Evidence map›Paper›PMID 27496232›Full record

Trial reportBMJ open2016

Design and rationale of a multicentre, randomised, double-blind, placebo-controlled clinical trial to evaluate the effect of vitamin D on ventricular remodelling in patients with anterior myocardial infarction: the VITamin D in Acute Myocardial Infarction (VITDAMI) trial.

José Tuñón, Ignacio González-Hernández, Lucía Llanos-Jiménez, Joaquín Alonso-Martín, Juan M Escudier-Villa, Nieves Tarín, Carmen Cristóbal, Petra Sanz, Ana M Pello, Álvaro Aceña and 25 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02548364 (Multicentric, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction), 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
0.7field-weighted citation impact, top 27% 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.

NCT02548364 phase3completednot on this map

Multicentric, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction

TypeinterventionalSponsorInstituto de Investigación Sanitaria de la Fundación Jiménez DíazRan2015 to 2023Enrolled109ConditionsMyocardial InfarctionArmsCalcifediol, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Review
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

35 authors at 10 institutions in 1 country.

José TuñónDepartment of Cardiology, Fundación Jiménez Díaz, Madrid, Spain Department of Medicine, Autónoma University, Madrid, Spain Vascular Research Laboratory, IIS-Fundación Jiménez Díaz, Madrid, Spain.
Ignacio González-HernándezDepartment of Cardiology, Fundación Jiménez Díaz, Madrid, Spain.
Lucía Llanos-JiménezResearch Unit, IIS-Fundación Jiménez Díaz, Madrid, Spain.
Joaquín Alonso-MartínDepartment of Cardiology, University Hospital of Getafe, Madrid, Spain Department of Medicine, Rey Juan Carlos University, Alcorcón, Spain.
Juan M Escudier-VillaDepartment of Cardiology, University Hospital Puerta de Hierro, Madrid, Spain.
Nieves TarínDepartment of Cardiology, University Hospital of Móstoles, Móstoles, Spain.
Carmen CristóbalDepartment of Medicine, Rey Juan Carlos University, Alcorcón, Spain Department of Cardiology, Hospital de Fuenlabrada, Madrid, Spain.
Petra SanzDepartment of Medicine, Rey Juan Carlos University, Alcorcón, Spain Department of Cardiology, Hospital Rey Juan Carlos, Madrid, Spain.
Ana M PelloDepartment of Cardiology, Fundación Jiménez Díaz, Madrid, Spain.
Álvaro AceñaDepartment of Cardiology, Fundación Jiménez Díaz, Madrid, Spain.
Rocío CardaDepartment of Cardiology, Fundación Jiménez Díaz, Madrid, Spain.
Miguel OrejasDepartment of Cardiology, Fundación Jiménez Díaz, Madrid, Spain.
Marta TomásDepartment of Radiology, Fundación Jiménez Díaz, Madrid, Spain.
Paula BeltránDepartment of Cardiology, Fundación Jiménez Díaz, Madrid, Spain.
Marta Calero RuedaDepartment of Cardiology, Hospital Rey Juan Carlos, Madrid, Spain.
Esther MarcosDepartment of Cardiology, University Hospital of Móstoles, Móstoles, Spain.
José María Serrano-AntolínDepartment of Cardiology, Hospital de Fuenlabrada, Madrid, Spain.
Carlos Gutiérrez-LandaluceDepartment of Cardiology, Hospital de Fuenlabrada, Madrid, Spain.
Rosa JiménezDepartment of Cardiology, Hospital de Fuenlabrada, Madrid, Spain.
Jorge CabezudoDepartment of Cardiology, Hospital de Fuenlabrada, Madrid, Spain.
Alejandro CurcioDepartment of Cardiology, Hospital de Fuenlabrada, Madrid, Spain.
Germán Peces-BarbaDepartment of Medicine, Autónoma University, Madrid, Spain Department of Pneumology, Fundación Jiménez Díaz, Madrid, Spain.
Emilio González-ParraDepartment of Medicine, Autónoma University, Madrid, Spain Department of Nephrology, Fundación Jiménez Díaz, Madrid, Spain.
Raquel Muñoz-SiscartResearch Unit, IIS-Fundación Jiménez Díaz, Madrid, Spain.
María Luisa González-CasausLaboratory of Renal Function, Hospital Gómez-Ulla, Madrid, Spain.
Antonio LorenzoDepartment of Cardiology, University Hospital of Móstoles, Móstoles, Spain.
Ana HuelmosDepartment of Cardiology, Fundación Hospital Alcorcón, Madrid, Spain.
Javier GoicoleaDepartment of Cardiology, University Hospital Puerta de Hierro, Madrid, Spain.
Borja IbáñezDepartment of Cardiology, Fundación Jiménez Díaz, Madrid, Spain Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.
Gonzalo HernándezFAES FARMA S.A. Laboratories, Vizcaya, Spain.
Luis M Alonso-PulpónDepartment of Medicine, Autónoma University, Madrid, Spain Department of Cardiology, University Hospital Puerta de Hierro, Madrid, Spain.
Jerónimo FarréDepartment of Cardiology, Fundación Jiménez Díaz, Madrid, Spain Department of Medicine, Autónoma University, Madrid, Spain.
Óscar LorenzoDepartment of Medicine, Autónoma University, Madrid, Spain Vascular Research Laboratory, IIS-Fundación Jiménez Díaz, Madrid, Spain.
Ignacio Mahíllo-FernándezResearch Unit, IIS-Fundación Jiménez Díaz, Madrid, Spain.
Jesús EgidoDepartment of Medicine, Autónoma University, Madrid, Spain Vascular Research Laboratory, IIS-Fundación Jiménez Díaz, Madrid, Spain Department of Nephrology, Fundación Jiménez Díaz, Madrid, Spain CIBERDEM, Madrid, Spain.
Hospital Universitario Fundación Jiménez Díaz · ESHospital Universitario de Fuenlabrada · ESHospital Universitario de Móstoles · ESHospital Universitario Puerta de Hierro Majadahonda · ESHospital Universitario Rey Juan Carlos · ESFaes Farma (Spain) · ESHospital Central de la Defensa Gómez Ulla · ESHospital Universitario Fundación Alcorcón · ESUniversidad Autónoma de Madrid · ESUniversidad Rey Juan Carlos · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDecreased plasma vitamin D (VD) levels are linked to cardiovascular damage. However, clinical trials have not demonstrated a benefit of VD supplements on left ventricular (LV) remodelling. Anterior ST-elevation acute myocardial infarction (STEMI) is the best human model to study the effect of treatments on LV remodelling. We present a proof-of-concept study that aims to investigate whether VD improves LV remodelling in patients with anterior STEMI. METHODS AND ANALYSIS: The VITamin D in Acute Myocardial Infarction (VITDAMI) trial is a multicentre, randomised, double-blind, placebo-controlled trial. 144 patients with anterior STEMI will be assigned to receive calcifediol 0.266 mg capsules (Hidroferol SGC)/15 days or placebo on a 2:1 basis during 12 months. PRIMARY

objectiveto evaluate the effect of calcifediol on LV remodelling defined as an increase in LV end-diastolic volume ≥10% (MRI). SECONDARY

objectiveschange in LV end-diastolic and end-systolic volumes, ejection fraction, LV mass, diastolic function, sphericity index and size of fibrotic area; endothelial function; plasma levels of aminoterminal fragment of B-type natriuretic peptide, galectin-3 and monocyte chemoattractant protein-1; levels of calcidiol (VD metabolite) and other components of mineral metabolism (fibroblast growth factor-23 (FGF-23), the soluble form of its receptor klotho, parathormone and phosphate). Differences in the effect of VD will be investigated according to the plasma levels of FGF-23 and klotho. Treatment safety and tolerability will be assessed. This is the first study to evaluate the effect of VD on cardiac remodelling in patients with STEMI. ETHICS AND DISSEMINATION: This trial has been approved by the corresponding Institutional Review Board (IRB) and National Competent Authority (Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)). It will be conducted in accordance with good clinical practice (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP)) requirements, ethical principles of the Declaration of Helsinki and national laws. The results will be submitted to indexed medical journals and national and international meetings. TRIAL REGISTRATION NUMBER: NCT02548364; Pre-results.

Indexed as

AdultAgedAged, 80 and overAngioplasty, Balloon, CoronaryBiomarkersCalcifediolChemokine CCL2Double-Blind MethodFemaleFibroblast Growth Factor-23HeartHumansMagnetic Resonance ImagingMaleMiddle AgedNatriuretic Peptide, BrainBiomarkersCalcifediolChemokine CCL2FGF23 protein, humanFibroblast Growth Factor-23Natriuretic Peptide, Brainacute myocardial infarctioncalcifediolcardiac magnetic resonance imagingremodelingVitamin D

Identifiers

PMID27496232
PMCPMC4985833
OpenAlexW2491353832

What OpenQuestion holds

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LicenceCC BY-NC
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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.