HFpEF
Conditions
Interventions
Control group:Conventional treatment + Yiqi Huoxue formula simulator
Experimental group:Conventional treatment + Yiqi Huoxue formula
Sponsors
The First Affiliated Hospital of Henan University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria to be eligible for the study: (1) Age between 18 and 75 years with no gender restrictions; (2) Meeting the diagnostic criteria for coronary heart disease; (3) LVEF=50%detected by echocardiography; (4) BNP=35 pg/ml or NT-proBNP=125pg/ml (BNP=105pg/ml or NT-porBNP=365pg/ml in atrial fibrillation patients); (5) Meeting the TCM diagnostic criteria for qi deficiency and blood stasis syndrome; (6) Voluntarily signing the written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria must be excluded from the test: (1)Diagnosed with hypertrophic obstructive cardiomyopathy cardiac amyloidosis hemochromatosis Fabry disease stress-induced cardiomyopathy constrictive pericarditis muscular dystrophy severe valvular heart disease; (2)Subjects were diagnosed with stroke or transient ischemic attack undergone coronary artery bypass surgery valve replacement surgery or other major cardiovascular surgeries within the last 3 months; (3)Unable to exercise due to pulmonary diseases (first-second forced expiratory volume [FEV1] < 50% of predicted value COPD GOLD III-IV) or other conditions that may interfere with cardiopulmonary exercise function; (4)A variety of serious diseases affecting the clinical trial progresssuch as acute exacerbation of chronic obstructive pulmonary disease acute or chronic liver diseases (ALT=3 times the upper limit of normal) severe renal dysfunction (creatinine=3 mg/dL or eGFR=60 ml/min·1.73m2 or regular dialysis subjects) anemia (hemoglobin<90g/L) gastrointestinal surgeries or gastrointestinal diseases that may affect the absorption of the study drug acute or chronic pancreatitis serious primary diseases in the blood system and nervous system any recorded active or suspected malignant tumors or a history of malignant tumors within 1 year before screening; (5)Any disease other than heart failure that the investigator considers to be causing life expectancy < 6 months; (6)Pregnant currently breastfeeding or preparing for pregnancy; (7)Allergic constitution allergic to multiple drugs or foods or known to be allergic to the components of Yiqi Huoxue prescription; (8)Unable to exercise or the subject is determined by the researcher to be likely to affect exercise; Unable to take care of oneself or unable to take oral medications; (9)Use of Chinese medicine with similar curative effect (Chinese medicine decoctionChinese patent medicine Chinese medicine injectionetc.) in the past 7 days; (10)Undergoing any investigational treatment other than the study drug; (11) Suspected or confirmed history of alcohol or drug abuse; (12) Unable to follow the research assessment schedule for follow-up or not suitable for participation in the trial according to the investigator's clinical judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiopulmonary Exercise Test Peak Oxygen Uptake (Peak VO2); | — |
Secondary
| Measure | Time frame |
|---|---|
| Coagulation function;TCM symptom score;N-Terminal Pro-Brain Natriuretic Peptide(NT-proBNP);NYHA cardiac function classification;Cardiac ultrasound;Main symptoms/signs; | — |
Countries
China
Contacts
Public Contactzhumingjun
The First Affiliated Hospital of Henan University of Chinese Medicine
Outcome results
None listed