Dataset from A Multicenter Study to Evaluate Safety and Tolerability in Patients With Chronic Heart Failure and Reduced Ejection Fraction From PARADIGM-HF Receiving Open Label LCZ696

The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.

本研究旨在收集接受开放标签试验药物LCZ696的符合入组标准的PARADIGM-HF受试者的安全性与耐受性数据。作为本研究母体的PARADIGM-HF（NCT01035255）临床试验，于2014年3月完成预设的最终中期分析后，因LCZ696在射血分数降低型心力衰竭（heart failure with reduced ejection fraction, HFrEF）患者中展现出显著疗效而提前终止。