Идёт набор NCT07001800

Ataciguat for Slowing the Progression of Moderate Calcific Aortic Valve Stenosis: A Randomized, Placebo Controlled Study

Фаза II / Фаза III С лечением Moderate Aortic Valve Stenosis

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: Ataciguat, Placebo.
Кому может быть актуально: Состояния в реестре: Moderate Aortic Valve Stenosis. Базовые параметры: от 50 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, Канада
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

A Phase 2b/3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants With Moderate Calcific Aortic Valve STenosis

Обзор

The purpose of this study is to evaluate if ataciguat slows the progression of moderate calcific aortic valve stenosis in adults.

Подробное описание

This study will be conducted in two parts: Part A and Part B. The purpose of Part A is to investigate whether ataciguat slows the progression of aortic valve calcium (AVC) deposition in adults with moderate calcific aortic valve stenosis (CAVS). The safety, tolerability, and pharmacokinetics of ataciguat will also be evaluated. Approximately 132 participants will be enrolled in Part A. Enrollment in Part B will begin once enrollment in Part A is complete. The purpose of Part B is to investigate whether ataciguat slows the rate of aortic valve area (AVA) loss and to evaluate the effect of ataciguat on peak oxygen consumption (VO2) in participants with moderate CAVS. The safety and tolerability of ataciguat will also be evaluated. Approximately 1144 participants will be enrolled in Part B.

Вмешательства

Препарат Ataciguat
Ataciguat will be administrated daily for up to 156 weeks
Препарат Placebo
Placebo will be administrated daily for up to 156 weeks

Первичные конечные точки

(Part A) Change in Aortic Valve Calcium (AVC) score as assessed by non-contrast CT from baseline to Week 24 [Срок оценки: Week 24]
(Part B Dual-Primary) Percent change in Aortic Valve Area (AVA) as measured by echocardiogram from baseline to Week 48 [Срок оценки: Week 48]
(Part B Dual-Primary) Change in peak VO2 by CPET from baseline to Week 48 [Срок оценки: Week 48]

Вторичные конечные точки (8)

(Part A) Correlation in the change in AVC as assessed by non-contrast CT and change in VO2 at Week 48 [Срок оценки: Week 48]
(Part A) Change in VO2 from baseline to Week 48 [Срок оценки: Week 48]
Change in left ventricular diastolic function as assessed by E/e' from baseline to Week 48 [Срок оценки: Week 48]
(Part A) Change in Left Ventricular Mass Index (LVMI) from baseline to Week 48 [Срок оценки: Week 48]
(Part A) Change in Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) from baseline to Week 48 [Срок оценки: Week 48]
(Part B) Change in AVC score as assessed by non-contrast CT from baseline to Week 48 [Срок оценки: Week 48]
(Part B) Time to decision to proceed with TAVR/SAVR or all-cause death [Срок оценки: Week 158]
(Part B) Percentage of participants with progression to AVA <1.0cm2 at Week 48 [Срок оценки: Week 48]

Критерии участия

Критерии включения

Adult male or female at least 50 years of age
Has moderate CAVS as defined by:

An AVA of ≥1.0 cm2 to ≤1.50 cm2
An AVC score between >300 to 1200 Agatston units (AU) for women and between >300 to 2000 AU for men
Has a left ventricular ejection fraction (EF) of ≥45% at the time of Screening as determined by the echocardiography Imaging Core Laboratory
For participants in CPET sub-study in Part A and all participants in Part B: If on beta blockade, the dose must be stable for at least 90 days prior to the Screening Visit with no anticipated changes during the study

Критерии исключения

For participants in the CPET sub-study in Part A and all participants in Part B: Has any medical or physical condition that, in the Investigator's opinion, could lead to an inability to complete Protocol-required CPET procedures (eg, pulmonary disease, joint, leg, hip, back conditions that limit physical activity, or other absolute contraindications for CPET)
Anticipated or planned prior aortic valve replacement, repair, surgery, or intervention in the next 6 months
Has moderate, moderate-to-severe, or severe (Grade 2 or higher) mitral stenosis, mitral regurgitation, and/or aortic regurgitation
Has suspected or known congenital aortic valve disease including bicuspid aortic valve
New York Heart Association (NYHA) Class IV heart failure symptoms and/or requires continuous inotropes
Has history of hypertrophic, genetic/familial cardiomyopathy or cardiomyopathy related to amyloid or sarcoid
Has untreated obstructive coronary artery disease or anticipating coronary stenting surgery
Abnormal electrocardiogram (ECG) results or long-standing persistent or permanent atrial fibrillation

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

Здоровые добровольцы: Нет