About: Sacubitril/Valsartan in Advanced Heart Failure with Reduced Ejection Fraction: Rationale/Design of the LIFE Trial

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About: Sacubitril/Valsartan in Advanced Heart Failure with Reduced Ejection Fraction: Rationale/Design of the LIFE Trial Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
title	Sacubitril/Valsartan in Advanced Heart Failure with Reduced Ejection Fraction: Rationale/Design of the LIFE Trial
Creator	Mann, Douglas Braunwald, Eugene Lala, Anuradha Ambrosy, Andrew Desvigne-Nickens, Patrice Devore, Adam Do, Claudius Gilotra, Nisha Givertz, Michael Gorodeski, Eiran Greene, Stephen Gupta, Divya Hernandez, Adrian Lewis, Gregory Mahr, Claudius Mcnulty, Steven Mohammed, Selma Redfield, Margaret Shah, Palak Starling, Randall Vader, Justin
source	Elsevier; Medline; PMC
abstract	Abstract The PARADIGM-HF trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in PARADIGM-HF had NYHA class IV symptomology; accordingly, data that informs the use of S/V among patients with advanced HF are limited. The LIFE (LCZ696 In Hospitalized Advanced Heart FailurE) study is a 24-week prospective, multicenter, double-blinded, double-dummy, active-comparator trial to assess the safety, efficacy and tolerability of S/V compared with V in patients with advanced HFrEF. The trial planned to randomize 400 patients age ≥18 years with advanced HF, defined as an EF ≤35%, NYHA functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/mL or N-terminal-pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/mL), and ≥1 objective finding(s) of advanced HF. Following a 3-7 day open-label run-in period with S/V 24/26 mg twice daily, patients are randomized 1:1 to S/V titrated to 97/103 mg twice daily versus 160 mg V twice daily. The primary endpoint is the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints include clinical outcomes, as well as safety and tolerability. Because of the COVID-19 pandemic enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis will consist of the first 335 randomized patients, whose clinical follow-up was not severely impacted by COVID-19.
has issue date	2020-06-10(xsd:dateTime)
bibo:doi	10.1016/j.jchf.2020.05.005
bibo:pmid	32641226
has license	els-covid
sha1sum (hex)	e9d8b303bada3c9d1187578269a34499aab2239a
schema:url	https://doi.org/10.1016/j.jchf.2020.05.005
resource representing a document's title	Sacubitril/Valsartan in Advanced Heart Failure with Reduced Ejection Fraction: Rationale/Design of the LIFE Trial
has PubMed Central identifier	PMC7286640
has PubMed identifier	32641226
schema:publication	JACC Heart Fail
resource representing a document's body	covid:e9d8b303bada3c9d1187578269a34499aab2239a#body_text
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