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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 FieldValueLanguage
dc.contributor.author강석민-
dc.date.accessioned2018-08-28T17:29:56Z-
dc.date.available2018-08-28T17:29:56Z-
dc.date.issued2018-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/162676-
dc.description.abstractBACKGROUND: 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.statementOfResponsibilityopen-
dc.formatapplication/pdf-
dc.languageEnglish-
dc.publisherBioMed Central-
dc.relation.isPartOfTRIALS-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.titleAssessment 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.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Internal Medicine-
dc.contributor.googleauthorDong-Ju Choi-
dc.contributor.googleauthorChan Soon Park-
dc.contributor.googleauthorJin Joo Park-
dc.contributor.googleauthorHae-Young Lee-
dc.contributor.googleauthorSeok-Min Kang-
dc.contributor.googleauthorByung-Su Yoo-
dc.contributor.googleauthorEun-Seok Jeon-
dc.contributor.googleauthorSeok Keun Hong-
dc.contributor.googleauthorJoon-Han Shin-
dc.contributor.googleauthorMyung-A Kim-
dc.contributor.googleauthorDae-Gyun Park-
dc.contributor.googleauthorEung-Ju Kim-
dc.contributor.googleauthorSoon-Jun Hong-
dc.contributor.googleauthorSeok Yeon Kim-
dc.contributor.googleauthorJae-Joong Kim-
dc.identifier.doi10.1186/s13063-018-2470-5-
dc.contributor.localIdA00037-
dc.relation.journalcodeJ02759-
dc.identifier.eissn1745-6215-
dc.identifier.pmid29433525-
dc.subject.keywordCarvedilol-
dc.subject.keywordClinical efficacy-
dc.subject.keywordHeart failure with reduced ejection fraction-
dc.subject.keywordImmediate release-
dc.subject.keywordNT-proBNP-
dc.subject.keywordSlow release-
dc.contributor.alternativeNameKang, Seok Min-
dc.contributor.affiliatedAuthorKang, Seok Min-
dc.citation.volume19-
dc.citation.number1-
dc.citation.startPage103-
dc.identifier.bibliographicCitationTRIALS, Vol.19(1) : 103, 2018-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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