title: 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.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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: Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
authors: Susan
authors: S
authors: Stienen
authors: Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
authors: Khibar
authors: K
authors: Salah
authors: Department of Cardiology, Slotervaartziekenhuis, Amsterdam, The Netherlands.
authors: Andreas H M
authors: AH
authors: Moons
authors: Department of Cardiology, BovenIJ Ziekenhuis, Amsterdam, The Netherlands.
authors: Adrianus L M
authors: AL
authors: Bakx
authors: Department of Cardiology, Rijnland Ziekenhuis, Leiderdorp, The Netherlands.
authors: Petra E
authors: PE
authors: van Pol
authors: Department of Cardiology, Sint Lucas Andreas Ziekenhuis, Amsterdam, The Netherlands.
authors: Jutta M
authors: JM
authors: Schroeder-Tanka
authors: Department of Cardiology, Spaarne Ziekenhuis, Hoofddorp, The Netherlands.
authors: Albertus J
authors: AJ
authors: Voogel
authors: Department of Cardiology, Tergooiziekenhuizen, Blaricum, The Netherlands.
authors: Jan T
authors: JT
authors: Keijer
authors: Department of Cardiology, Flevoziekenhuis, Almere, The Netherlands.
authors: R A Mikael
authors: RA
authors: Kortz
authors: Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
authors: Cathelijne
authors: C
authors: Dickhoff
authors: Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
authors: Paola G
authors: PG
authors: Meregalli
authors: Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
authors: Jan G
authors: JG
authors: Tijssen
authors: Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands.
authors: Yigal M
authors: YM
authors: Pinto
authors: Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands. Electronic address: w.e.kok@amc.uva.nl.
authors: Wouter E
authors: WE
authors: Kok
mesh_terms: D000208:Acute Disease; D000328:Adult; D015415:Biomarkers / Q000097:blood; D002423:Cause of Death / Q000639:trends; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000097:blood / Q000401:mortality / Q000628:therapy*; D017052:Hospital Mortality / Q000639:trends; D006801:Humans; D058990:Molecular Targeted Therapy / Q000379:methods*; D020097:Natriuretic Peptide, Brain / Q000097:blood*; D009426:Netherlands / Q000453:epidemiology; D010359:Patient Readmission / Q000639:trends*; D010446:Peptide Fragments / Q000097:blood*; D017410:Practice Guidelines as Topic / Q000592:standards*; D011379:Prognosis; D011446:Prospective Studies; D011788:Quality of Life; D015996:Survival Rate / Q000639:trends; D013997:Time Factors
chemical_list: D015415:Biomarkers; D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain