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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
336
Specification: 30ml/bag, given twice daily, per oral use.
Placebo matching ShengXian-QuYu Decoction, 30ml/bag, given twice daily, per oral use.
Change From Baseline in the KCCQ Clinical Summary Score
KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Time frame: Up to 12 weeks
Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Traditional Chinese Medicine Syndrome Score is a instrument that quantifies symptoms. Lower TCM scores reflect better health status.
Time frame: Up to 12 weeks
Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance
Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. Change from baseline was defined as the distance walked in 6 minutes at week 12 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication.
Time frame: Up to 12 weeks
Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NT-proBNP). Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine
Beijing, Beijing Municipality, China
RECRUITINGDongcheng District First People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGDongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
RECRUITINGHuairou District Traditional Chinese Medicine Hospital of Beijing
Beijing, Beijing Municipality, China
RECRUITINGBeijing Changping Nankou Hospital
Beijing, Beijing Municipality, China
RECRUITINGChangping District Traditional Chinese Medicine Hospital
Beijing, Beijing Municipality, China
RECRUITINGTang County Hospital of Traditional Chinese Medicine
Baoding, Hebei, China
RECRUITINGFuning Hospital of Traditional Chinese Medicine
Qinhuangdao, Hebei, China
RECRUITING...and 16 more locations
Time frame: Up to 12 weeks
Change in Left Ventricular Systolic Function
Change in left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography.
Time frame: Up to 12 weeks
Change in Left Ventricular End-Diastolic Diameter
Change in left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography.
Time frame: Up to 12 weeks
Change in Left Ventricular End-Systolic Diameter
Change in left ventricular end-systolic diameter is assessed by two-dimensional directed M-mode echocardiography.
Time frame: Up to 12 weeks
Change in Estimated Glomerular Filtration Rate from Baseline
Estimated glomerular filtration rate (eGFR) is calculated by the CKD-EPI equation.
Time frame: Up to 12 weeks
Change From Baseline in the KCCQ Clinical Summary Score
KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Time frame: Up to 26 weeks
Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Traditional Chinese Medicine Syndrome Score is a instrument that quantifies symptoms. Lower TCM scores reflect better health status.
Time frame: Up to 26 weeks