ISSN 2996-8215
International Journal of Cardiology | Vol. 1, No. 2, February 2010 | pp. 9–16
DOI: 10.46882/2010/IJC/000011
Original Research Article
Efficacy of a Novel Long-Acting Beta-Blocker in Patients with Chronic Heart Failure: A Randomized Controlled Trial
John A. Smith¹, Maria G. Silva², David M. Clark¹
¹Department of Cardiology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
²Division of Cardiovascular Medicine, University of São Paulo, São Paulo, Brazil
Abstract:
Chronic heart failure (CHF) remains a leading cause of cardiovascular morbidity globally. This study evaluated the efficacy and safety of a novel long-acting beta-blocker, BB-201, compared to standard-of-care carvedilol over a 12-month period. A double-blind, randomized, parallel-group trial was conducted involving 450 stable CHF patients with an ejection fraction less than or equal to 35%. Patients were randomized 1:1 to receive either BB-201 (mean dose 50 mg once daily) or carvedilol (mean dose 25 mg twice daily). The primary endpoint was the change in left ventricular ejection fraction (LVEF) measured via echocardiography. Secondary endpoints included N-terminal pro-bryn natriuretic peptide (NT-proBNP) levels, six-minute walk distance (6MWD), and all-cause mortality. At 12 months, the BB-201 group demonstrated a significant increase in LVEF compared to baseline (from 28.4% ± 3.1% to 36.2% ± 4.2%, p < 0.01), which was non-inferior and showed a trend toward superiority against the carvedilol group (34.8% ± 3.9%, p = 0.04 for superiority). NT-proBNP levels decreased by 42% in the BB-201 cohort versus 35% in the carvedilol cohort (p < 0.05). The 6MWD improved by 45 ± 8 meters with BB-201 and 38 ± 7 meters with carvedilol. Adverse event rates, including symptomatic bradycardia and hypotension, did not differ significantly between the groups (4.2% vs. 4.0%, p = 0.85). In conclusion, the novel long-acting beta-blocker BB-201 provides robust improvement in cardiac function and biomarker profiles in patients with stable chronic heart failure, offering a viable once-daily therapeutic alternative to standard multi-dose beta-blockade.
Keywords: Chronic heart failure, Beta-blockers, Left ventricular ejection fraction, Clinical trial, Echocardiography, Biomarkers
Received: November 12, 2009; Revised: December 28, 2009; Accepted: January 15, 2010; Published: February 10, 2010
Citation: International Journal of Cardiology, 2010, Vol. 1, No. 2, pp. 9–16, DOI: 10.46882/2010/IJC/000011