1 The Faculty of Medicine, Aalborg University, VBN2 Aalborg University Hospital, The Faculty of Medicine, Aalborg University, VBN3 Klinik Hjerte-Lunge, The Faculty of Medicine, Aalborg University, VBN4 Hjertemedicin (Kardiologi), The Faculty of Medicine, Aalborg University, VBN5 Department of Cardiology and Endocrinology6 Department of Cardiology, Aalborg Hospital, Aalborg7 Department of Internal Medicine, Hematology, Haderslev Hospital8 unknown
A randomized clinical trial (NorthStar)
BackgroundOutpatient follow-up in specialized heart failure clinics (HFCs) is recommended by current guidelines and implemented in most European countries, but the optimal duration of HFC programmes has not been established. Nor is it known whether all or only high-risk patients, e.g. identified by NT-proBNP, might benefit from an extended HFC follow-up.Methods and resultsIn a multi-centre setting, we randomly assigned 921 clinically stable systolic heart failure (HF) outpatients on optimal medical therapy to undergo either an extended follow-up in the HFC (n = 461) or referral back to their general practitioner (GP) (n = 460). The primary composite endpoint was death or a cardiovascular admission. Secondary endpoints included mortality, an HF admission, quality of life, number of days admitted, and number of admissions. The median age of the patients was 69 years; 23% were females; the median left ventricular ejection fraction was 0.30; and the median NT-proBNP was 801 pg/mL; 89% were in NYHA class I-II. The median follow-up was 2.5 years. Time-to-event did not differ between groups (HFC vs. GP) (HR: 1.17, 95% CI: 0.95-1.45, P = 0.149). The two groups did not differ with respect to any of the secondary endpoints at the follow-up (P> 0.05 for all). In high-risk patients identified by NT-proBNP ≥1000 pg/mL, no benefit from HFC follow-up was found (P = 0.721).ConclusionIrrespective of the level of NT-proBNP stable HF patients on optimal medical therapy do not benefit from long-term follow-up in a specialized HFC in a publicly funded universal access healthcare system. Heart failure patients on optimal medical therapy with mild or moderate symptoms are safely managed by their personal GP.Trial Registration: www.Centerwatch.com: 173491 (NorthStar).
European Heart Journal (online), 2013, Vol 34, Issue 6, p. 432-442
Heart failure clinic; NT-ProBNP; Randomized clinical trial; Systolic heart failure; Aged; Aged, 80 and over; Cardiac Resynchronization Therapy; Cardiotonic Agents; Cause of Death; Coronary Care Units; Family Practice; Female; Heart Failure; Hospitalization; Humans; Kaplan-Meier Estimate; Long-Term Care; Male; Middle Aged; Natriuretic Peptide, Brain; Peptide Fragments; Referral and Consultation; Treatment Outcome; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't