2024-03-29T01:36:02Zhttp://repisalud.isciii.es/oai/requestoai:repisalud.isciii.es:20.500.12105/52472023-12-15T09:09:48Zcom_20.500.12105_2145com_20.500.12105_2051com_20.500.12105_2144col_20.500.12105_2146
00925njm 22002777a 4500
dc
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
author
2016
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.
BMJ Open. 2016; 6(8):e011287
2044-6055
http://hdl.handle.net/20.500.12105/5247
27496232
10.1136/bmjopen-2016-011287
BMJ Open
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