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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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dc.contributor.authorChoi, DJ-
dc.contributor.authorPark, CS-
dc.contributor.authorPark, JJ-
dc.contributor.authorLee, HY-
dc.contributor.authorKang, SM-
dc.contributor.authorYoo, BS-
dc.contributor.authorJeon, ES-
dc.contributor.authorHong, SK-
dc.contributor.authorShin, JH-
dc.contributor.authorKim, MA-
dc.contributor.authorPark, DG-
dc.contributor.authorKim, EJ-
dc.contributor.authorHong, SJ-
dc.contributor.authorKim, SY-
dc.contributor.authorKim, JJ-
dc.date.accessioned2019-11-13T00:17:30Z-
dc.date.available2019-11-13T00:17:30Z-
dc.date.issued2018-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/16683-
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 /= 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.
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dc.language.isoen-
dc.subject.MESHAdrenergic beta-Antagonists-
dc.subject.MESHBiomarkers-
dc.subject.MESHCarvedilol-
dc.subject.MESHClinical Trials, Phase IV as Topic-
dc.subject.MESHDelayed-Action Preparations-
dc.subject.MESHDrug Compounding-
dc.subject.MESHFemale-
dc.subject.MESHHeart Failure-
dc.subject.MESHHumans-
dc.subject.MESHMale-
dc.subject.MESHMulticenter Studies as Topic-
dc.subject.MESHNatriuretic Peptide, Brain-
dc.subject.MESHPeptide Fragments-
dc.subject.MESHProspective Studies-
dc.subject.MESHRandomized Controlled Trials as Topic-
dc.subject.MESHRecovery of Function-
dc.subject.MESHRepublic of Korea-
dc.subject.MESHStroke Volume-
dc.subject.MESHTime Factors-
dc.subject.MESHTreatment Outcome-
dc.subject.MESHVentricular Function, Left-
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.identifier.pmid29433525-
dc.identifier.urlhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5809818/-
dc.subject.keywordHeart failure with reduced ejection fraction-
dc.subject.keywordCarvedilol-
dc.subject.keywordSlow release-
dc.subject.keywordImmediate release-
dc.subject.keywordClinical efficacy-
dc.subject.keywordNT-proBNP-
dc.contributor.affiliatedAuthor신, 준한-
dc.type.localJournal Papers-
dc.identifier.doi10.1186/s13063-018-2470-5-
dc.citation.titleTrials-
dc.citation.volume19-
dc.citation.number1-
dc.citation.date2018-
dc.citation.startPage103-
dc.citation.endPage103-
dc.identifier.bibliographicCitationTrials, 19(1). : 103-103, 2018-
dc.identifier.eissn1745-6215-
dc.relation.journalidJ017456215-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Cardiology
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