INTERVENTIONAL STUDY OF DILTIAZEM IN DILATED CARDIOMYOPATHY - A REPORT OF MULTIPLE CENTER CLINICAL-TRIAL IN CHINA - CHINESE COOPERATIVE GROUP OF DILTIAZEM INTERVENTION TRIAL IN DILATED CARDIOMYOPATHY

The aim of this study was to determine the interventional effects of d iltiazem on autoantibody mediated myocardial damage in dilated cardiom yopathy (DCM). 221 patients with DCM in 16 hospitals were included in the multiple centre clinical trial from January 1995 to November 1996, using the diltiazem or placebo based on the background therapy for he art failure. Patients were randomly divided into groups for a single b lind trial, followed by observation for an average of 7.4 months. Afte r treatment, the heart function of 84% of patients in the diltiazem gr oup recovered to grade I or II, but this occured for 64% of patients i n the placebo group. Heart-thorax ratio was decreased from 0.59+/-0.07 to 0.56+/-0.07 and the left ventricular end-diastolic dimension (LVED d) from 65.40+/-8.60 mm to 61.12+/-9.86 mm, the left ventricular eject ion fraction (EF) was increased from 35.75+/-10.78% to 42.52%+/-11.41% (P<0.01) in the diltiazem group (n=114). The above parameters were no t significantly changed in the placebo group (n=107). Mortality was 3. 5% in the diltiazem group and 11.2% in the placebo group (P<0.05). Fur ther analysis also shows that LVEDd were reduced and EF were obviously elevated in patients with DCM of LVEDd <70 mm but the above parameter s weren't improved in patients of LVEDd >70 mm. The study suggests tha t diltiazem is safe and effective in the treatment of DCM, the action mechanism might be intervention in antibody-mediated myocardial damage and protection of myocardium. Diltiazem is suitable for the treatment of the early stage in DCM. (C) 1998 Elsevier Science Ireland Ltd.