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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)
Author(s) -
Schou Morten,
Gustafsson Finn,
Videbaek Lars,
Andersen Helge,
Toft Jens,
Nyvad Ole,
Ryde Henrik,
Fog Lars,
Jensen Jens C.H.,
Nielsen Olav W.,
LindRasmussen Soren,
Abdulla Jawdat,
Hildebrandt Per R.
Publication year - 2013
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1093/eurjhf/hft037
Subject(s) - medicine , heart failure , hazard ratio , randomization , clinical endpoint , natriuretic peptide , confidence interval , n terminal pro brain natriuretic peptide , cardiology , ejection fraction , randomized controlled trial , clinical trial , prospective cohort study
Aims This study was designed to evaluate a new NT‐proBNP monitoring concept in outpatients with systolic heart failure (HF). Methods and 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. Trial registration www.centerwatch : 173491 (NorthStar).