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Набор скоро начнётся NCT07374302

Riociguat in Triple Therapy for Pulmonary Arterial Hypertension in Real-World Practice

— Наблюдательное Pulmonary Arterial 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Pulmonary Arterial 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Официальное название

REAPPRAISED: Riociguat in Triple Therapy for Pulmonary Arterial Hypertension - A Single-Center Retrospective Study With Composite Endpoint Evaluation

Обзор

Pulmonary arterial hypertension is a rare and serious disease that can lead to heart failure and early death despite modern treatments. Many patients are treated with a combination of medications targeting different disease pathways, but some continue to have an inadequate response. Riociguat is a medication that acts on the nitric oxide pathway and may be beneficial in patients who do not respond well to phosphodiesterase-5 inhibitors. In routine clinical practice, some patients receiving triple therapy switch from a phosphodiesterase-5 inhibitor to riociguat. The REAPPRAISED study evaluates outcomes in patients with pulmonary arterial hypertension who switched to riociguat while receiving triple therapy. This observational study uses data from routine clinical care and does not involve any experimental treatment. The results may help improve understanding of the effectiveness and safety of this treatment strategy in real-world practice.

Подробное описание

Pulmonary arterial hypertension (PAH) is a progressive disease associated with high morbidity and mortality despite the use of combination therapy. Triple therapy including an endothelin receptor antagonist, a prostacyclin pathway agent, and a phosphodiesterase-5 inhibitor is commonly used; however, a subset of patients shows an inadequate clinical response.

Riociguat is a soluble guanylate cyclase stimulator that increases cyclic GMP through both nitric oxide-dependent and nitric oxide-independent mechanisms. Switching from a phosphodiesterase-5 inhibitor to riociguat has shown clinical benefit in selected patients, but data in real-world settings and in patients already receiving triple therapy remain limited.

REAPPRAISED is a single-center, retrospective, observational study conducted in a pulmonary hypertension referral center. The study evaluates clinical outcomes following the switch from a phosphodiesterase-5 inhibitor to riociguat in patients with PAH receiving triple therapy. All treatment decisions were made by the treating physicians as part of routine clinical care. No study-mandated interventions or treatment assignments were performed, and data were obtained from medical records.

Первичные конечные точки

  • Composite Clinical Outcome at 6 Months [Срок оценки: 6 months (24±8 weeks) after switch]
Вторичные конечные точки (5)
  • Persistence and Time to Discontinuation of Riociguat [Срок оценки: Up to 6 months]
  • Safety Outcomes [Срок оценки: Up to 6 months]
  • Health Care Utilization [Срок оценки: 6 months before and 6 months after switch]
  • Functional Changes [Срок оценки: From baseline to 6 months]
  • Risk Stratification (COMPERA 2.0) [Срок оценки: From baseline to 6 months]

Критерии участия

Критерии включения

  • Adults aged 18 years or older.
  • Confirmed diagnosis of pulmonary arterial hypertension (Group 1).
  • Treatment with triple therapy including an endothelin receptor antagonist, a prostacyclin pathway agent, and a phosphodiesterase-5 inhibitor for at least 12 weeks.
  • Switch from a phosphodiesterase-5 inhibitor to riociguat as part of routine clinical care.
  • Availability of minimum data to assess the primary outcome at 6 months.

Критерии исключения

  • Concomitant use of phosphodiesterase-5 inhibitors and riociguat.
  • Inability to confirm vital status or hospitalization outcomes within 6 months.
  • Participation in an interventional clinical trial that mandated the treatment switch.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07374302 · SGP 27906

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗