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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2025000874

Enrollment

Unknown

Registered

2025-04-28

Start date

2025-05-20

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with preserved ejection fraction (HFpEF)

Interventions

Test group:In addition to conventional Western pharmacological treatment Xinyue Capsule (2 capsules three times daily) will be administered.

Control group:Conventional Western pharmacological treatment.

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: a. Age = 18 years and signed informed consent provided; b. Presence of symptoms such as dyspnea (including exertional dyspnea paroxysmal nocturnal dyspnea orthopnea) fatigue poor appetite and bilateral lower limb edema; c. Left Ventricular Ejection Fraction (LVEF) = 50% and meeting at least one of the following criteria: 1) NT-proBNP = 125 ng/L (sinus rhythm) or NT-proBNP = 365 ng/L (atrial fibrillation); 2) Echocardiographic measurement of E/e' ratio = 15;

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
N-terminal pro-brain natriuretic peptide (NT-proBNP).;	—

Secondary

Measure	Time frame
Six-minute walk distance;peak tricuspid regurgitation velocity;E/e' ratio;Depression Screening Scale (PHQ-9);left atrial volume index;Minnesota Living with Heart Failure Questionnaire;Generalized Anxiety Disorder 7-item Scale (GAD-7);mitral annular e velocity;left ventricular eccentricity index;	—

Countries

China

Contacts

Public ContactHuang Ji

Beijing Anzhen Hospital Affiliated to Capital Medical University

drjihuang@163.com15810291548

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026