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Набор скоро начнётся NCT07668739

Efficacy of Verciguat in TR and RV Failure

Фаза IV С лечением HFrEF Tricuspid Regurgitation (TR)

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: Vericiguat.
Кому может быть актуально
Состояния в реестре: HFrEF, Tricuspid Regurgitation (TR). Базовые параметры: от 19 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
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy of Vericiguat in HFrEF Patients With Coexisting Severe Tricuspid Regurgitation and Right Heart Failure; Multicenter Pragmatic Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if the drug vericiguat works to improve right heart function in patients with worsening heart failure who have reduced left ventricular function. It will also examine the effects of the drug on tricuspid regurgitation (TR) and overall clinical outcomes. The main questions it aims to answer are: Does vericiguat improve right ventricular (RV) function and reduce tricuspid regurgitation (TR)? Does vericiguat reduce the risk of major adverse cardiovascular events (MACE), such as heart failure hospitalizations and cardiovascular death? Does vericiguat improve participants' exercise capacity, quality of life, and renal function? Researchers have previously seen the benefits of vericiguat in the large-scale VICTORIA trial for worsening heart failure, and it is hypothesized that improvements in right heart function play a key role. This study aims to confirm these specific benefits. Participants will: Take vericiguat as prescribed during the study period. Undergo echocardiograms at enrollment and at 9 months to assess right heart function. Complete questionnaires (KCCQ-12) and walking tests (6MWT) to evaluate quality of life and exercise capacity. Provide blood samples to monitor NTproBNP levels and renal function (creatinine).

Вмешательства

  • Препарат Vericiguat
    Participants will start vericiguat at 2.5 mg once daily, and the dose will be gradually uptitration every 2 weeks to a target dose of 10 mg once daily, depending on tolerability.

Первичные конечные точки

  • NTproBNP [Срок оценки: NTproBNP will be assessed from enrollment to the end of treatment at baseline, 3 and 9 months.]
  • Echocardiographic RV function parameters [Срок оценки: From enrollment to the end of treatment at baseline and 9 months]
Вторичные конечные точки (4)
  • Composite endpoint of Major Adverse Cardiovascular Events (MACE) [Срок оценки: From enrollment to the end of treatment at 9 months]
  • Exercise capacity and quality of life [Срок оценки: From enrollment to the end of treatment at baseline and 9 months]
  • 6-Minute Walk Test (6MWT distance) [Срок оценки: From enrollment to the end of treatment at baseline and 9 months]
  • Renal Function [Срок оценки: from enrollment to the end of treatment at baseline, 3 and 9 months.]

Критерии участия

Критерии включения

  • Age more than 19 years old
  • right ventricular malfunction confirmed with EKG data or cardiac MRI
  • chronic heart failure with LVEF<45%
  • Patients Who administrated standard treatment of Heart Failur for over the 4 weeks
  • NTproBNP >1000, NTproBNP >1600 with atrial fibrillation or The patient who recently experienced worsening heart failure(Recent hospitalization for worsening heart failure or outpatient administration of intravenous diuretics)
  • Tricuspid regurgitation of greater than moderate severity was confirmed by echocardiogram
  • Subject who provided voluntary informed consent to participate in the study
  • Patients who have not been administered vericiguat within the last 6 months

Критерии исключения

  • Patients with a systolic blood pressure (SBP) < 100 mmHg
  • Patients currently treated with other sGC stimulators (including vericiguat) or phosphodiesterase-5 (PDE5) inhibitors
  • Moderate-to-severe right ventricular (RV) failure requiring surgical intervention
  • Patients who are currently pregnant or of childbearing potential

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
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Daejeon St.Mary's Hospital — Daejeon

Публикации

  • Metra M, Tomasoni D, Adamo M, Bayes-Genis A, Filippatos G, Abdelhamid M, Adamopoulos S, Anker SD, Antohi L, Bohm M, Braunschweig F, Gal TB, Butler J, Cleland JGF, Cohen-Solal A, Damman K, Gustafsson F, Hill L, Jankowska EA, Lainscak M, Lund LH, McDonagh T, Mebazaa A, Moura B, Mullens W, Piepoli M, Ponikowski P, Rakisheva A, Ristic A, Savarese G, Seferovic P, Sharma R, Tocchetti CG, Yilmaz MB, Vita PMID 37208936
  • Hashimoto T, Yoshitake T, Suenaga T, Yamamoto S, Fujino T, Shinohara K, Matsushima S, Ide T, Kinugawa S, Abe K. Effectiveness of Vericiguat on right ventricle to pulmonary artery uncoupling associated with heart failure with reduced ejection fraction. Int J Cardiol. 2024 Nov 15;415:132441. doi: 10.1016/j.ijcard.2024.132441. Epub 2024 Aug 10. PMID 39134125

Идентификаторы

NCT: NCT07668739 · DC26MIDI0013

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗