title: Adding serial N-terminal pro brain natriuretic peptide measurements to optimal clinical management in outpatients with systolic heart failure: a multicentre randomized clinical trial (NorthStar monitoring study).
abstract: OBJECTIVE
  This study was designed to evaluate a new NT-proBNP monitoring concept in outpatients with systolic heart failure (HF).
  
  
  RESULTS
  This was a multicentre, prospective randomized open-label blinded endpoint study. A total of 407 systolic HF patients were allocated to either clinical management (n = 208) or clinical management + NT-proBNP monitoring (n = 199) and followed for 2.5 years. If NT-proBNP increased >30%, a clinical checklist was completed and treatment initiated. The patients were matched at randomization and were 73 years old, 25% were females, 85% were NYHA class I-II, LVEF was 30%, and NT-proBNP 1955 pg/mL. NT-proBNP monitoring did not improve outcome, the hazard ratio for the primary composite endpoint (death or a cardiovascular admission) being 0.96 [95% confidence interval (CI) 0.71-1.29, P = 0.766]. NT-proBNP monitoring did not induce a significant change in the pharmacological strategy (P > 0.05 for all comparisons). In patients in whom NT-proBNP increased >30% (25% of the patients) during follow-up, a higher frequency of admission (69% vs. 47%, P = 0.002), a higher number of admission days (14 vs. 5 days, P = 0.003) and number of admissions (2 vs. 1, P = 0.009), and a lower quality of life (P = 0.032) and a poorer functional class (37% vs. 18% in NYHA class III-IV, P < 0.001) were observed.
  
  
  CONCLUSIONS
  Adding serial measurements of NT-proBNP to optimal clinical management was not associated with a change in pharmacological strategy and did not improve outcome. However, survivors in whom NT-proBNP increased >30% showed a poorer functional class, clinical outcome, and quality of life.
  
  
  BACKGROUND
  www.centerwatch: 173491 (NorthStar).
authors.affiliation: Rigshospitalet, DK-2100 Copenhagen E, Denmark. m.schou@dadlnet.dk
authors.forename: Morten
authors.initials: M
authors.lastname: Schou
authors.forename: Finn
authors.initials: F
authors.lastname: Gustafsson
authors.forename: Lars
authors.initials: L
authors.lastname: Videbaek
authors.forename: Helge
authors.initials: H
authors.lastname: Andersen
authors.forename: Jens
authors.initials: J
authors.lastname: Toft
authors.forename: Ole
authors.initials: O
authors.lastname: Nyvad
authors.forename: Henrik
authors.initials: H
authors.lastname: Ryde
authors.forename: Lars
authors.initials: L
authors.lastname: Fog
authors.forename: Jens C H
authors.initials: JC
authors.lastname: Jensen
authors.forename: Olav W
authors.initials: OW
authors.lastname: Nielsen
authors.forename: Soren
authors.initials: S
authors.lastname: Lind-Rasmussen
authors.forename: Jawdat
authors.initials: J
authors.lastname: Abdulla
authors.forename: Per R
authors.initials: PR
authors.lastname: Hildebrandt
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D002302:Cardiac Output; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D054143:Heart Failure, Systolic / Q000097:blood* / Q000188:drug therapy / Q000503:physiopathology; D006760:Hospitalization / Q000639:trends*; D006801:Humans; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000097:blood*; D010045:Outpatients; D010446:Peptide Fragments / Q000097:blood*; D011379:Prognosis; D011446:Prospective Studies; D012042:Registries; D012720:Severity of Illness Index
chemical_list: D015415:Biomarkers; D002317:Cardiovascular Agents; D010446:Peptide Fragments; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain
keywords: Heart failure; NT-proBNP; Randomized clinical trial