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Evaluating ShengXian-QuYu Decoction for Heart Failure Patients

Effects of "ShengXian-QuYu Decoction" on Quality of Life, Symptoms, and Biomarkers in Heart Failure Patients With Reduced and Mildly Reduced Ejection Fraction: a Pragmatic, Nationwide, Multicenter, Parallel Group, Randomized, Double-Blind, Placebo-Controlled Trial

PHASE4 · China-Japan Friendship Hospital · NCT05583773

This study is testing whether ShengXian-QuYu Decoction can improve the quality of life and symptoms for people with heart failure who have reduced heart function.

Quick facts

PhasePHASE4
Study typeInterventional
Enrollment336 (estimated)
Ages18 Years and up
SexAll
SponsorChina-Japan Friendship Hospital (other)
Locations26 sites (Beijing, Beijing Municipality and 25 other locations)
Trial IDNCT05583773 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effects of ShengXian-QuYu Decoction on the quality of life, symptoms, and biomarkers in patients with heart failure who have reduced and mildly reduced ejection fraction. It is a multicenter, randomized, double-blind, placebo-controlled study that will compare the decoction to a placebo, administered twice daily alongside standard care. The study will analyze various subgroups based on demographic and clinical characteristics to determine the decoction's efficacy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with symptomatic heart failure and a left ventricular ejection fraction of less than 50%.

Not a fit: Patients with acute decompensated heart failure or those requiring major cardiovascular interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and clinical outcomes for heart failure patients.

How similar studies have performed: While this approach is novel in the context of heart failure treatment, similar studies evaluating traditional remedies have shown varying degrees of success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female, aged ≥18 years at the time of consent.
2. Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV).
3. LVEF \<50%.
4. NT-proBNP \>600 pg/ml or BNP ≥150 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml or BNP ≥100 pg/ml) at enrolment.
5. Provision of signed informed consent prior to any study specific procedures.

Exclusion Criteria:

1. Current acute decompensated HF or hospitalization due to decompensated HF, ACS, stroke or transient ischemic attack (TIA), coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\]) or valvular repair/replacement, or other major cardiovascular surgery within 4 weeks prior to enrolment.
2. Uncontrolled severe arrhythmia.
3. Planned to undergo heart transplantation or device implantation.
4. Hepatic impairment aspartate transaminase \[AST\] or alanine transaminase \[ALT\] \>3x the upper limit of normal \[ULN\]; or total bilirubin \>2x ULN at time of enrolment).
5. Severe infection.
6. eGFR \<30 mL/min/1.73 m\^2 by CKD-EPI.
7. Active malignancy requiring treatment at the time of visit 1.
8. Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding.
9. Any condition outside the CV and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 1 years based on investigator's clinical judgement.
10. Systolic blood pressure \< 90 mmHg, or systolic blood pressure ≥ 180 mmHg, or diastolic blood pressure ≥ 110 mmHg on 2 consecutive measurements.
11. Heart failure due to infiltrative cardiomyopathies(cardiac amyloidosis, etc.), fulminant myocarditis, constrictive pericarditis.
12. Participation in another clinical study.
13. Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.

Where this trial is running

Beijing, Beijing Municipality and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Heart Failure, ShengXian-QuYu Decoction, Heart failure with reduced ejection fraction, Heart failure with mildly reduced ejection fraction, Quality of life

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.