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Trials. 2018 Feb 13;19(1):103. doi: 10.1186/s13063-018-2470-5.

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.

Author information

1
Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
2
Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea. jinjooparkmd@gmail.com.
3
Cardiovascular Center and Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro 173 Beon-gil, Bundang-gu, Gyeonggi-do, 13620, South Korea. jinjooparkmd@gmail.com.
4
Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.
5
Division of Cardiology, Yonsei University Severance Hospital, Seoul, South Korea.
6
Division of Cardiology, Yonsei University Wonju Severance Christian Hospital, Wonju, South Korea.
7
Department of Internal Medicine, Sungkyunkwan University College of Medicine, Samsung Medical Center, Seoul, South Korea.
8
Division or Cardiology, Sejong General Hospital, Bucheon, Gyeonggi-do, South Korea.
9
Division of Cardiology, Ajou University Hospital, Suwon, Gyeonggi-do, South Korea.
10
Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Boramae Medical Center, Seoul, South Korea.
11
Cardiovascular Center, Hallym University Medical Center, Seoul, South Korea.
12
Division of Cardiology, Korea University Guro Hospital, Seoul, South Korea.
13
Division of Cardiology, Korea University Anam Hospital, Seoul, South Korea.
14
Department of Internal Medicine, Seoul Medical center, Seoul, South Korea.
15
Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.

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.

KEYWORDS:

Carvedilol; Clinical efficacy; Heart failure with reduced ejection fraction; Immediate release; NT-proBNP; Slow release

PMID:
29433525
PMCID:
PMC5809818
DOI:
10.1186/s13063-018-2470-5
[Indexed for MEDLINE]
Free PMC Article

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