Main objective: To evaluate the efficacy, safety and clinical dose exploration of Qishen Yiqi dripping pills in the treatment of chronic heart failure with preserved ejection fraction.
Main objective: To evaluate the efficacy, safety and clinical dose exploration of Qishen Yiqi dripping pills in the treatment of chronic heart failure with preserved ejection fraction. Exploratory research objective: To explore the changes of endogenous substances in vivo before and after drug administration, to interpret the mechanism of drug action through metabolomics and systems biology methods, and to find potential clinical biomarkers for exploratory subgroup analysis of clinical trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
225
Take 3 times a day after meals,24 weeks
Take 3 times a day after meals,24 weeks
Take 3 times a day after meals,24 weeks
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
6-Minutes-Walking-Test (6MWT)
Change from baseline to weeks 12 and 24 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.
Time frame: Baseline to weeks 12 and 24
NT-proBNP
Change from baseline to weeks 2,4,8,12,16,20 and 24 in NT-proBNP.
Time frame: Baseline to weeks 2,4,8,12,16,20 and 24
LAVI, E/ E ', E 'mean value, LVEF and tricuspid regurgitation velocity
Change from baseline to weeks 4,12 and 24 in left atrial volume index, mitral inflow velocity early diastolic blood flow velocity peak to mitral annular relaxation velocity ratio, mitral annular relaxation velocity mean value, left ventricular ejection fraction and tricuspid regurgitation velocity measured by echocardiography.
Time frame: Baseline to weeks 4,12 and 24
Hospitalizations for heart failure (first or repeated) and deaths from cardiovascular disease
Compound and separate rates of hospitalization for heart failure (first or repeated) and death from cardiovascular disease at week 24.
Time frame: Week 24
NYHA classification
Percentage of subjects whose NYHA classification improved/worsened/remained unchanged from baseline to weeks 2,4,8,12,16,20 and 24.
Time frame: Baseline to weeks 2,4,8,12,16,20 and 24
Minnesota Living With Heart Failure Questionnaire(MLHFQ) Score
Change from baseline to weeks 12 and 24 in Minnesota Living With Heart Failure Questionnaire(MLHFQ) Score.
Time frame: Baseline to weeks 12 and 24
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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Bejing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Hebei General Hospital
Shijiazhuang, Hebei, China
The Third Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
The third Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
...and 6 more locations