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

Overview

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.

Interventions

• Drug Chinese patent medicine
  This study aims to investigate whether the addition of Xinyue Capsule to conventional Western medical therapy significantly improves cardiac function and reduces the level of heart failure biomarker NT-proBNP in patients with Heart Failure with Preserved Ejection Fraction (HFpEF).

Primary outcome measures

• N-terminal pro-brain natriuretic peptide (NT-proBNP). [Time frame: At baseline, Weeks 12]

Secondary outcome measures (9)

• Mitral Annular e' Velocity Mitral Annular e' Velocity: Mitral Annular e' Velocity: [Time frame: At baseline, Weeks 12]
• Six-minute walk distance. [Time frame: At baseline, Weeks 12]
• Minnesota Living with Heart Failure Questionnaire [Time frame: At baseline, Weeks 12]
• PHQ-9 score [Time frame: At baseline, Weeks 12]
• Average E/e' Ratio [Time frame: At baseline, Weeks 12]
• Left Atrial Volume Index (LAVI) [Time frame: At baseline, Weeks 12]
• Tricuspid Regurgitation Peak Velocity (TR Vmax) [Time frame: At baseline, Weeks 12]
• Left Ventricular Eccentricity Index (LVEI) [Time frame: At baseline, Weeks 12]
• GAD-7 scores [Time frame: At baseline, Weeks 12]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06946095 · drjihuang

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗