Design and methodology of the NorthStar study: NT-proBNP stratified follow-up in outpatient heart failure clinics - A randomized Danish multicenter study

被引:18
作者
Schou, Morten [1 ]
Gustafsson, Finn [1 ]
Videbaek, Lars [1 ]
Markenvard, John [1 ]
Ulriksen, Hans [1 ]
Ryde, Henrik [1 ]
Jensen, Jens C. H. [1 ]
Nielsen, Tonny [1 ]
Knudsen, Anne S. [1 ]
Tuxen, Christian D. [1 ]
Handherg, Jens [1 ]
Sorensen, Per J. [1 ]
Espersen, Geert [1 ]
Lind-Rasmussen, Soren [1 ]
Keher, Niels [1 ]
Egstrup, Kenneth [1 ]
Nielsen, Olav W. [1 ]
Abdulla, Jawdat [1 ]
Nyvad, Ole [1 ]
Toft, Jens [1 ]
Hildebrandt, Per R. [1 ]
机构
[1] Frederiksberg Univ Hosp, Danish Heart Failure Clin Network, DK-2000 Frederiksberg, Denmark
关键词
D O I
10.1016/j.ahj.2008.06.007
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Randomized clinical trials have shown that newly discharged and symptomatic patients with chronic heart failure (CHF) benefit from follow-up in a specialized heart failure clinic (HFC). Clinical stable and educated patients are usually discharged from the HFC when on optimal therapy. It is unknown if risk stratification using natriuretic peptides could identify patients who would benefit from longer-term follow-up. Furthermore, data on the use of natriuretic peptides for monitoring of stable patients with CHIF are sparse. Aims The aims of this study are to test the hypothesis that clinical stable, educated, and medical optimized patients with CHIF with N-terminal pro-brain natriuretic peptide (NT-proBNP) levels >= 1,000 pg/mL benefit from long-term follow-up in an HFC and to assess the efficacy of NT-proBNP monitoring. Methods A total of 1,250 clinically stable, medically optimized, and educated patients with CHF will be enrolled from 18 HFCs in Denmark. The patients will be randomized to treatment in general practice, to a standard follow-up program in the HFC, or to NT-proBNP monitoring in the HFC. The patients will be followed for 30 months (median). Results Data will be collected from 2006 to 2009. At present (March 2008), 720 patients are randomized. Results expect to be presented in the second half of 2010. Conclusions This article outlines the design of the NorthStar study. If our hypotheses are confirmed, the results will help cardiologists and nurses in HFCs to identify patients who may benefit from long-term follow-up. Our results may also indicate whether patients with CHF will benefit from adding serial NT-proBNP measurements to usual clinical monitoring.
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页码:649 / 655
页数:7
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