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Trends of CRT therapy in heart failure patients with reduced ejection fraction on LCZ696 versus Enalapril
Proposal
5791
Title of Proposed Research
Trends of CRT therapy in heart failure patients with reduced ejection fraction on LCZ696 versus Enalapril
Lead Researcher
Abdullah Sarkar MD
Affiliation
University of Miami
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
19 June 2019
Lay Summary
Heart failure is a common illness among individuals in America and around the world. This has led to extensive research for optimal treatments for these patients. In addition to currently available therapies, Novartis has manufactured LCZ696 which was studied in clinical trials earlier. The drug LCZ696 utilizes a novel chemical that increases a chemical, natriuretic peptide, normally produced by the human body to counteract the adverse effects of heart failure. The clinical trial compared 8442 patients on Enalapril (standard of care medication) versus LCZ696. LZ696 significantly reduced the risk of death and of hospitalization for heart failure. CRT (cardiac resynchronization therapy) is a device that controls when and how the heart pumps. This device is indicated in certain patients with severe heart failure despite optimal treatment with medications. Given the evidence that LCZ696 is a more robust medication in comparison to standard of care medication in patients with heart failure, it is likely that the indication for CRT has decreased. We hope to study this topic to identify LCZ696's influence on the trend for CRT use in patients with severe heart failure.
Study Data Provided
[{ "PostingID": 4062, "Title": "NOVARTIS-CLCZ696B2314", "Description": "A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction" }]
Statistical Analysis Plan
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