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A randomized controlled trial of lung ultrasound-guided therapy in heart failure (CLUSTER-HF study) - 25/08/20

Doi : 10.1016/j.ahj.2020.06.003 
Diego Araiza-Garaygordobil, MD a, , Rodrigo Gopar-Nieto, MD a, Pablo Martinez-Amezcua, MD, MHS b, Alejandro Cabello-López, MSc c, Gabriela Alanis-Estrada, MD a, Abraham Luna-Herbert a, Héctor González-Pacheco, MD a, Cynthia Paola Paredes-Paucar a, Martinez Daniel Sierra-Lara a, Jose Luis Briseño-De la Cruz, MD a, Hugo Rodriguez-Zanella, MD a, Marco Antonio Martinez-Rios a, Alexandra Arias-Mendoza, MD a
a Instituto Nacional de Cardiología “Ignacio Chávez,”, Mexico City, Mexico 
b Johns Hopkins University, Baltimore, MD, USA 
c Centro Médico Nacional “Siglo XXI,” Instituto Mexicano del Seguro Social, Mexico City, Mexico 

Reprint requests: Dr Diego Araiza-Garaygordobil, Coronary Care Unit, Instituto Nacional de Cardiología “Ignacio Chávez,”Juan Badiano 1, Belisario Dominguez Sección XVI, Tlalpan, 14030, Mexico City.Mexico

Abstract

Background

Lung ultrasound (LUS) has emerged as a new tool for the evaluation of congestion in heart failure (HF); incorporation of LUS during follow-up may detect congestion earlier and prompt interventions to prevent hospitalizations. The aim of this study was to test the hypothesis that the incorporation of LUS during follow-up of patients with HF may reduce the rate of adverse events compared with usual care.

Methods

In this single-blinded, randomized controlled trial, patients were randomized into an LUS-guided arm or control arm. Patients were followed in 4 prespecified visits during a 6-month period. LUS was performed in every patient visit in both groups; however, LUS results were available for the treating physician only in the LUS group. The primary outcome was the composite of urgent HF visits, rehospitalization for worsening HF, and death from any cause.

Results

One hundred twenty-six patients were randomized to either LUS (n = 63) or control (n = 63) (age 62.5 ± 10 years, median left ventricular ejection fraction 31%). The primary end point occurred in 30 (47.6%) patients in the control group and 20 (31.7%) patients in the LUS group (P = .041). LUS-guided treatment was associated with a 45% risk reduction in the primary end point (hazard ratio 0.55, 95% CI 0.31-0.98, P = .044), mainly driven by a reduction in urgent HF visits (hazard ratio 0.28, 95% CI 0.13-0.62, P = .001). No significant differences in rehospitalizations for HF or death were found.

Conclusions

Incorporation of LUS into clinical follow-up of patients with HF significantly reduced the risk of urgent visits for worsening HF.

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 Conflicts of interest: Dr Araiza-Garaygordobil has received institutional research grants from Novartis and reports speaking fees from Boehringer Ingelheim, Novartis, Roche Diagnostics, and Sanofi Aventis. Dr Briseño-De la Cruz has received speaking fees from Boehringer Ingelheim, Bayer, Boston Scientific, and Abbott. Dr Rodríguez-Zanella has received speaking fees from Novartis and Bayer. Dr Arias-Mendoza has served in the advisory board of Roche Diagnostics and reports speaking fees from Novo Nordisk, Novartis, Roche Diagnostics, and Sanofi Aventis. All other authors report no pertinent conflicts of interest.
 The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents.


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P. 31-39 - settembre 2020 Ritorno al numero
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