Shengxian Quyu Decoction in the Treatment of Heart Failure With Reduced Ejection Fraction

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    308
  • sponsor
    China-Japan Friendship Hospital
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Updated on 6 April 2023
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Summary

The purpose of this study is to conduct a multicenter, randomized clinical trial to evaluate the effect of "Shengxian Quyu Decoction" on quality of life , symptoms, and biomarkers in heart failure patients with reduced ejection fraction.

Description

This is a multicenter, prospective, randomised, placebo-controlled study in patients with chronic heart failure with reduced ejection fraction (HFrEF), evaluating the effect of "Shengxian Quyu Decoction" versus placebo, given twice daily in addition to background regional standard of care therapy. The effect of "Shengxian Quyu Decoction"on quality of life, symptoms and biomarkers will be evaluated.

The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography, heart failure characteristics, Traditional Chinese Medicine syndrome type, diabetes status, kidney function, left ventricular ejection fraction, natriuretic peptide, and additional co-morbidities, concomitant medications, and others.

Details
Condition Heart Failure With Reduced Ejection Fraction
Treatment Placebo, Shengxian Quyu Decoction
Clinical Study IdentifierNCT05583773
SponsorChina-Japan Friendship Hospital
Last Modified on6 April 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female, aged ≥18 years at the time of consent
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV)
LVEF<40%
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
Provision of signed informed consent prior to any study specific procedures

Exclusion Criteria

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
Uncontrolled severe arrhythmia
Planned to undergo heart transplantation or device implantation
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)
Severe infection
eGFR <30 mL/min/1.73 m^2 by CKD-EPI
Active malignancy requiring treatment at the time of visit 1
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
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
Systolic blood pressure < 90 mmHg, or systolic blood pressure ≥ 180 mmHg, or diastolic blood pressure ≥ 110 mmHg on 2 consecutive measurements
Heart failure due to infiltrative cardiomyopathies(cardiac amyloidosis, etc.), fulminant myocarditis, constrictive pericarditis
Participation in another clinical study
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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