Clinical and Metabonomics Study on the Treatment of Heart Failure After Myocardial Infarction With Modified Wenxin Decoction
NCT ID: NCT04667598
Last Updated: 2020-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2020-12-15
2023-06-30
Brief Summary
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Detailed Description
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To elucidate the effective components in the treatment of heart failure and the mechanism of metabolism regulation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
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.
Modified Wenxin Decoction
Mainly including make aconite , astragalus ， Cassia twig , dried ginger , red peony root , Chuanxiong , Codonopsis codonopsis , Ophiopogon ophiopogon , Schisandra , Stamen , Asarum , licorice.
Control group
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.
Modified Wenxin Decoction
Mainly including make aconite , astragalus ， Cassia twig , dried ginger , red peony root , Chuanxiong , Codonopsis codonopsis , Ophiopogon ophiopogon , Schisandra , Stamen , Asarum , licorice.
Interventions
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Modified Wenxin Decoction
Mainly including make aconite , astragalus ， Cassia twig , dried ginger , red peony root , Chuanxiong , Codonopsis codonopsis , Ophiopogon ophiopogon , Schisandra , Stamen , Asarum , licorice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Jun Li
OTHER
Responsible Party
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Jun Li
Li Jun
Principal Investigators
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Jun Li, MD
Role: STUDY_DIRECTOR
Guang 'anmen Hospital of China Academy of Chinese Medical Sciences
Central Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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JWWX-2020
Identifier Type: -
Identifier Source: org_study_id