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

NCT04667598 | Unknown Phase 2 DMC

• 1 other identifier: JWWX-2020
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Heart Failure; Myocardial Infarction

Keywords

Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Major cardiovascular events

  Rates of cardiac death, acute myocardial infarction, stroke, and heart failure readmission

  One months after drug intervention

Secondary Outcomes (1)

• Secondary indicators

  Into the group day 1, week 4, week 8, week 12

Study Arms (2)

Experimental group

EXPERIMENTAL

On the basis of basic western medicine treatment (secondary prevention of coronary heart disease + anti-heart failure treatment), Patients in this group will be given modified Wenxin Tang granules, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks.

Drug: Modified Wenxin Decoction

Control group

PLACEBO COMPARATOR

On the basis of basic western medicine treatment (secondary prevention of coronary heart disease + anti-heart failure treatment), Patients in this group will be given placebo, one dose per day, administered in two doses, 150-200 mL each time, for 12 weeks.

Drug: Modified Wenxin Decoction

Interventions

Modified Wenxin Decoction DRUG

Mainly including make aconite , astragalus ， Cassia twig , dried ginger , red peony root , Chuanxiong , Codonopsis codonopsis , Ophiopogon ophiopogon , Schisandra , Stamen , Asarum , licorice.

Also known as: placebo

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old；
• A history of acute myocardial infarction；
• Cardiac function Ⅱ - Ⅲ level；
• LVEF 50% or less;
• Nt-probnp level ≥ 450 pg/ mL；
• All men and women can sign the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jun Li: lead

Related 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, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.

  PMID: 29386200 RESULT

• Hildebrandt P. Systolic and nonsystolic heart failure: equally serious threats. JAMA. 2006 Nov 8;296(18):2259-60. doi: 10.1001/jama.296.18.2259. No abstract available.

  PMID: 17090774 RESULT

• 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. doi: 10.1161/01.cir.97.3.282. No abstract available.

  PMID: 9462531 RESULT

• 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.

  PMID: 21709062 RESULT

• 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.jacc.2008.08.067.

  PMID: 19118718 RESULT

MeSH Terms

Conditions

Heart Failure; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Jun Li, MD

  Guang 'anmen Hospital of China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Jun Li, MD

CONTACT

13051458913; gamyylj@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Li Jun

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 14, 2020
• Study Start: December 15, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: December 14, 2020

Record last verified: 2020-12