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oai:repisalud.isciii.es:20.500.12105/52472024-09-27T09:56:35Zcom_20.500.12105_19604com_20.500.12105_2051col_20.500.12105_19605
Repisalud author Tunon, Jose author Gonzalez-Hernandez, Ignacio author Llanos-Jimenez, Lucia author Alonso-Martin, Joaquin author Escudier-Villa, Juan M. author Tarin, Nieves author Cristobal, Carmen author Sanz, Petra author Pello, Ana M. author Acena, Alvaro author Carda, Rocio author Orejas, Miguel author Tomas, Marta author Beltran, Paula author Calero Rueda, Marta author Marcos, Esther author Maria Serrano-Antolin, Jose author Gutierrez-Landaluce, Carlos author Jimenez, Rosa author Cabezudo, Jorge author Curcio, Alejandro author Peces-Barba, German author Gonzalez-Parra, Emilio author Munoz-Siscart, Raquel author Luisa Gonzalez-Casaus, Maria author Lorenzo, Antonio author Huelmos, Ana author Goicolea, Javier author Ibáñez, Borja author Hernandez, Gonzalo author Alonso-Pulpon, Luis author Farre, Jeronimo author Lorenzo, Oscar author Mahillo-Fernandez, Ignacio author Egido, Jesus funder Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz funder Instituto de Salud Carlos III funder Sociedad Española de Cardiología 2017-10-30T13:32:27Z 2017-10-30T13:32:27Z 2016 BMJ Open. 2016; 6(8):e011287 2044-6055 http://hdl.handle.net/20.500.12105/5247 27496232 10.1136/bmjopen-2016-011287 BMJ Open 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. eng CORONARY-ARTERY-DISEASE CHRONIC KIDNEY-DISEASE FIBROBLAST GROWTH FACTOR-23 CARDIOVASCULAR-DISEASE PARATHYROID-HORMONE D DEFICIENCY SERUM 25-HYDROXYVITAMIN-D ALL-CAUSE RISK MORTALITY 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 journal article URL https://repisalud.isciii.es/bitstreams/b2c24381-0c92-4f1c-973d-40f4688a79a5/download File MD5 22a1bcdde3e37fd2edfe1f7ba6dbd036 1250724 application/pdf DesignAndRationaleOf_2016 URL https://repisalud.isciii.es/bitstreams/05faff6b-404b-484d-8d72-907225b836ce/download File MD5 eea55b96dfd77988bdc824e889da9fe4 58198 text/plain DesignAndRationaleOf_2016.txt