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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
DC Field | Value | Language |
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dc.contributor.author | 강석민 | - |
dc.date.accessioned | 2018-08-28T17:29:56Z | - |
dc.date.available | 2018-08-28T17:29:56Z | - |
dc.date.issued | 2018 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/162676 | - |
dc.description.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. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03209180 . Registered on 6 July 2017. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | BioMed Central | - |
dc.relation.isPartOf | TRIALS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | Dong-Ju Choi | - |
dc.contributor.googleauthor | Chan Soon Park | - |
dc.contributor.googleauthor | Jin Joo Park | - |
dc.contributor.googleauthor | Hae-Young Lee | - |
dc.contributor.googleauthor | Seok-Min Kang | - |
dc.contributor.googleauthor | Byung-Su Yoo | - |
dc.contributor.googleauthor | Eun-Seok Jeon | - |
dc.contributor.googleauthor | Seok Keun Hong | - |
dc.contributor.googleauthor | Joon-Han Shin | - |
dc.contributor.googleauthor | Myung-A Kim | - |
dc.contributor.googleauthor | Dae-Gyun Park | - |
dc.contributor.googleauthor | Eung-Ju Kim | - |
dc.contributor.googleauthor | Soon-Jun Hong | - |
dc.contributor.googleauthor | Seok Yeon Kim | - |
dc.contributor.googleauthor | Jae-Joong Kim | - |
dc.identifier.doi | 10.1186/s13063-018-2470-5 | - |
dc.contributor.localId | A00037 | - |
dc.relation.journalcode | J02759 | - |
dc.identifier.eissn | 1745-6215 | - |
dc.identifier.pmid | 29433525 | - |
dc.subject.keyword | Carvedilol | - |
dc.subject.keyword | Clinical efficacy | - |
dc.subject.keyword | Heart failure with reduced ejection fraction | - |
dc.subject.keyword | Immediate release | - |
dc.subject.keyword | NT-proBNP | - |
dc.subject.keyword | Slow release | - |
dc.contributor.alternativeName | Kang, Seok Min | - |
dc.contributor.affiliatedAuthor | Kang, Seok Min | - |
dc.citation.volume | 19 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 103 | - |
dc.identifier.bibliographicCitation | TRIALS, Vol.19(1) : 103, 2018 | - |
dc.identifier.rimsid | 60254 | - |
dc.type.rims | ART | - |
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