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Extended heart failure clinic follow-up in low-risk patients: a randomized clinical trial (NorthStar)
Morten Schou1, Finn Gustafsson, Lars Videbaek
1Department of Cardiology and Endocrinology, Frederiksberg University Hospital, DK-2000 Frderiksberg, Denmark. m.schou@dadlnet.dk
Insights
Stable heart failure patients on optimal medical therapy do not benefit from extended specialized clinic follow-up. General practitioners can safely manage these heart failure patients.
Area of Science:
- Cardiology
- Heart Failure Management
Background:
- Current guidelines recommend specialized heart failure clinics (HFCs) for outpatient follow-up.
- The optimal duration and patient selection for extended HFC programs remain unclear.
- It is unknown if high-risk patients, identified by NT-proBNP, benefit from prolonged HFC care.
Purpose of the Study:
- To determine if extended follow-up in a specialized heart failure clinic (HFC) improves outcomes for stable systolic heart failure patients on optimal medical therapy compared to general practitioner (GP) care.
- To assess if high-risk patients, defined by NT-proBNP levels, benefit from extended HFC follow-up.
Main Methods:
- A multi-center randomized trial assigned 921 stable systolic heart failure outpatients to either extended HFC follow-up or usual care by their GP.
- The primary endpoint was a composite of death or cardiovascular admission.
- Secondary endpoints included mortality, heart failure admissions, quality of life, and healthcare utilization.
Main Results:
- No significant difference was observed in the primary composite endpoint between the HFC and GP groups (HR: 1.17, P=0.149).
- Secondary endpoints, including mortality and HF admissions, also showed no significant differences between the groups.
- Extended HFC follow-up did not benefit high-risk patients identified by NT-proBNP ≥1000 pg/mL (P=0.721).
Conclusions:
- Stable heart failure patients on optimal medical therapy do not benefit from long-term specialized HFC follow-up, regardless of NT-proBNP levels.
- General practitioners are capable of safely managing heart failure patients with mild to moderate symptoms in a universal healthcare system.
- Current practice of extended HFC follow-up for all stable heart failure patients may not be necessary.
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).
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