临床终点
随机对照试验
射血分数
急性失代偿性心力衰竭
利钠肽
医学
急诊医学
内科学
心脏病学
心力衰竭
作者
Jesús Álvarez‐García,Anuradha Lala,Mercedes Rivas‐Lasarte,C De Rueda,Danielle L. Brunjes,Sara Lozano-Jiménez,Cristina García-Sebastián,Sumeet S. Mitter,Paloma Remior,Marta Jiménez-Blanco Bravo,Sofia Prado,Maya Barghash,Eduardo González-Ferrer,Jennifer Ullman,Marta Cobo‐Marcos,Javier Segovia,José Luis Zamorano,Sean Pinney,Donna Mancini
标识
DOI:10.1016/j.jchf.2024.01.002
摘要
Incomplete treatment of congestion often leads to worsening heart failure (HF). The remote dielectric sensing (ReDS) system is an electromagnetic energy–based technology that accurately quantifies changes in lung fluid concentration noninvasively. This study sought to assess whether an ReDS-guided strategy during acutely decompensated HF hospitalization is superior to routine care for improving outcomes at 1 month postdischarge. ReDS-SAFE HF (Use of ReDS for a SAFE discharge in patients with acute Heart Failure) was an investigator-initiated, multicenter, single-blind, randomized, proof-of-concept trial in which 100 patients were randomized to a routine care strategy, with discharge criteria based on current clinical practice, or an ReDS-guided decongestion strategy, with discharge criteria requiring an ReDS value of ≤35%. ReDS measurements were performed daily and at a 7-day follow-up visit, with patients and treating physicians in the routine care arm blinded to the results. The primary outcome was a composite of unplanned visits for HF, HF rehospitalization, or death at 1 month after discharge. The mean age was 67 ± 14 years, and 74% were male. On admission, left ventricular ejection fraction was 37% ± 16%, and B-type natriuretic peptide was 940 pg/L (Q1-Q3: 529-1,665 pg/L). The primary endpoint occurred in 10 (20%) patients in the routine care group and 1 (2%) in the ReDS-guided strategy group (log-rank P = 0.005). The ReDS-guided strategy group experienced a lower event rate, with an HR of 0.094 (95% CI: 0.012-0.731; P = 0.003), and a number of patients needed to treat of 6 to avoid an event (95% CI: 3-17), mainly resulting from a decrease in HF readmissions. The median length of stay was 2 days longer in the ReDS-guided group vs the routine care group (8 vs 6; P = 0.203). A ReDS-guided strategy to treat congestion improved 1-month prognosis postdischarge in this proof-of-concept study, mainly because of a decrease of the number of HF readmissions. (Use of ReDS for a SAFE discharge in patients with acute Heart Failure [ReDS-SAFE HF]; NCT04305717)
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