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)

Morten Schou; Finn Gustafsson; Lars Videbaek; Helge Robert Lind Andersen; Jens Toft; Ole Nyvad; Henrik Ryde; Lars Fog; Jens C H Jensen; Olav Wendelboe Nielsen; Søren Poul Lind Rasmussen; Jawdat Abdulla; Per R Hildebrandt; on behalf of the NorthStar Investigators

doi:10.1093/eurjhf/hft037

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)

Morten Schou, Finn Gustafsson, Lars Videbaek, Helge Robert Lind Andersen, Jens Toft, Ole Nyvad, Henrik Ryde, Lars Fog, Jens C H Jensen, Olav Wendelboe Nielsen, Søren Poul Lind Rasmussen, Jawdat Abdulla, Per R Hildebrandt, on behalf of the NorthStar Investigators

Department of Clinical Medicine

24 Citations (Scopus)

Abstract

AimsThis study was designed to evaluate a new NT-proBNP monitoring concept in outpatients with systolic heart failure (HF).Methods and resultsThis 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.ConclusionsAdding 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 registrationwww.centerwatch: 173491 (NorthStar).

Original language	English
Journal	European Journal of Heart Failure
Pages (from-to)	818-827
Number of pages	10
ISSN	1388-9842
DOIs	https://doi.org/10.1093/eurjhf/hft037
Publication status	Published - Jul 2013

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Schou, M., Gustafsson, F., Videbaek, L., Andersen, H. R. L., Toft, J., Nyvad, O., Ryde, H., Fog, L., Jensen, J. C. H., Wendelboe Nielsen, O., Rasmussen, S. P. L., Abdulla, J., Hildebrandt, P. R., & Investigators, O. B. O. T. N. (2013). 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). European Journal of Heart Failure, 818-827. https://doi.org/10.1093/eurjhf/hft037

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). / Schou, Morten ; Gustafsson, Finn; Videbaek, Lars et al.
In: European Journal of Heart Failure, 07.2013, p. 818-827.

Research output: Contribution to journal › Journal article › Research › peer-review

Schou, M , Gustafsson, F, Videbaek, L, Andersen, HRL, Toft, J, Nyvad, O, Ryde, H, Fog, L, Jensen, JCH, Wendelboe Nielsen, O, Rasmussen, SPL, Abdulla, J, Hildebrandt, PR & Investigators, OBOTN 2013, '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)', European Journal of Heart Failure, pp. 818-827. https://doi.org/10.1093/eurjhf/hft037

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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 = "AimsThis study was designed to evaluate a new NT-proBNP monitoring concept in outpatients with systolic heart failure (HF).Methods and resultsThis 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.ConclusionsAdding 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 registrationwww.centerwatch: 173491 (NorthStar).",

author = "Morten Schou and Finn Gustafsson and Lars Videbaek and Andersen, {Helge Robert Lind} and Jens Toft and Ole Nyvad and Henrik Ryde and Lars Fog and Jensen, {Jens C H} and {Wendelboe Nielsen}, Olav and Rasmussen, {S{\o}ren Poul Lind} and Jawdat Abdulla and Hildebrandt, {Per R} and Investigators, {on behalf of the NorthStar}",

year = "2013",

month = jul,

doi = "10.1093/eurjhf/hft037",

language = "English",

pages = "818--827",

journal = "European Journal of Heart Failure",

issn = "1388-9842",

publisher = "JohnWiley & Sons Ltd",

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TY - JOUR

T1 - Adding serial N-terminal pro brain natriuretic peptide measurements to optimal clinical management in outpatients with systolic heart failure

T2 - a multicentre randomized clinical trial (NorthStar monitoring study)

AU - Schou, Morten

AU - Gustafsson, Finn

AU - Videbaek, Lars

AU - Andersen, Helge Robert Lind

AU - Toft, Jens

AU - Nyvad, Ole

AU - Ryde, Henrik

AU - Fog, Lars

AU - Jensen, Jens C H

AU - Wendelboe Nielsen, Olav

AU - Rasmussen, Søren Poul Lind

AU - Abdulla, Jawdat

AU - Hildebrandt, Per R

AU - Investigators, on behalf of the NorthStar

PY - 2013/7

Y1 - 2013/7

N2 - AimsThis study was designed to evaluate a new NT-proBNP monitoring concept in outpatients with systolic heart failure (HF).Methods and resultsThis 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.ConclusionsAdding 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 registrationwww.centerwatch: 173491 (NorthStar).

AB - AimsThis study was designed to evaluate a new NT-proBNP monitoring concept in outpatients with systolic heart failure (HF).Methods and resultsThis 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.ConclusionsAdding 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 registrationwww.centerwatch: 173491 (NorthStar).

U2 - 10.1093/eurjhf/hft037

DO - 10.1093/eurjhf/hft037

M3 - Journal article

C2 - 23507787

SN - 1388-9842

SP - 818

EP - 827

JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

ER -