infectious disease or severe bleeding tendency
  • Combined with pulmonary hypertension of other types than CTEPH
  • Other pulmonary hypertension targeting drugs are being used
  • The expected survival time with cancer or other diseases is less than 6 months
  • Pregnancy, lactation
  • Subjects are currently participating in an interventional clinical trial
  • In the investigator's judgment, a subject's medical abnormality, physical condition, or medical history may affect his or her ability to participate in or complete the study

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

Китай · 3 центра
  • Beijing Chao-Yang Hospital — Пекин
  • China-Japan Friendship Hospital — Пекин
  • Beijing Anzhen Hospital — Пекин

Идентификаторы

NCT: NCT06922240 · BRWEP2024W112030108

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗