Efficacy and Safety of Xinyue Capsule in the Treatment of Heart Failure With Preserved Ejection Fraction: A Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 246
- 主要终点
- N-terminal pro-brain natriuretic peptide (NT-proBNP).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
排除标准
- •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.
研究组 & 干预措施
Chinese patent medicine
Add Xinyue Capsules to the regular western medicine treatment.
干预措施: Chinese patent medicine (Drug)
结局指标
主要结局
N-terminal pro-brain natriuretic peptide (NT-proBNP).
时间窗: At baseline, Weeks 12
次要结局
- Mitral Annular e' Velocity Mitral Annular e' Velocity: Mitral Annular e' Velocity:(At baseline, Weeks 12)
- Six-minute walk distance.(At baseline, Weeks 12)
- Minnesota Living with Heart Failure Questionnaire(At baseline, Weeks 12)
- PHQ-9 score(At baseline, Weeks 12)
- Average E/e' Ratio(At baseline, Weeks 12)
- Left Atrial Volume Index (LAVI)(At baseline, Weeks 12)
- Tricuspid Regurgitation Peak Velocity (TR Vmax)(At baseline, Weeks 12)
- Left Ventricular Eccentricity Index (LVEI)(At baseline, Weeks 12)
- GAD-7 scores(At baseline, Weeks 12)