Rationale and design of PRIMA II: A multicenter, randomized clinical trial to study the impact of in-hospital guidance for acute decompensated heart failure treatment by a predefined NT-PRoBNP target on the reduction of readmIssion and Mortality rAtes

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• 作者：Susan Stienen ; MD^a ; Khibar Salah ; MD^a ; Andreas H.M. Moons ; MD ; PhD^b ; Adrianus L.M. Bakx ; MD^c ; Petra E. van Pol ; MD^d ; Jutta M. Schroeder-Tanka ; MD ; PhD^e ; Albertus J. Voogel ; MD ; PhD^f ; Jan T. Keijer ; MD ; PhD^g ; R.A. Mikael Kortz ; MD^h ; Cathelijne Dickhoff ; MD^a ; Paola G. Meregalli ; MD ; PhD^a ; Jan G. Tijssen ; MD ; PhD^a ; Yigal M. Pinto ; MD ; PhD^a ; Wouter E. Kok ; MD ; PhD^a ; ^{w.e.kok@amc.uva.nl" class="auth_mail}
• 刊名：American Heart Journal
• 出版年：July 2014
• 年：2014
• 卷：168
• 期：1
• 页码：30-36
• 全文大小：214 K

文摘

Hospital admissions for acute decompensated heart failure (ADHF) are frequent and are accompanied by high percentages of mortality and readmissions. Brain natriuretic peptide (BNP) and the inactive N-terminal fragment of its precursor proBNP (NT-proBNP) are currently the best predictors of prognosis in heart failure (HF) patients. In the setting of chronic HF, studies that performed guidance of therapy by NT-proBNP have had only limited success. For patients with ADHF, retrospective studies have shown that a reduction in NT-proBNP of ≤30% during admission is a significant predictor of HF readmissions and mortality. These data suggest a role for NT-proBNP guidance in the setting of ADHF admissions.

<h4 id="absSec_2">Study designh4>

The PRIMA II is an investigator-initiated, multicenter, randomized, controlled, prospective 2-arm trial that investigates the impact of inhospital guidance for ADHF treatment by a predefined NT-proBNP target (>30% reduction during admission) on the reduction of readmission and mortality rates within 180 days. Consenting ADHF patients with NT-proBNP levels of >1,700 ng/L are eligible. After achieving clinical stability, a total of 340 patients are randomized to either NT-proBNP&ndash;guided or conventional treatment (1:1). The primary end point is dual, that is, a composite of all-cause mortality and readmission for HF in 180 days and the number of days alive out of hospital in 180 days. Secondary end points are readmissions and/or mortality in 180 days, cost effectiveness of hospitalization days in 180 days, readmissions and mortality in 90 days, and quality of life.

<h4 id="absSec_3">Conclusionh4>

The PRIMA II trial aims at providing scientific evidence for the use of NT-proBNP&ndash;guided therapy compared with conventional treatment in patients admitted for ADHF.