Efficacy and Safety of Xinyue Capsule in the Treatment of Heart Failure With Preserved Ejection Fraction

Официальное название

Efficacy and Safety of Xinyue Capsule in the Treatment of Heart Failure With Preserved Ejection Fraction: A Clinical Study

Обзор

The purpose of this study is to evaluate the effect of Xinyue Capsule in the improvement cardiac function and reduction the level of heart failure biomarker NT-proBNP in patients suffering from HF with an ejection fraction greater than or equal to 50%. Researchers will also collect information on how much the heart disease has impact on patient's lives, and how well Xinyue Capsule treatment is tolerated. The study plans to enroll 246 male and female patients of the age of 18 years and above suffering from heart failure with ejection fraction greater than or equal to 50%. Participants will take the study product as oral tablet with a dose 0.6 g Tid daily. Study duration will be up to 12 weeks.

Вмешательства

• Препарат Chinese patent medicine
  This study aims to investigate whether the addition of Xinyue Capsule to conventional Western medical therapy significantly improves cardiac function and reduces the level of heart failure biomarker NT-proBNP in patients with Heart Failure with Preserved Ejection Fraction (HFpEF).

Первичные конечные точки

• N-terminal pro-brain natriuretic peptide (NT-proBNP). [Срок оценки: At baseline, Weeks 12]

Вторичные конечные точки (9)

• Mitral Annular e' Velocity Mitral Annular e' Velocity: Mitral Annular e' Velocity: [Срок оценки: At baseline, Weeks 12]
• Six-minute walk distance. [Срок оценки: At baseline, Weeks 12]
• Minnesota Living with Heart Failure Questionnaire [Срок оценки: At baseline, Weeks 12]
• PHQ-9 score [Срок оценки: At baseline, Weeks 12]
• Average E/e' Ratio [Срок оценки: At baseline, Weeks 12]
• Left Atrial Volume Index (LAVI) [Срок оценки: At baseline, Weeks 12]
• Tricuspid Regurgitation Peak Velocity (TR Vmax) [Срок оценки: At baseline, Weeks 12]
• Left Ventricular Eccentricity Index (LVEI) [Срок оценки: At baseline, Weeks 12]
• GAD-7 scores [Срок оценки: At baseline, Weeks 12]

Критерии участия

Критерии включения

• Age ≥ 18 years, and signed informed consent provided;
• Presence of symptoms such as dyspnea (including exertional dyspnea, paroxysmal nocturnal dyspnea, orthopnea), fatigue, poor appetite, and bilateral lower limb edema;
• Left Ventricular Ejection Fraction (LVEF) ≥ 50%, and meeting at least one of the following criteria:

• NT-proBNP ≥ 125 ng/L (sinus rhythm) or NT-proBNP ≥ 365 ng/L (atrial fibrillation);

Критерии исключения

• Usage of Xinyue Capsule or other Chinese patent medicines/herbal remedies aimed at alleviating heart failure symptoms or biomarkers within the past 90 days;
• Known intolerance or significant allergic reaction to Xinyue Capsule;
• Occurrence of cardiovascular adverse events within the past 90 days;
• Acute decompensated heart failure, life-threatening arrhythmias, acute myocardial infarction, or cardiogenic shock;
• Heart failure secondary to pulmonary hypertension, anemia, thyroid disorders, chronic obstructive pulmonary disease, or musculoskeletal disorders;
• Presence of cardiac amyloidosis, storage diseases (hemochromatosis, glycogen storage disease), severe valvular heart disease, severe infections, malignancies, or significant hepatic or renal insufficiency.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06946095 · drjihuang

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗