Mostrar el registro sencillo del ítem
dc.contributor.author | Tunon, Jose | |
dc.contributor.author | Gonzalez-Hernandez, Ignacio | |
dc.contributor.author | Llanos-Jimenez, Lucia | |
dc.contributor.author | Alonso-Martin, Joaquin | |
dc.contributor.author | Escudier-Villa, Juan M. | |
dc.contributor.author | Tarin, Nieves | |
dc.contributor.author | Cristobal, Carmen | |
dc.contributor.author | Sanz, Petra | |
dc.contributor.author | Pello, Ana M. | |
dc.contributor.author | Acena, Alvaro | |
dc.contributor.author | Carda, Rocio | |
dc.contributor.author | Orejas, Miguel | |
dc.contributor.author | Tomas, Marta | |
dc.contributor.author | Beltran, Paula | |
dc.contributor.author | Calero Rueda, Marta | |
dc.contributor.author | Marcos, Esther | |
dc.contributor.author | Maria Serrano-Antolin, Jose | |
dc.contributor.author | Gutierrez-Landaluce, Carlos | |
dc.contributor.author | Jimenez, Rosa | |
dc.contributor.author | Cabezudo, Jorge | |
dc.contributor.author | Curcio, Alejandro | |
dc.contributor.author | Peces-Barba, German | |
dc.contributor.author | Gonzalez-Parra, Emilio | |
dc.contributor.author | Munoz-Siscart, Raquel | |
dc.contributor.author | Luisa Gonzalez-Casaus, Maria | |
dc.contributor.author | Lorenzo, Antonio | |
dc.contributor.author | Huelmos, Ana | |
dc.contributor.author | Goicolea, Javier | |
dc.contributor.author | Ibáñez, Borja | |
dc.contributor.author | Hernandez, Gonzalo | |
dc.contributor.author | Alonso-Pulpon, Luis | |
dc.contributor.author | Farre, Jeronimo | |
dc.contributor.author | Lorenzo, Oscar | |
dc.contributor.author | Mahillo-Fernandez, Ignacio | |
dc.contributor.author | Egido, Jesus | |
dc.date.accessioned | 2017-10-30T13:32:27Z | |
dc.date.available | 2017-10-30T13:32:27Z | |
dc.date.issued | 2016 | |
dc.identifier | ISI:000382336700153 | |
dc.identifier.citation | BMJ Open. 2016; 6(8):e011287 | |
dc.identifier.issn | 2044-6055 | |
dc.identifier.uri | http://hdl.handle.net/20.500.12105/5247 | |
dc.description.abstract | Introduction: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.sponsorship | The 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; http://www.isciii.es/) and Spanish Society of Cardiology (http://secardiologia.es/). In addition, the study medication has been provided freely by the pharmaceutical Company FAES FARMA S.A. (Leioa, Vizcaya, Spain; http://faesfarma.com/). This company was the only funder who collaborated in study design (IG-H). | |
dc.language.iso | eng | |
dc.publisher | BMJ Publishing Group | |
dc.type.hasVersion | VoR | |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/4.0/ | * |
dc.subject | CORONARY-ARTERY-DISEASE | |
dc.subject | CHRONIC KIDNEY-DISEASE | |
dc.subject | FIBROBLAST GROWTH FACTOR-23 | |
dc.subject | CARDIOVASCULAR-DISEASE | |
dc.subject | PARATHYROID-HORMONE | |
dc.subject | D DEFICIENCY | |
dc.subject | SERUM 25-HYDROXYVITAMIN-D | |
dc.subject | ALL-CAUSE | |
dc.subject | RISK | |
dc.subject | MORTALITY | |
dc.title | 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 | |
dc.type | journal article | |
dc.rights.license | Atribución-NoComercial 4.0 Internacional | * |
dc.identifier.pubmedID | 27496232 | |
dc.format.volume | 6 | |
dc.identifier.doi | 10.1136/bmjopen-2016-011287 | |
dc.contributor.funder | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | |
dc.contributor.funder | Instituto de Salud Carlos III | |
dc.contributor.funder | Sociedad Española de Cardiología | |
dc.description.peerreviewed | Sí | |
dc.relation.publisherversion | https://doi.org/10.1136/bmjopen-2016-011287 | |
dc.identifier.journal | BMJ Open | |
dc.repisalud.orgCNIC | CNIC::Grupos de investigación::Laboratorio Traslacional para la Imagen y Terapia Cardiovascular | |
dc.repisalud.institucion | CNIC | |
dc.rights.accessRights | open access | es_ES |