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Assessment of clinical effect and treatment quality of immediate-release carvedilol-IR versus SLOW release carvedilol-SR in Heart Failure patients (SLOW-HF): study protocol for a randomized controlled trial

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Authors
Choi, Dong-Ju; Park, Chan Soon; Park, Jin Joo; Lee, Hae-Young; Kang, Seok-Min; Yoo, Byung-Su; Jeon, Eun-Seok; Hong, Seok Keun; Shin, Joon-Han; Kim, Myung-A; Park, Dae-Gyun; Kim, Eung-Ju; Hong, Soon-Jun; Kim, Seok Yeon; Kim, Jae-Joong
Issue Date
2018-02-13
Publisher
BioMed Central
Citation
Trials, 19(1):103
Keywords
Heart failure with reduced ejection fractionCarvedilolSlow releaseImmediate releaseClinicalefficacyNT-proBNP
Abstract
Background
Carvedilol is a non-selective, third-generation beta-blocker and is one of the cornerstones for treatment for patients with heart failure and reduced ejection fraction (HFrEF). However, due to its short half-life, immediate-release carvedilol (IR) needs to be prescribed twice a day. Recently, slow-release carvedilol (SR) has been developed. The aim of this study is to evaluate whether carvedilol-SR is non-inferior to standard carvedilol-IR in terms of its clinical efficacy in patients with HFrEF.

Methods/design
Patients with stable HFrEF will be randomly assigned in a 1:1 ratio to the carvedilol-SR group (160 patients) and the carvedilol-IR group (160 patients). Patients aged ≥ 20 years, with a left ventricular ejection fraction ≤ 40%, N-terminal pro B-natriuretic peptide (NT-proBNP) ≥ 125 pg/ml or BNP ≥ 35 pg/ml, who are clinically stable and have no evidence of congestion or volume retention, will be eligible. After randomization, patients will be followed up for 6 months. The primary endpoint is the change in NT-proBNP level from baseline to the study end. The secondary endpoints include the proportion of patients with NT-proBNP increment > 10% from baseline, composite of all-cause mortality and readmission, mortality rate, readmission rate, changes in blood pressure, quality of life, and drug compliance.

Discussions
The SLOW-HF trial is a prospective, randomized, open-label, phase-IV, multicenter study to evaluate the therapeutic efficacy of carvedilol-SR compared to carvedilol-IR in HFrEF patients. If carvedilol-SR proves to be non-inferior to carvedilol-IR, a once-daily prescription of carvedilol may be recommended for patients with HFrEF.
ISSN
1745-6215
Language
English
URI
http://hdl.handle.net/10371/139587
DOI
https://doi.org/10.1186/s13063-018-2470-5
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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