Ischemic Heart Failure
Conditions
Keywords
Ischemic Heart Failure, coronary artery disease, qi deficiency and blood stasis
Brief summary
The main purpose of this research is to reveal the curative effect mechanism of Yiqihuoxue prescription which treat the disease of qi deficiency and blood stasis. And at the same time this study also try to confirm yiqi huoxue fang qi deficiency blood stasis treatment of coronary heart disease (CHD) heart failure the curative effect and security.
Detailed description
Modern research has shown that the main mechanism of the qi deficiency and blood stasis of coronary disease combined with cardiac failure is the disorder Nerve-endocrine-immune network mechanism, disorder of energy metabolism, blood coagulation/anticoagulation imbalances, vascular endothelial injury and the expression of inflammatory factors and cytokines disorder, etc. Some studies have identified that the Chinese traditional medicine of supplementing qi and activating blood circulation drugs could adjust the nerve - endocrine - immune network, improve endothelial function, improve ventricular remodeling, ameliorate heart function, alleviate the clinical symptoms, enhance the quality of life, and so on. This study by comparing the curative effect of Yi-Qi Formula, Huoxue prescription and two prescription of yiqi huoxue (buyang huanwu decoction and Qishen Yiqi Drop Pill) on improving energy metabolism, ameliorating heart function, adjusting the blood coagulation and the expression of cell adhesion factor, improving endothelial function, to reveal the curative effect mechanism of Yiqihuoxue prescription which treat the disease of qi deficiency and blood stasis, and confirm the TCM theory that Qi and blood are correlated.
Interventions
DRUGYiqi prescription
DRUGHuoxue prescription
DRUGPlacebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
DRUGPlacebo 2
Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.
Sponsors
Zhu Mingjun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 40 to 75; 2. Patients with ischemic heart failure： LVEF less than or equal to 45% measured by echocardiography in modified Simpson method 3. Qi deficiency and blood stasis syndrome; 4. New York Heart Association (NYHA) Class II to Ⅲ ; 5. Submitted informed consent
Exclusion criteria
1. Combin the pulmonary embolism, or acute coronary syndrome (acs) ,or acute cerebrovascular disease; 2. Combin other heart diseases: valvular heart disease, dilated cardiomyopathy, hypertension heart disease, pulmonary heart disease,congenital heart disease; 3. Hypertension and diabetes patients treated with drugs but not controlled within standard limit; 4. Severe hepatic and renal dysfunction, malnutrition, malignant tumour; 5. Active tuberculosis or rheumatoid diseases; 6. Nosohemia, organ transplantation,uremia; 7. Psychosis and drug abuse; 8. Allergic to the drugs or one component medicine of the drugs of this study ; 9. Participated in other trials within 1 month ; 10. Being pregnant, planning for pregnancy or breastfeeding;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| N-terminal pronatriuretic peptide（NT-proBNP） | 0 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6MWT distance | 0,3rd,9th month | baseline, 3 months after treatment and follow-up 6 months |
| Minnesota heart failure quality of life scale | 0,3rd,9th month | baseline, 3 months after treatment and follow-up 6 months |
| sST2，Galectin3,PT,APTT,FBg,TT,TnT,CK,GLUT-1.GLUT-4,H-FABP | 0，3rd month | the expression of these may be related to Qi |
| TXA2,PGI2,CD31,CD18,CD11b,R,K,MA | 0，3rd month | the expression of these may be related to Xue |
| hs-CRP,IL-1β,IL-6,TNF-α,ICAM-1,VCAM-1,MCP-1,NO,ET-1 | 0，3rd month | the expression of these may be related to Mai |
| Echocardiography | 0,3rd,9th month | baseline, 3 months after treatment and follow-up 6 months |
| Cardiac magnetic resonance | 0，3rd month | baseline, 3 months after treatment |
| ultrasonic cardiogram | 0,3rd,9th month | baseline, 3 months after treatment and follow-up 6 months |
| Endothelial function | 0，3rd month | baseline, and after 3 months treatment |
| Cardiac function classification, NYHA | 0,1st,Sec,3rd,6th,9th,month | baseline, 3 months after treatment and follow-up 6 months |
| Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) | 0,3rd,9th month | baseline, 3 months after treatment and follow-up 6 months |
| blood and urine routine tests,liver and renal function tests,serum | 0,3rd,month | safety evaluation |
| electrolytes,electrocardiogram (ECG) | 0,3rd,month | safety evaluation |
| Composite endpoint | 1st,3rd,6th,9th, month | all-cause death, frequency of emergency/re-admission to hospital due to HF, frequency of re-admission due to cardiovascular disease, acute coronary syndrome, severe arrhythmia, cardiac shock, revascularization, stroke, pulmonary embolism and peripheral vascular incidences, etc. |
| Vascular ultrasound | 0，3rd month | baseline, and after 3 months treatment |
Countries
China
Contacts
Primary ContactWang Y xia
Backup ContactLi Bin
Outcome results
None listed