Please use this identifier to cite or link to this item:http://hdl.handle.net/20.500.12105/5247
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
Tunon, Jose | Gonzalez-Hernandez, Ignacio | Llanos-Jimenez, Lucia | Alonso-Martin, Joaquin | Escudier-Villa, Juan M. | Tarin, Nieves | Cristobal, Carmen | Sanz, Petra | Pello, Ana M. | Acena, Alvaro | Carda, Rocio | Orejas, Miguel | Tomas, Marta | Beltran, Paula | Calero Rueda, Marta | Marcos, Esther | Maria Serrano-Antolin, Jose | Gutierrez-Landaluce, Carlos | Jimenez, Rosa | Cabezudo, Jorge | Curcio, Alejandro | Peces-Barba, German | Gonzalez-Parra, Emilio | Munoz-Siscart, Raquel | Luisa Gonzalez-Casaus, Maria | Lorenzo, Antonio | Huelmos, Ana | Goicolea, Javier | Ibanez, Borja CNIC | Hernandez, Gonzalo | Alonso-Pulpon, Luis M. | Farre, Jeronimo | Lorenzo, Oscar | Mahillo-Fernandez, Ignacio ISCIII | Egido, Jesus
BMJ Open. 2016; 6(8):e011287
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.
CORONARY-ARTERY-DISEASE | CHRONIC KIDNEY-DISEASE | FIBROBLAST GROWTH FACTOR-23 | CARDIOVASCULAR-DISEASE | PARATHYROID-HORMONE | D DEFICIENCY | SERUM 25-HYDROXYVITAMIN-D | ALL-CAUSE | RISK | MORTALITY
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