INOVATE-HF study closure
Dec. 8, 2015
The independent Data Safety Monitoring Board for the INOVATE-HF trial has completed a pre-specified interim analysis of the data and recommended the discontinuation of the INOVATE-HF trial due to statistical futility in the primary efficacy endpoint. The Steering Committee concurs with this decision.
Despite not meeting the primary efficacy endpoint for the overall enrolled cohort (reduction in heart failure hospitalization and all-cause mortality), many additional analyses on subgroups and secondary endpoints are in progress.
We are working with the FDA to determine potential options for a subsequent study, including an ability to leverage data from the INOVATE-HF study.
We wish to convey our deepest appreciation for over 5.5 years of effort from the 86 excellent sites in 9 countries and 730 patients with heart failure worldwide who contributed to the INOVATE-HF study. Although the primary endpoint was not reached, valuable information that will help create better treatments for people with heart failure was collected. We hope this will eventually lead to new therapies that will help patients with heart failure.