Clinical trial NCT02875639: A Clinical Research of Qi Deficiency and Blood Stasis Syndrome (Different Disease With Syndrome)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ischemic Heart Failure
Keywords: Ischemic Heart Failure
coronary artery disease
qi deficiency and blood stasis
Lead sponsor: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 180
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: N-terminal pronatriuretic peptide（NT-proBNP）
timeFrame: 0 month
measure: N-terminal pronatriuretic peptide（NT-proBNP）
timeFrame: 3rd month
measure: N-terminal pronatriuretic peptide（NT-proBNP）
timeFrame: 9th month
Secondary outcomes:
measure: Minnesota heart failure quality of life scale
timeFrame: 0,3rd,9th month
measure: sST2，Galectin3,PT,APTT,FBg,TT,TnT,CK,GLUT-1.GLUT-4,H-FABP
timeFrame: 0，3rd month
measure: TXA2,PGI2,CD31,CD18,CD11b,R,K,MA
timeFrame: 0，3rd month
measure: hs-CRP,IL-1β,IL-6,TNF-α,ICAM-1,VCAM-1,MCP-1,NO,ET-1
timeFrame: 0，3rd month
measure: Echocardiography
timeFrame: 0,3rd,9th month
measure: Cardiac magnetic resonance
timeFrame: 0，3rd month
measure: Vascular ultrasound
timeFrame: 0，3rd month
measure: Endothelial function
timeFrame: 0，3rd month
measure: Cardiac function classification, NYHA
timeFrame: 0,1st,Sec,3rd,6th,9th,month
measure: ultrasonic cardiogram
timeFrame: 0,3rd,9th month
measure: 6MWT distance
timeFrame: 0,3rd,9th month
measure: Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
timeFrame: 0,3rd,9th month
measure: blood and urine routine tests,liver and renal function tests,serum
timeFrame: 0,3rd,month
measure: electrolytes,electrocardiogram (ECG)
timeFrame: 0,3rd,month
measure: Composite endpoint
timeFrame: 1st,3rd,6th,9th, month
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: First affiliated hospital, Henan University of Traditional Chinese medicine
state: Henan
Study officials:
affiliation: First affiliated hospital, Henan University of Traditional Chinese medicine
name: Zhu M jun
role: STUDY_DIRECTOR
affiliation: First affiliated hospital, Henan University of Traditional Chinese medicine
name: Wang Y xia
role: PRINCIPAL_INVESTIGATOR
affiliation: First affiliated hospital, Henan University of Traditional Chinese medicine
name: Li Bin
role: PRINCIPAL_INVESTIGATOR
References:
citation: WRITING COMMITTEE MEMBERS; Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):e240-327. doi: 10.1161/CIR.0b013e31829e8776. Epub 2013 Jun 5. No abstract available.