보존 된 방출 분획으로 심부전 치료에서 Xinyue 캡슐의 효능 및 안전성

Inclusion Criteria:

1. Age ≥ 18 years, and signed informed consent provided;
2. Presence of symptoms such as dyspnea (including exertional dyspnea, paroxysmal nocturnal dyspnea, orthopnea), fatigue, poor appetite, and bilateral lower limb edema;

3. 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);

Exclusion Criteria:

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