Danlou Tablets to Prevent Left Ventricular Remodeling
Primary Purpose
Left Ventricular Remodeling, Acute Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Danlou Tablets
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Left Ventricular Remodeling
Eligibility Criteria
Inclusion Criteria:
- acute myocardial infarction
- successfully underwent revascularization
Exclusion Criteria:
- previous myocardial infarction within 30 days
- malignant arrhythmia
- congenital heart disease
- cardiac shock
- documented or suspected history of heart failure or depressed LV ejection fraction <15%
- planned coronary artery bypass grafting
- a life expectancy of <1 year
- hepatic impairment
- glomerular filtration rate ≤30 mL/min per 1.73 m2
- autoimmune or connective tissue disease
- chronic substance abuse or psychiatric illness
- unable to complete 3 month clinical follow-up
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Danlou Tablets
placebo
Arm Description
Danlou tablets (4.5 g oral dose taken once daily) for 90 days
matching placebo for 90 days
Outcomes
Primary Outcome Measures
change in the Left Ventricular End Diastolic Volume Index from baseline to 90 days
Left Ventricular End Diastolic Volume Index (LVEDVi) measured by two-dimensional echocardiography.
Secondary Outcome Measures
changes in Left ventricular End Systolic Volume Index from baseline to 90 days
Left Ventricular End Systolic Volume Index (LVESVi) measured by two-dimensional echocardiography.
Major adverse cardiovascular events
Major adverse cardiovascular events includes cardiac death, cardiac shock, myocardial infarction, documented unstable angina requiring revascularization (bypass surgery or repeat PCI), severe angina or severe heart failure.
adverse events
Left ventricular Ejection Fraction from baseline to 90 days
Left ventricular Ejection Fraction (LVEF) measured by two-dimensional echocardiography.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02675322
Brief Title
Danlou Tablets to Prevent Left Ventricular Remodeling
Official Title
Effects of Danlou Tablets to Prevent Left Ventricular Remodeling After Myocardial Infarction: A Double-blind, Randomized, Placebo Controlled, Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
shuai Mao
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Danlou tablets are Chinese patent medicine which has been approved in China for the treatment of ischemic heart disease, but the evidence supporting its efficacy on cardiac remodeling remains unclear. This pilot study was designed to determine whether Danlou tablets reduced adverse left ventricular (LV) remodeling in patients with acute myocardial infarction (MI). Patients following acute MI were enrolled and randomly allocated to Danlou tablets (4.5 g q.d. for 90 days) or placebo, superimposed on standard medications for the treatment of MI. Major end points were changes in LV volumes and ejection fractions as evaluated by serial echocardiography in addition to clinical outcomes were also determined.
Detailed Description
This randomized, prospective, double-blind, placebo-controlled, parallel-group clinical trial was performed in two institutions (Guangdong Provincial Hospital of CM and Wuyi Hospital of CM). The study was conducted in accordance with the Declaration of Helsinki and its text revisions and all participants provided written informed consent before enrollment. The Clinical Research Ethical Committee at Guangdong Provincial Hospital of Chinese Medicine approved the research protocol (B2011-41-01).
Once eligible candidates had undergone PCI, they were admitted to the coronary intensive care unit and received standard treatment according to the institutional protocol based on American College of Cardiology/ American Heart Association and European Society of Cardiology guidelines.20 Simultaneously, patients were randomized assigned in a 1:1 ratio to receive Danlou tablets (4.5 g oral dose taken once daily) or matching placebo for 90 days according to a computer-generated site-stratified, block randomization schedule. Danlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Remodeling, Acute Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Danlou Tablets
Arm Type
Experimental
Arm Description
Danlou tablets (4.5 g oral dose taken once daily) for 90 days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo for 90 days
Intervention Type
Drug
Intervention Name(s)
Danlou Tablets
Other Intervention Name(s)
Danlou
Intervention Description
Danlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo with no chemical effects.
Primary Outcome Measure Information:
Title
change in the Left Ventricular End Diastolic Volume Index from baseline to 90 days
Description
Left Ventricular End Diastolic Volume Index (LVEDVi) measured by two-dimensional echocardiography.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
changes in Left ventricular End Systolic Volume Index from baseline to 90 days
Description
Left Ventricular End Systolic Volume Index (LVESVi) measured by two-dimensional echocardiography.
Time Frame
90 days
Title
Major adverse cardiovascular events
Description
Major adverse cardiovascular events includes cardiac death, cardiac shock, myocardial infarction, documented unstable angina requiring revascularization (bypass surgery or repeat PCI), severe angina or severe heart failure.
Time Frame
90 days
Title
adverse events
Time Frame
180 days
Title
Left ventricular Ejection Fraction from baseline to 90 days
Description
Left ventricular Ejection Fraction (LVEF) measured by two-dimensional echocardiography.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute myocardial infarction
successfully underwent revascularization
Exclusion Criteria:
previous myocardial infarction within 30 days
malignant arrhythmia
congenital heart disease
cardiac shock
documented or suspected history of heart failure or depressed LV ejection fraction <15%
planned coronary artery bypass grafting
a life expectancy of <1 year
hepatic impairment
glomerular filtration rate ≤30 mL/min per 1.73 m2
autoimmune or connective tissue disease
chronic substance abuse or psychiatric illness
unable to complete 3 month clinical follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
minzhou zhang, M.D.
Organizational Affiliation
Heart Center
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27825334
Citation
Mao S, Wang L, Ouyang W, Zhou Y, Qi J, Guo L, Zhang M, Hinek A. Traditional Chinese medicine, Danlou tablets alleviate adverse left ventricular remodeling after myocardial infarction: results of a double-blind, randomized, placebo-controlled, pilot study. BMC Complement Altern Med. 2016 Nov 8;16(1):447. doi: 10.1186/s12906-016-1406-4.
Results Reference
derived
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Danlou Tablets to Prevent Left Ventricular Remodeling
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