Clinical and Metabonomics Study on the Treatment of Heart Failure After Myocardial Infarction With Modified Wenxin Decoction

Heart Failure Clinical Trial

Official title:

Clinical and Metabonomics Study on the Treatment of Heart Failure After Myocardial Infarction With Modified Wenxin Decoction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04667598
• Other study ID #: JWWX-2020
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 15, 2020
• Est. completion date: June 30, 2023

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

To elucidate the efficacy and safety of weixin decoction in the treatment of heart failure after myocardial infarction.

Description:

To elucidate the long-term protective effect of flavored Wenxin Decoction on heart failure after myocardial infarction. To elucidate the effective components in the treatment of heart failure and the mechanism of metabolism regulation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 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 ? - ? level;
• LVEF 50% 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 of >;
• 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:
• Modified Wenxin Decoction
Mainly including make aconite , astragalus , Cassia twig , dried ginger , red peony root , Chuanxiong , Codonopsis codonopsis , Ophiopogon ophiopogon , Schisandra , Stamen , Asarum , licorice.

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	Rates of cardiac death, acute myocardial infarction, stroke, and heart failure readmission	One months after drug intervention
Secondary	Secondary indicators	NT-proBNP, six-minute walking experiment and echocardiographic	Into the group day 1, week 4, week 8, week 12