Withdrawal of Beta- Blockers and ACE Inhibitors after Left Ventricular Systolic Function Recovery in Patient with Dilated Cardiomyopathy Randomized Control Trial

Introduction Recovery of left ventricle (LV) systolic function with normalization of ejection fraction (LVEF) occurs in 10 - 27% of patients with 80% maintaining recovery. However, the need for medical therapy after recovery is often questioned. Previous randomized studies of treatment withdrawal were small, not selected for non-ischemic dilated cardiomyopathy (DCM) and had a reference of improved or recovered LVEF to > 40% or > 10% change from LVEF at time of diagnosis. Hypothesis In patients with DCM with recovery of the LV systolic function to an EF (>50%), medical therapy withdrawal is possible without rebound LV systolic dysfunction. Method: This was a pilot randomized control open-label trial with 2:1 randomization for withdrawal of b-blockers and ACE inhibitors in patients with recovered LV systolic function. Patients’ medication discontinuation occurred in 2 phases with a six-month interval and patients were followed for one year. In phase 1, the b-blockers were withdrawn. In phase II, the ACE inhibitors were withdrawn. The primary endpoint was LVEF reduction ( Results There were 22 patients (10 females) enrolled. The mean age was 60 ± 12y. The mean LVEF at enrollment was 58 ± 5% with no significant difference in the mean LVEF in both groups. Sixteen patients were assigned to the withdrawalgroup and 6 assigned to the control group.The primary endpoint occurred in 44% of the withdrawal group compared to none of the control. Event free survival at 6 month and 1 year were 87.5% and 73% respectively, p-value 0.087. The mean LVEF at 1 year for the treatment withdrawal group was 46.8 ± 12% and control 55 ± 6%. The mean LVEF reduction was 10.6 ± 11%. The difference in the mean LVEF between the groups at 1 year was 8% with 95% CI (-3.3,20) at p-value 0.1. The difference in the mean LVEF at enrollment and at 1 year follow up for the medication withdrawal group was 10.6 ± 11% and 95% CI (4.6,16.49) with p-value 0.0017. Conclusions In DCM patients with recovery of LV systolic function, worsening of LVEF occurred after withdrawal of b-blockers and ACE inhibitors.