Journal of cardiac failure
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Randomized Controlled Trial Multicenter Study Comparative Study
The STARBRITE trial: a randomized, pilot study of B-type natriuretic peptide-guided therapy in patients with advanced heart failure.
STARBRITE, a multicenter randomized pilot trial, tested whether outpatient diuretic management guided by B-type natriuretic peptide (BNP) and clinical assessment resulted in more days alive and not hospitalized over 90 days compared with clinical assessment alone. ⋯ BNP strategy was not associated with more days alive and not hospitalized, but the strategy appeared to be safe and was associated with increased use of evidence-based medications.
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Two major problems for translating gene therapy for heart failure therapy are: safe and efficient delivery and the inability to establish a relationship between vector exposure and in vivo effects. We present a pharmacokinetics (PK) analysis of molecular cardiac surgery with recirculating delivery (MCARD) of scAAV6-βARKct. MCARD's stable cardiac specific delivery profile was exploited to determine vector exposure, half-life, and systemic clearance. ⋯ MCARD may offer a viable method to establish a relationship between vector exposure and in vivo transduction. Using this methodology, it may be possible to address a critical need for establishing an effective therapeutic window.