Clinical trial NCT06946095: Efficacy and Safety of Xinyue Capsule in the Treatment of Heart Failure With Preserved Ejection Fraction
Official title: Efficacy and Safety of Xinyue Capsule in the Treatment of Heart Failure With Preserved Ejection Fraction: A Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Heart Failure
Keywords: Heart Failure with Preserved Ejection Fraction
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: N-terminal pro-brain natriuretic peptide (NT-proBNP).
timeFrame: At baseline, Weeks 12
Secondary outcomes:
measure: Mitral Annular e' Velocity Mitral Annular e' Velocity: Mitral Annular e' Velocity:
timeFrame: At baseline, Weeks 12
measure: Six-minute walk distance.
timeFrame: At baseline, Weeks 12
measure: Minnesota Living with Heart Failure Questionnaire
timeFrame: At baseline, Weeks 12
measure: PHQ-9 score
timeFrame: At baseline, Weeks 12
measure: Average E/e' Ratio
timeFrame: At baseline, Weeks 12
measure: Left Atrial Volume Index (LAVI)
timeFrame: At baseline, Weeks 12
measure: Tricuspid Regurgitation Peak Velocity (TR Vmax)
timeFrame: At baseline, Weeks 12
measure: Left Ventricular Eccentricity Index (LVEI)
timeFrame: At baseline, Weeks 12
measure: GAD-7 scores
timeFrame: At baseline, Weeks 12
Other outcomes:
Locations:
Study officials:
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