Susan Stienen1, Khibar Salah1, Andreas H M Moons2, Adrianus L M Bakx3, Petra E van Pol4, Jutta M Schroeder-Tanka5, Albertus J Voogel6, Jan T Keijer7, R A Mikael Kortz8, Cathelijne Dickhoff1, Paola G Meregalli1, Jan G Tijssen1, Yigal M Pinto1, Wouter E Kok9. 1. Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands. 2. Department of Cardiology, Slotervaartziekenhuis, Amsterdam, The Netherlands. 3. Department of Cardiology, BovenIJ Ziekenhuis, Amsterdam, The Netherlands. 4. Department of Cardiology, Rijnland Ziekenhuis, Leiderdorp, The Netherlands. 5. Department of Cardiology, Sint Lucas Andreas Ziekenhuis, Amsterdam, The Netherlands. 6. Department of Cardiology, Spaarne Ziekenhuis, Hoofddorp, The Netherlands. 7. Department of Cardiology, Tergooiziekenhuizen, Blaricum, The Netherlands. 8. Department of Cardiology, Flevoziekenhuis, Almere, The Netherlands. 9. Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands. Electronic address: w.e.kok@amc.uva.nl.
Abstract
BACKGROUND: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. STUDY DESIGN: 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-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. CONCLUSION: The PRIMA II trial aims at providing scientific evidence for the use of NT-proBNP-guided therapy compared with conventional treatment in patients admitted for ADHF.
RCT Entities:
BACKGROUND: 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. STUDY DESIGN: 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-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. CONCLUSION: The PRIMA II trial aims at providing scientific evidence for the use of NT-proBNP-guided therapy compared with conventional treatment in patients admitted for ADHF.
Authors: Julie McLellan; Carl J Heneghan; Rafael Perera; Alison M Clements; Paul P Glasziou; Karen E Kearley; Nicola Pidduck; Nia W Roberts; Sally Tyndel; F Lucy Wright; Clare Bankhead Journal: Cochrane Database Syst Rev Date: 2016-12-22
Authors: Frances M Russell; Robert R Ehrman; Robinson Ferre; Luna Gargani; Vicki Noble; Jordan Rupp; Sean P Collins; Benton Hunter; Kathleen A Lane; Phillip Levy; Xiaochun Li; Christopher O'Connor; Peter S Pang Journal: Heart Lung Date: 2018-11-15 Impact factor: 2.210
Authors: Khibar Salah; Susan Stienen; Andreas H M Moons; Adrianus L M Bakx; Petra E van Pol; R A Mikael Kortz; João Pedro Ferreira; Irene Marques; Jutta M Schroeder-Tanka; Jan T Keijer; Antoni Bayes-Genis; Yigal M Pinto; Jan G Tijssen; Wouter E Kok Journal: J Am Heart Assoc Date: 2019-07-12 Impact factor: 5.501
Authors: Khibar Salah; Susan Stienen; Yigal M Pinto; Luc W Eurlings; Marco Metra; Antoni Bayes-Genis; Valerio Verdiani; Jan G P Tijssen; Wouter E Kok Journal: Heart Date: 2019-04-08 Impact factor: 5.994