Evidence map›Paper›PMID 29433525›Full record

ArticleTrials2018

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.

Dong-Ju Choi, Chan Soon Park, Jin Joo Park, Hae-Young Lee, Seok-Min Kang, Byung-Su Yoo, Eun-Seok Jeon, Seok Keun Hong, Joon-Han Shin, Myung-A Kim and 5 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03209180 (Assessment of Clinical Effect and Treatment Quality of Rapid Release Carvedilol Versus SLOW Release Carvedilol-SR in HEART FAILURE Patient), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 47% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03209180 phase4unknown statusnot on this map

Assessment of Clinical Effect and Treatment Quality of Rapid Release Carvedilol Versus SLOW Release Carvedilol-SR in HEART FAILURE Patient (SLOW-HF): A Prospective Randomized, Open-label, Multicenter Study

TypeinterventionalSponsorSeoul National University Bundang HospitalRan2016 to 2018Enrolled320ConditionsHeart Failure With Reduced Ejection FractionArmsCarVeDilol-SR (Slow Release), Carvedilol IR (Immediate Release)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 10 institutions in 1 country.

Dong-Ju ChoiDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Chan Soon ParkDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Jin Joo ParkDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea. jinjooparkmd@gmail.com.ORCID http://orcid.org/0000-0001-9611-1490
Hae-Young LeeDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.
Seok-Min KangDivision of Cardiology, Yonsei University Severance Hospital, Seoul, South Korea.
Byung-Su YooDivision of Cardiology, Yonsei University Wonju Severance Christian Hospital, Wonju, South Korea.
Eun-Seok JeonDepartment of Internal Medicine, Sungkyunkwan University College of Medicine, Samsung Medical Center, Seoul, South Korea.
Seok Keun HongDivision or Cardiology, Sejong General Hospital, Bucheon, Gyeonggi-do, South Korea.
Joon-Han ShinDivision of Cardiology, Ajou University Hospital, Suwon, Gyeonggi-do, South Korea.
Myung-A KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Boramae Medical Center, Seoul, South Korea.
Dae-Gyun ParkCardiovascular Center, Hallym University Medical Center, Seoul, South Korea.
Eung-Ju KimDivision of Cardiology, Korea University Guro Hospital, Seoul, South Korea.
Soon-Jun HongDivision of Cardiology, Korea University Anam Hospital, Seoul, South Korea.
Seok Yeon KimDepartment of Internal Medicine, Seoul Medical center, Seoul, South Korea.
Jae-Joong KimDepartment of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Korea University Medical Center · KRSeoul National University Bundang Hospital · KRYonsei University · KRAjou University Hospital · KRHallym University Medical Center · KRSamsung Medical Center · KRSeoul Medical Center · KRSeoul National University · KRSeoul National University Hospital · KRUlsan College · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCarvedilol 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/

designPatients 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 registrationClinicalTrials.gov, ID: NCT03209180 . Registered on 6 July 2017.

Indexed as

Adrenergic beta-AntagonistsBiomarkersCarvedilolClinical Trials, Phase IV as TopicDelayed-Action PreparationsDrug CompoundingFemaleHeart FailureHumansMaleMulticenter Studies as TopicNatriuretic Peptide, BrainPeptide FragmentsProspective StudiesRandomized Controlled Trials as TopicRecovery of FunctionAdrenergic beta-AntagonistsBiomarkersCarvedilolDelayed-Action PreparationsNatriuretic Peptide, BrainPeptide Fragmentspro-brain natriuretic peptide (1-76)CarvedilolClinical efficacyHeart failure with reduced ejection fractionImmediate releaseNT-proBNPSlow release

Identifiers

PMID29433525
PMCPMC5809818
OpenAlexW2788911095

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.