Heart Failure With Reduced Ejection Fraction Clinical Trial
Official title:
Effects of "ShengXian-QuYu Decoction" on Quality of Life, Symptoms, and Biomarkers in Heart Failure Patients With Reduced Ejection Fraction: a Nationwide, Multicenter, Parallel Group, Randomized, Double-Blind, Placebo-Controlled Trial
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.
This is a nationwide, multicenter, parallel group, randomized, double-blind, placebo-controlled study in patients with 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. 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. ;
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