Back to resultsClinical and Metabonomics Study on the Treatment of Heart Failure After Myocardial Infarction With Modified Wenxin Decoction
Primary Purpose
Heart Failure, Myocardial Infarction
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Modified Wenxin Decoction
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Traditional Chinese Medicine
Eligibility Criteria
Inclusion Criteria:
- 18-75 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.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Major cardiovascular events
Rates of cardiac death, acute myocardial infarction, stroke, and heart failure readmission
Secondary Outcome Measures
Secondary indicators
NT-proBNP， six-minute walking experiment and echocardiographic
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04667598
Brief Title
Clinical and Metabonomics Study on the Treatment of Heart Failure After Myocardial Infarction With Modified Wenxin Decoction
Official Title
Clinical and Metabonomics Study on the Treatment of Heart Failure After Myocardial Infarction With Modified Wenxin Decoction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2020 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jun Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To elucidate the efficacy and safety of weixin decoction in the treatment of heart failure after myocardial infarction.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Myocardial Infarction
Keywords
Traditional Chinese Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Modified Wenxin Decoction
Other Intervention Name(s)
placebo
Intervention Description
Mainly including make aconite , astragalus ， Cassia twig , dried ginger , red peony root , Chuanxiong , Codonopsis codonopsis , Ophiopogon ophiopogon , Schisandra , Stamen , Asarum , licorice.
Primary Outcome Measure Information:
Title
Major cardiovascular events
Description
Rates of cardiac death, acute myocardial infarction, stroke, and heart failure readmission
Time Frame
One months after drug intervention
Secondary Outcome Measure Information:
Title
Secondary indicators
Description
NT-proBNP， six-minute walking experiment and echocardiographic
Time Frame
Into the group day 1, week 4, week 8, week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-75 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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Li, MD
Phone
13051458913
Email
gamyylj@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Li, MD
Organizational Affiliation
Guang 'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29386200
Citation
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. Erratum In: Circulation. 2018 Mar 20;137(12 ):e493.
Results Reference
result
PubMed Identifier
17090774
Citation
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.
Results Reference
result
PubMed Identifier
9462531
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. doi: 10.1161/01.cir.97.3.282. No abstract available.
Results Reference
result
PubMed Identifier
21709062
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.
Results Reference
result
PubMed Identifier
19118718
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.jacc.2008.08.067.
Results Reference
result
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Clinical and Metabonomics Study on the Treatment of Heart Failure After Myocardial Infarction With Modified Wenxin Decoction
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