Show simple item record

dc.contributor.authorTunon, Jose
dc.contributor.authorGonzalez-Hernandez, Ignacio
dc.contributor.authorLlanos-Jimenez, Lucia
dc.contributor.authorAlonso-Martin, Joaquin
dc.contributor.authorEscudier-Villa, Juan M.
dc.contributor.authorTarin, Nieves
dc.contributor.authorCristobal, Carmen
dc.contributor.authorSanz, Petra
dc.contributor.authorPello, Ana M.
dc.contributor.authorAcena, Alvaro
dc.contributor.authorCarda, Rocio
dc.contributor.authorOrejas, Miguel
dc.contributor.authorTomas, Marta
dc.contributor.authorBeltran, Paula
dc.contributor.authorCalero Rueda, Marta
dc.contributor.authorMarcos, Esther
dc.contributor.authorMaria Serrano-Antolin, Jose
dc.contributor.authorGutierrez-Landaluce, Carlos
dc.contributor.authorJimenez, Rosa
dc.contributor.authorCabezudo, Jorge
dc.contributor.authorCurcio, Alejandro
dc.contributor.authorPeces-Barba, German
dc.contributor.authorGonzalez-Parra, Emilio
dc.contributor.authorMunoz-Siscart, Raquel
dc.contributor.authorLuisa Gonzalez-Casaus, Maria
dc.contributor.authorLorenzo, Antonio
dc.contributor.authorHuelmos, Ana
dc.contributor.authorGoicolea, Javier
dc.contributor.authorIbanez, Borja 
dc.contributor.authorHernandez, Gonzalo
dc.contributor.authorAlonso-Pulpon, Luis
dc.contributor.authorFarre, Jeronimo
dc.contributor.authorLorenzo, Oscar
dc.contributor.authorMahillo-Fernandez, Ignacio 
dc.contributor.authorEgido, Jesus
dc.identifier.citationBMJ Open. 2016; 6(8):e011287
dc.description.abstractIntroduction:Decreased 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 objective:to evaluate the effect of calcifediol on LV remodelling defined as an increase in LV end-diastolic volume >= 10\% (MRI). Secondary objectives:change 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 Espanola 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.
dc.description.sponsorshipThe VITDAMI trial is an investigator initiated study, sponsored by the Instituto de Investigacion Sanitaria Fundacion Jimenez Diaz (IIS-FJD). Funding has been obtained from Fondo de Investigaciones Sanitarias (PI14/01567; and Spanish Society of Cardiology ( In addition, the study medication has been provided freely by the pharmaceutical Company FAES FARMA S.A. (Leioa, Vizcaya, Spain; This company was the only funder who collaborated in study design (IG-H).
dc.publisherBMJ Publishing Group 
dc.relation.isversionofPublisher's version
dc.subjectD DEFICIENCY
dc.titleDesign 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
dc.rights.licenseAtribución-NoComercial 4.0 Internacional*
dc.contributor.funderInstituto de Investigacion Sanitaria Fundacion Jimenez Diaz
dc.contributor.funderInstituto de Salud Carlos III - ISCIII
dc.contributor.funderSociedad Española de Cardiología
dc.identifier.journalBMJ Open
dc.repisalud.orgCNICCNIC::Grupos de investigación::Laboratorio Traslacional para la Imagen y Terapia Cardiovascular

Files in this item

Acceso Abierto

This item appears in the following Collection(s)

Show simple item record

Atribución-NoComercial 4.0 Internacional
This item is licensed under a: Atribución-NoComercial 4.0 Internacional