Dilated cardiomyopathy
Conditions
Interventions
control group:Placebo for Qishen Granule No. 3 Prescription
test group:Qishen Granules No. 3 Prescription
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for chronic heart failure; (2) Meet the diagnostic criteria for dilated heart disease; (3) Comply with the diagnostic criteria for heart failure toxic syndrome of dilated heart disease; (4) LVEF=40% and NT-proBNP=450pg/ml; (5) NYHA Class II-III; (6) Age 18-75; (7) Volunteer to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Acute stage of myocardial infarction; (2) Complicated with severe liver dysfunction (ALT>100U/L or AST>100U/L) severe renal dysfunction (glomerular filtration rate 5.5 mmol/L); (3) Severe blood disease or malignant tumor; (4) Pregnancy or lactation; (5) Mental illness patients; (6) Patients with severe heart failure and a life expectancy of less than half a year; (7) Those who have taken traditional Chinese medicine or proprietary Chinese medicine with similar functions or components to the trial medication within the past month; (8) Those who have known adverse reactions or allergies to the study drug; (9) Those who participated in clinical investigators of other drugs within 1 month before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of treatment (defined as effective after treatment when NT-proBNP decreases by more than 30%);Six-minute walking experiment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of major adverse cardiovascular events from baseline to 12 months of treatment;interventricular septal thickness;left ventricular end-systolic diameter;NYHA functional class;left ventricular end-diastolic dimension;Mitral valve early diastolic blood flow velocity/Tissue Doppler annulus early diastolic motion velocity;Minnesota Heart Failure Quality of Life Score;left ventricular fractional shortening;left ventricular ejection fraction;Kansas City Cardiomyopathy Quality of Life Scale;Peak mitral blood flow in early diastolic period/peak mitral blood flow in late diastolic period;left ventricular posterior wall thickness; | — |
Countries
China
Contacts
Public ContactRONG LI
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed