Tuñón José, González-Hernández Ignacio, Llanos-Jiménez Lucía, Alonso-Martín Joaquín, Escudier-Villa Juan M, Tarín Nieves, Cristóbal Carmen, Sanz Petra, Pello Ana M, Aceña Álvaro, Carda Rocío, Orejas Miguel, Tomás Marta, Beltrán Paula, Calero Rueda Marta, Marcos Esther, Serrano-Antolín José María, Gutiérrez-Landaluce Carlos, Jiménez Rosa, Cabezudo Jorge, Curcio Alejandro, Peces-Barba Germán, González-Parra Emilio, Muñoz-Siscart Raquel, González-Casaus María Luisa, Lorenzo Antonio, Huelmos Ana, Goicolea Javier, Ibáñez Borja, Hernández Gonzalo, Alonso-Pulpón Luis M, Farré Jerónimo, Lorenzo Óscar, Mahíllo-Fernández Ignacio, Egido Jesús
Department of Cardiology, Fundación Jiménez Díaz, Madrid, Spain Department of Medicine, Autónoma University, Madrid, Spain Vascular Research Laboratory, IIS-Fundación Jiménez Díaz, Madrid, Spain.
Department of Cardiology, Fundación Jiménez Díaz, Madrid, Spain.
BMJ Open. 2016 Aug 5;6(8):e011287. doi: 10.1136/bmjopen-2016-011287.
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.
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.
to evaluate the effect of calcifediol on LV remodelling defined as an increase in LV end-diastolic volume ≥10% (MRI).
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.
This trial has been approved by the corresponding Institutional Review Board (IRB) and National Competent Authority (Agencia Española 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.
NCT02548364; Pre-results.
血浆维生素D（VD）水平降低与心血管损伤有关。然而，临床试验尚未证明补充VD对左心室（LV）重构有益。前壁ST段抬高型急性心肌梗死（STEMI）是研究治疗对LV重构影响的最佳人体模型。我们开展了一项概念验证研究，旨在调查VD是否能改善前壁STEMI患者的LV重构。
急性心肌梗死维生素D（VITDAMI）试验是一项多中心、随机、双盲、安慰剂对照试验。144例前壁STEMI患者将按2:1的比例被分配接受骨化二醇0.266 mg胶囊（Hidroferol SGC）/15天或安慰剂治疗，为期12个月。
评估骨化二醇对LV重构的影响，定义为LV舒张末期容积增加≥10%（磁共振成像）。
LV舒张末期和收缩末期容积、射血分数、LV质量、舒张功能、球形指数和纤维化面积大小的变化；内皮功能；B型利钠肽氨基末端片段、半乳糖凝集素-3和单核细胞趋化蛋白-1的血浆水平；骨化二醇（VD代谢产物）水平及矿物质代谢的其他成分（成纤维细胞生长因子-23（FGF-23）、其受体klotho的可溶性形式、甲状旁腺激素和磷酸盐）。将根据FGF-23和klotho的血浆水平研究VD作用的差异。评估治疗的安全性和耐受性。这是第一项评估VD对STEMI患者心脏重构影响的研究。
本试验已获得相应的机构审查委员会（IRB）和国家主管当局（西班牙药品和卫生产品管理局（AEMPS））的批准。将按照良好临床实践（人用药品技术要求国际协调理事会 - 良好临床实践（ICH-GCP））要求、《赫尔辛基宣言》的伦理原则和国家法律进行。研究结果将提交给索引医学期刊以及国内和国际会议。
NCT02548364；预结果。
