Efficacy and Safety of Xinyue Capsule in the Treatment of Heart Failure With Preserved Ejection Fraction

NCT06946095 | Not Yet Recruiting Phase 3

• 1 other identifier: drjihuang
• Study Type: interventional
• Target: 246
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Keywords

Heart Failure with Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• N-terminal pro-brain natriuretic peptide (NT-proBNP).

  At baseline, Weeks 12

Secondary Outcomes (9)

• Mitral Annular e' Velocity Mitral Annular e' Velocity: Mitral Annular e' Velocity:

  At baseline, Weeks 12

• Six-minute walk distance.

  At baseline, Weeks 12

• Minnesota Living with Heart Failure Questionnaire

  At baseline, Weeks 12

• PHQ-9 score

  At baseline, Weeks 12

• Average E/e' Ratio

  At baseline, Weeks 12

Study Arms (2)

Chinese patent medicine

EXPERIMENTAL

Add Xinyue Capsules to the regular western medicine treatment.

Drug: Chinese patent medicine

western medicine treatment

NO INTERVENTION

only use the regular western medicine treatment

Interventions

Chinese patent medicine DRUG

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).

Chinese patent medicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 27, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share