Back to resultsStudy on the Clinical and Mechanism of Wenyang Huoxue Decoction in Treating Heart Failure After Myocardial Infarction
Primary Purpose
Heart Failure, Myocardial Infarction
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Wenyang Huoxue Decoction
Wenyang Huoxue placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Wenyang Huoxue decoction
Eligibility Criteria
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.
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 Wenyang Huoxue Decoction, 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
The number of major cardiovascular events，These include death, myocardial infarction, and rehospitalization
Secondary Outcome Measures
Main observation indicators
The numerical of NT-proBNP
Secondary observation index
The Left ventricular ejection fractione of chocardiography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04695990
Brief Title
Study on the Clinical and Mechanism of Wenyang Huoxue Decoction in Treating Heart Failure After Myocardial Infarction
Official Title
Study on the Clinical and Mechanism of Wenyang Huoxue Decoction in Treating Heart Failure After Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (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
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Myocardial Infarction
Keywords
Wenyang Huoxue decoction
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 Wenyang Huoxue Decoction, 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)
Wenyang Huoxue Decoction
Other Intervention Name(s)
WYHX
Intervention Description
Wenyang Huoxue granules
Intervention Type
Drug
Intervention Name(s)
Wenyang Huoxue placebo
Other Intervention Name(s)
WYHX placebo
Intervention Description
Wenyang Huoxue placebo have an identical appearance and scent as the active treatment granules.
Primary Outcome Measure Information:
Title
Major cardiovascular events
Description
The number of major cardiovascular events，These include death, myocardial infarction, and rehospitalization
Time Frame
One months to 1 year after drug intervention
Secondary Outcome Measure Information:
Title
Main observation indicators
Description
The numerical of NT-proBNP
Time Frame
Into the group day 1, week 4, week 8, week 12
Title
Secondary observation index
Description
The Left ventricular ejection fractione of chocardiography
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 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.
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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Study on the Clinical and Mechanism of Wenyang Huoxue Decoction in Treating Heart Failure After Myocardial Infarction
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