Clinical trial NCT02675322: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Left Ventricular Remodeling
Acute Myocardial Infarction
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: change in the Left Ventricular End Diastolic Volume Index from baseline to 90 days
timeFrame: 90 days
Secondary outcomes:
measure: changes in Left ventricular End Systolic Volume Index from baseline to 90 days
timeFrame: 90 days
measure: Major adverse cardiovascular events
timeFrame: 90 days
measure: adverse events
timeFrame: 180 days
measure: Left ventricular Ejection Fraction from baseline to 90 days
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Heart Center
name: minzhou zhang, M.D.
role: STUDY_CHAIR
References:
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.