Evidence map›Paper›PMID 31631048›Full record

ArticleRevista espanola de cardiologia (English ed.)2020

Ivabradine for chronic heart rate control in persistent atrial fibrillation. Design of the BRAKE-AF project.

Adolfo Fontenla, María López-Gil, Juan Tamargo-Menéndez, Roberto Matía-Francés, Ricardo Salgado-Aranda, Juan Ramón Rey-Blas, Ángel Miracle-Blanco, Elena Mejía-Martínez, Agustín Pastor-Fuentes, Jorge Toquero-Ramos and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Publisher
In one paragraph

Article in Revista espanola de cardiologia (English ed.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03718273 (A Phase III Clinical Trial to Compare Ivabradine Versus Digoxin in the Heart Rate Control in Patients With Permanent Atrial Fibrillation Under Treatment With Beta-blockers or Calcium Antagonists.), 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
1.8field-weighted citation impact, top 13% 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.

NCT03718273 phase3completednot on this map

A Phase III Clinical Trial to Compare Ivabradine Versus Digoxin in the Heart Rate Control in Patients With Permanent Atrial Fibrillation Under Treatment With Beta-blockers or Calcium Antagonists.

TypeinterventionalSponsorAdolfo FontenlaRan2018 to 2022Enrolled68ConditionsAtrial Fibrillation, Heart DiseasesArmsIvabradine, Digoxin
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 15 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 1 country.

Adolfo FontenlaServicio de Cardiología, Hospital Universitario 12 de Octubre, Madrid, Spain. Electronic address: drfontenla@gmail.com.
María López-GilServicio de Cardiología, Hospital Universitario 12 de Octubre, Madrid, Spain.
Juan Tamargo-MenéndezDepartamento de Farmacología, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.
Roberto Matía-FrancésMadrid Servicio de Cardiología, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Ricardo Salgado-ArandaServicio de Cardiología, Complejo Hospitalario de Burgos, Burgos, Spain.
Juan Ramón Rey-BlasServicio de Cardiología, Hospital Universitario La Paz, Madrid, Spain.
Ángel Miracle-BlancoServicio de Cardiología, Hospital Rey Juan Carlos, Móstoles, Madrid, Spain.
Elena Mejía-MartínezServicio de Cardiología, Fundación Jiménez-Díaz, Madrid, Spain.
Agustín Pastor-FuentesServicio de Cardiología, Hospital de Getafe, Getafe, Madrid, Spain.
Jorge Toquero-RamosServicio de Cardiología, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain.
Miguel Ángel AriasServicio de Cardiología, Hospital Virgen de la Salud, Toledo, Spain.
Isabel MontillaServicio de Cardiología, Hospital Universitario 12 de Octubre, Madrid, Spain.
Agustín Gómez de la CámaraUnidad de Investigación Clínica en Ensayos Clínicos (UICEC), Hospital 12 de Octubre, Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.
Fernando ArribasServicio de Cardiología, Hospital Universitario 12 de Octubre, Madrid, Spain.
BRAKE-AF investigators
Hospital Universitario 12 De Octubre · ESCentro de Investigación Biomédica en Red de Epidemiología y Salud Pública · ESHospital Universitario de Burgos · ESHospital Universitario de Getafe · ESHospital Universitario Fundación Jiménez Díaz · ESHospital Universitario La Paz · ESHospital Universitario Puerta de Hierro Majadahonda · ESHospital Universitario Ramón y Cajal · ESHospital Universitario Rey Juan Carlos · ESHospital Virgen de la Salud · ESUniversidad Complutense de Madrid · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

INTRODUCTION AND

objectivesIvabradine is an inhibitor of the If channel, the main determinant of the pacemaker function of the sinus node. The drug has been approved for the treatment of angina and heart failure. There is some evidence of its role as an inhibitor of atrial-ventricular node (AVN) conduction. The aim of the BRAKE-AF project is to assess ivabradine use for rate control in atrial fibrillation (AF).

methodsA multicenter, randomized, parallel, open-label, noninferiority phase III clinical trial will be conducted to compare ivabradine vs digoxin in 232 patients with uncontrolled permanent AF despite beta-blockers or calcium channel blockers. The primary efficacy endpoint is the reduction in daytime heart rate measured by 24-hour Holter monitoring at 3 months. This clinical trial will be supported by an electrophysiological study of the effect of ivabradine on the action potential of the human AVN. To do this, an experimental model will be used with Chinese hamster ovarium cells transfected with the DNA encoding the expression of the t channels involved in this action potential and recording of the ionic currents with patch clamp techniques.

resultsNew data will be obtained on the effect of ivabradine on the human AVN and its safety and efficacy in patients with permanent AF.

conclusionsThe results of the BRAKE-AF project might allow inclusion of ivabradine within the limited arsenal of drugs currently available for rate control in AF. CLINICAL

trial registrationhttp://www.clinicaltrials.gov. Identifier: NCT03718273.

Indexed as

Anti-Arrhythmia AgentsAtrial FibrillationCardiovascular AgentsClinical Trials, Phase III as TopicDigoxinEquivalence Trials as TopicHeart RateHumansIvabradineMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeAnti-Arrhythmia AgentsCardiovascular AgentsDigoxinIvabradineAction potentialAtrioventricular nodeControl de frecuenciaDigoxinDigoxinaFibrilación auricular permanenteIvabradinaIvabradineNódulo auriculoventricularParche de membranaPatch clampPersistent atrial fibrillationPotencial de acciónRate control

Identifiers

PMID31631048
OpenAlexW2980795580

What OpenQuestion holds

Textmetadata
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.