Status:
NOT_YET_RECRUITING
Efficacy and Safety of Xinyue Capsule in the Treatment of Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
Beijing Anzhen Hospital
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- 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);
Exclusion
- 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.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT06946095
Start Date
May 20 2025
End Date
October 31 2027
Last Update
April 27 2025
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