Danlou Tablets to Prevent Left Ventricular Remodeling

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: shuai Mao

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