Heart Failure Trial Shut Down After Primary Endpoint Met
Novartis announced the early closure of its Phase 3 PARADIGM-HF study, indicating that patients with chronic heart failure with reduced ejection fraction (HF-REF) who received LCZ696 lived longer without being hospitalized for heart failure than those who received standard care with ACE-inhibitor enalapril.
PARADIGM-HF is a randomized, double-blind, outcome study evaluating the efficacy and safety profile of LCZ696 vs. enalapril in 8,436 patients with HF-REF. The primary outcome was a composite of time to first occurrence of either cardiovascular death or heart failure hospitalization. The trial is also designed to be able to detect a significant difference in cardiovascular death. The study was initiated in December 2009 and currently is the largest clinical trial in heart failure ever undertaken.
The trial has now been closed based on the Data Monitoring Committee's (DMC) recommendations since the primary endpoint was met. This follows two previous interim analyses that showed the safety profile of LCZ696 was acceptable. Results will be presented at a major medical conference for presentation.
LCZ696 is the first in a new class of medicines called Angiotensin Receptor Neprilysin Inhibitor (ARNI) that acts in multiple ways on the neurohormonal systems of the heart. It blocks receptors exerting harmful effects while simultaneously promoting protective mechanisms. LCZ696 is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover.
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