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

• Published in: BMJ open 2016-08, Vol.6 (8), p.e011287-e011287
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Biomarkers - blood; Calcifediol - administration & dosage; Calcifediol - blood; Calcification; Cardiovascular disease; Cardiovascular Medicine; Chemokine CCL2 - blood; Clinical trials; Coronary vessels; Double-Blind Method; Ejection fraction; Female; Fibroblasts; Growth factors; Heart - diagnostic imaging; Heart - physiopathology; Heart attacks; Humans; Hypertension; Hypotheses; Inflammation; Kidney diseases; Magnetic Resonance Imaging; Male; Metabolism; Middle Aged; Mortality; Natriuretic Peptide, Brain - blood; Plasma; Proteins; Research Design; Spain; ST Elevation Myocardial Infarction - therapy; Vein & artery diseases; Ventricular Remodeling - drug effects; Vitamin D
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2016-011287

IntroductionDecreased 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 analysisThe 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 disseminationThis 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.Trial registration numberNCT02548364; Pre-results.