SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction

Official title

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

Overview

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 and mildly reduced ejection fraction.

Detailed description

This is a pragmatic, nationwide, multicenter, parallel group, randomized, double-blind, placebo-controlled study in patients with heart failure with reduced and mildly ejection fraction, evaluating the effect of "ShengXian-QuYu Decoction" versus placebo, given twice daily in addition to background regional standard of care. 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.

Interventions

• Drug ShengXian-QuYu Decoction
  Specification: 30ml/bag, given twice daily, per oral use.
• Other Placebo
  Placebo matching ShengXian-QuYu Decoction, 30ml/bag, given twice daily, per oral use.

Primary outcome measures

• Change From Baseline in the KCCQ Clinical Summary Score [Time frame: Up to 12 weeks]

Secondary outcome measures (9)

• Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) [Time frame: Up to 12 weeks]
• Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance [Time frame: Up to 12 weeks]
• Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) [Time frame: Up to 12 weeks]
• Change in Left Ventricular Systolic Function [Time frame: Up to 12 weeks]
• Change in Left Ventricular End-Diastolic Diameter [Time frame: Up to 12 weeks]
• Change in Left Ventricular End-Systolic Diameter [Time frame: Up to 12 weeks]
• Change in Estimated Glomerular Filtration Rate from Baseline [Time frame: Up to 12 weeks]
• Change From Baseline in the KCCQ Clinical Summary Score [Time frame: Up to 26 weeks]
• Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) [Time frame: Up to 26 weeks]

Eligibility criteria

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 <50%.
• 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.

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

Double blind

Primary purpose

Treatment

Study locations

China · 26 centers

• China-Japan Friendship Hospital — Beijing
• Peking University People's Hospital — Beijing
• Beijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine — Beijing
• Dongcheng District First People's Hospital — Beijing
• Dongfang Hospital Affiliated to Beijing University of Chinese Medicine — Beijing
• Huairou District Traditional Chinese Medicine Hospital of Beijing — Beijing
• Beijing Changping Nankou Hospital — Beijing
• Changping District Traditional Chinese Medicine Hospital — Beijing
• … and 18 more centers

Identifiers

NCT: NCT05583773 · 2022-NHLHCRF-LX-02-0102

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗