Evidence map›Paper›PMID 36647691›Full record

ArticleESC heart failure2023

Iron therapy and severe arrhythmias in HFrEF: rationale, study design, and baseline results of the RESAFE-HF trial.

Constantinos Bakogiannis, Dimitrios Mouselimis, Anastasios Tsarouchas, Christodoulos E Papadopoulos, Efstratios K Theofillogiannakos, Elmira Lechat, Antonios P Antoniadis, Efstathios D Pagourelias, Ioannis Kelemanis, Stergios Tzikas and 5 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in ESC heart failure, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04974021 (An Open Label,Single-center, Non-interventional Prospective Study to Determine the Efficacy of Iron Therapy Using Intravenous Ferric Carboxymaltose and Its Effect in Reducing Arrhythmic Events in Participants With Iron Deficiency and HFrEF), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.5field-weighted citation impact, top 16% 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.

NCT04974021 unknown statusnot on this map

An Open Label,Single-center, Non-interventional Prospective Study to Determine the Efficacy of Iron Therapy Using Intravenous Ferric Carboxymaltose and Its Effect in Reducing Arrhythmic Events in Participants With Iron Deficiency and HFrEF

TypeobservationalSponsorAristotle University Of ThessalonikiRan2019 to 2021Enrolled106ConditionsFerric Carboxymaltose, Heart Failure With Reduced Ejection Fraction, Arrhythmias, CardiacArmsFerric carboxymaltose
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 7 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 3 institutions in 3 countries.

Constantinos BakogiannisThird Cardiology Department, School of Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.ORCID 0000-0002-1132-9835
Dimitrios MouselimisThird Cardiology Department, School of Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.ORCID 0000-0003-0266-302X
Anastasios TsarouchasThird Cardiology Department, School of Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.ORCID 0000-0003-2883-2688
Christodoulos E PapadopoulosThird Cardiology Department, School of Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Efstratios K TheofillogiannakosThird Cardiology Department, School of Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Elmira LechatVifor Pharma Management Ltd., Glattbrugg, Switzerland.
Antonios P AntoniadisThird Cardiology Department, School of Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Efstathios D PagoureliasThird Cardiology Department, School of Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Ioannis KelemanisThird Cardiology Department, School of Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Stergios TzikasThird Cardiology Department, School of Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Nikolaos FragakisThird Cardiology Department, School of Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Georgios K EfthimiadisFirst Cardiology Department, School of Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Theodoros D KaramitsosFirst Cardiology Department, School of Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Michael DoumasSecond Propaedeutics Department of Internal Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Vassilios P VassilikosThird Cardiology Department, School of Medicine, Hippokration General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Aristotle University of Thessaloniki · GRGeorgetown University · USVifor Pharma (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe Iron Intravenous Therapy in Reducing the burden of Severe Arrhythmias in HFrEF (RESAFE-HF) registry study aims to provide real-word evidence on the impact of intravenous ferric carboxymaltose (FCM) on the arrhythmic burden of patients with heart failure with reduced ejection fraction (HFrEF), iron deficiency (ID), and implanted cardiac implantable electronic devices (CIEDs). METHODS AND

resultsThe RESAFE-HF (NCT04974021) study was designed as a prospective, single-centre, and open-label registry study with baseline, 3, 6, and 12 month visits. Adult patients with HFrEF and CIEDs scheduled to receive IV FCM as treatment for ID as part of clinical practice were eligible to participate. The primary endpoint is the composite iron-related endpoint of haemoglobin ≥ 12 g/dL, ferritin ≥ 50 ng/L, and transferrin saturation > 20%. Secondary endpoints include unplanned HF-related hospitalizations, ventricular tachyarrhythmias detected by CIEDs and Holter monitors, echocardiographic markers, functional status (VO

conclusionsThe RESAFE-HF trial is expected to provide evidence on the effect of treating ID with FCM in HFrEF based on real-world data. Special focus will be given on the arrhythmic burden post-FCM administration.

Indexed as

Arrhythmias, CardiacHeart FailureIronAdultAgedDouble-Blind MethodFemaleFerric CompoundsHumansIron DeficienciesMaleMaltoseProspective StudiesQuality of LifeStroke VolumeTreatment Outcomeferric carboxymaltoseFerric CompoundsIronMaltoseArrhythmiaFCMFerric carboxymaltoseHeart failureHFrEFIron deficiency

Identifiers

PMID36647691
PMCPMC10053179
OpenAlexW4316673022

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.