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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
shuai Mao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Left Ventricular Remodeling

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 1, 2016
    Last Updated
    February 4, 2016
    Sponsor
    shuai Mao
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    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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