Study on the Clinical and Mechanism of Wenyang Huoxue Decoction in Treating Heart Failure After Myocardial Infarction

Heart Failure Clinical Trial

Official title:

Study on the Clinical and Mechanism of Wenyang Huoxue Decoction in Treating Heart Failure After Myocardial Infarction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04695990
• Other study ID #: wyhx-2020
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 15, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2020
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jun Li, MD
• Phone: 13051458913
• Email: gamyylj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in a Chinese population with heart failure after myocardial infarction. The objective is to observe the efficacy and safety of Wenyang huoxue fang in the treatment of heart failure after myocardial infarction.

Description:

Currently, there is a lack of high-quality evidence-based support for TCM treatment of heart failure after myocardial infarction. In addition, previous studies have found that the method of warming Yang and activating blood circulation is effective in treating coronary heart disease, and the core pathogenesis of heart failure after myocardial infarction is also Yang deficiency and blood stasis. Therefore, this project aims to evaluate the clinical value of warming Yang and activating blood circulation in the treatment of heart failure after myocardial infarction. Through pharmacological research and detection, the efficacy of Wenyang huoxue prescription in heart failure rats after intervention of myocardial infarction was evaluated, mir-233-ISO signaling pathway was detected before and after treatment, and its mechanism of action was further clarified from the perspective of epigenetics and classical pathway of heart failure. Objective To investigate the efficacy and safety of Wenyang Huoxue fang in the treatment of heart failure after myocardial infarction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18-75 years old;
• A history of acute myocardial infarction;
• Cardiac function grade II-IV;
• LVEF 40% or less; NT-proBNP level = 450 pg/mL; -All men and women can sign the informed consent form.-

Exclusion Criteria:

• Coronary artery bypass grafting was performed within 12 weeks.
• Undergo or possibly undergo cardiac resynchronization therapy;
• Primary valvular disease, left ventricular outflow tract obstruction, myocarditis, aneurysm, uncontrolled severe arrhythmia, cardiogenic shock, unstable angina pectoris, or acute myocardial infarction;
• Having a serious primary liver, kidney or blood system disease or having a serious mental illness or a systemic disease that is out of control;
• Serum creatinine > 194.5 mol/L or serum potassium > 5.5mmol /L;
• The level of alanine aminotransferase or alkaline phosphatase is 1.5 times of the normal upper limit ;
• Abnormal blood pressure control, systolic blood pressure exceeding 180mmHg or diastolic blood pressure exceeding 110mmHg;
• Pregnancy or lactation;
• Known or suspected allergy to research drugs;
• To receive another investigational drug within 30 days of randomization or to be unwilling or unable to provide written consent.

Related Conditions & MeSH terms

• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Wenyang Huoxue Decoction
Wenyang Huoxue granules
• Wenyang Huoxue placebo
Wenyang Huoxue placebo have an identical appearance and scent as the active treatment granules.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jun Li

References & Publications (5)

Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Lon — View Citation

Ezekowitz JA, Kaul P, Bakal JA, Armstrong PW, Welsh RC, McAlister FA. Declining in-hospital mortality and increasing heart failure incidence in elderly patients with first myocardial infarction. J Am Coll Cardiol. 2009 Jan 6;53(1):13-20. doi: 10.1016/j.ja — View Citation

Gerber Y, Melton LJ 3rd, Weston SA, Roger VL. Association between myocardial infarction and fractures: an emerging phenomenon. Circulation. 2011 Jul 19;124(3):297-303. doi: 10.1161/CIRCULATIONAHA.110.007195. Epub 2011 Jun 27. — View Citation

Gheorghiade M, Bonow RO. Chronic heart failure in the United States: a manifestation of coronary artery disease. Circulation. 1998 Jan 27;97(3):282-9. Review. — View Citation

Hildebrandt P. Systolic and nonsystolic heart failure: equally serious threats. JAMA. 2006 Nov 8;296(18):2259-60. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major cardiovascular events	The number of major cardiovascular events,These include death, myocardial infarction, and rehospitalization	One months to 1 year after drug intervention
Secondary	Main observation indicators	The numerical of NT-proBNP	Into the group day 1, week 4, week 8, week 12
Secondary	Secondary observation index	The Left ventricular ejection fractione of chocardiography	Into the group day 1, week 4, week 8, week 12