Heart failure with preserved ejection fraction combined with stable coronary artery disease
Conditions
Interventions
treatment group:Conventional anti-heart failure therapy + YiQi Fumai lyophilized powder for injection
control group:Conventional anti-heart failure therapy + placebo
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) patients who met the diagnosis of heart failure with preserved ejection fraction combined with stable coronary artery disease and whose cardiac function belonged to NYHA class II-III; (2) patients who met the diagnostic criteria of qi and yin deficiency syndrome in traditional Chinese medicine; (3) patients aged 40-75 years with no gender restriction; and (4) volunteers to be subjected to the test and signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Previous LVEF 3 times normal, alkaline phosphatase or bilirubin > 2 timesnormal); those with known severe renal impairment (eGFR 10 mol/L in the presence of standardised medication, or even diabetic ketoacidosis or hyperosmolar hyperglycaemic state.(7) Patients with combined psychosis, severe neurosis, malignant tumour; (8) Those who have participated in clinical trials of other drugs in the past month, or those who have used qi nourishing and yin nourishing herbal preparations; (9) Pregnant or lactating women; (10) Allergic constitution or those who are allergic to the known components of the test drug.(11) Those who meet the absolute contraindications to the 6-minute walk test: the presence of acute myocardial infarction within 7-10 d, coronary angioplasty <24 h high-risk unstable angina acute endocarditis, acute myocarditis or pericarditis, uncontrolled symptomatic or haemodynamic disturbances of cardiac arrhythmia, acute deep venous thrombosis, pulmonary embolism, symptomatic severe aortic stenosis or suspected aneurysm entrapment, notUncontrolled symptomatic heart failure, uncontrolled bronchial asthma attack, pulmonary oedema, acute respiratory failure with SpO2 <85% at rest and under oxygenation, syncope, acute infectious disease, or other condition that may have a relevant effect on the performance of the test (e.g. severe anaemia, acute liver or renal failure hypothyroidism or hyperthyroidism, etc.) Mental illness or cognitive impairment that renders it impossible to perform the procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Six-minute walk test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Kansas City Cardiomyopathy Questionnaire;cardiac ultrasound;Electrocardiogram;Readmission for heart failure;Soluble suppression of tumorigenicity 2 protein;Urinalysis;Cancer antigen 125;N-terminal pro-B-type natriuretic peptide;Blood routine;New York Heart Association classification;Cardiac death;Liver and kidney function;Traditional Chinese Medicine clinical syndrome score;cardiopulmonary motor functio; | — |
Countries
china
Contacts
Public ContactZhang Dawu
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed