Extended heart failure clinic follow-up in low-risk patients: a randomized clinical trial (NorthStar).

BACKGROUND: Outpatient 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 RESULTS: In 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). CONCLUSION: Irrespective 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).

Incidence and predictors of hospitalization or death in patients managed in multidisciplinary heart failure clinics.

AIMS: To assess the rates of death or hospitalization in outpatients with heart failure (HF) followed in multidisciplinary, nurse-based HF clinics and to compare the rates with published data from the literature. A second aim was to identify risk factors for death or hospital admission. METHODS AND RESULTS: A total of 4012 consecutive outpatients referred for HF management in 18 Danish HF clinics were included. Clinical data were collected prospectively. Outcome data were obtained from a validated, national registry. Mean follow-up time was 580 days. The mean age of patients was 69 years, 83% had left ventricular systolic dysfunction and 52% had been hospitalized within 90 days prior to referral to the HF clinic. The 6 and 12 month rates of hospitalization or death were 31 and 42%. Hospitalization or death was significantly predicted by age 1.12 (1.05-1.19), diabetes 1.21 (1.03-1.42), serum creatinine 1.03 (1.02-1.04), NYHA III and IV 1.32 (1.15-1.52), and hospitalization prior to referral to the HF clinic 1.81 (1.57-2.08). CONCLUSIONS: Event rates in this cohort were lower than most published data from HF clinic populations. Factors such as advanced age, NYHA class, and prior hospitalization predict poor outcome in patients managed in multidisciplinary HF clinics.

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

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 CHF are sparse. AIMS: The aims of this study are to test the hypothesis that clinical stable, educated, and medical optimized patients with CHF with N-terminal pro-brain natriuretic peptide (NT-proBNP) levels > or = 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.