Abstract 2554: STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients with Advanced Heart Failure
Introduction. STARBRITE, a multicenter randomized trial, tested whether outpatient diuretic management guided by BNP and clinical assessment resulted in more days alive and not hospitalized over 90 days after the first clinic visit compared with clinical assessment alone.
Methods. A total of 130 pts from 3 sites with LVEF <35% were enrolled during hospitalization for acute HF. Pts were assigned to therapy guided by BNP and clinical assessment (BNP) or clinical assessment alone (Congestion Score). The goal in both arms was resolution of congestion without hypotension or renal dysfunction. In the BNP arm, therapy was adjusted to maintain BNP less than 2× that at discharge. Pts were excluded if they had Cr >3.5 mg/dL or an ACS. Pts received follow-up in the HF clinics of the participating centers. BNP was measured using a rapid assay test. Clinicians were blinded to BNP in Congestion Score pts.
Results. Baseline features were: age 59.8 yrs (50.6, 71.9); male 70%; SBP 108 mm Hg (95, 122); LVEF 20% (15, 25); Na 137 mmol/L (134, 139); BUN 29 mg/dL (21, 43); Cr 1.4 mg/dL (1.1, 1.8); admission BNP 640 pcg/mL (245, 1450); discharge BNP 445.5 pcg/mL (191, 1030). A total of 3.1% of pts died; 35.4% of pts were hospitalized. The BNP arm showed: a trend towards more days alive and not hospitalized over 90 days (HR 0.72; 95% CI, 0.41, 1.27; P=0.25); lower BNP (P=0.02); lower BUN (24 mg/dL vs. 29 mg/dL; P=0.07); and no significant difference in Cr (1.4 mg/dL vs. 1.5 mg/dL; P=0.47) or SBP. BNP arm pts received significantly more ACE inhibitors, beta-blockers, and fewer increases in diuretics.
Conclusions. Therapy guided by BNP and clinical assessment was associated with greater use of evidence-based medications and significantly lower BNP. The BNP arm did not have any adverse effects on renal function or BP. STARBRITE suggests that using BNP and clinical assessment to guide HF treatment may improve clinical outcomes and establishes an approach to testing strategies and targets for therapy in larger trials.