title: 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.
abstract: 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.
authors: Department of Cardiology, Fundación Jiménez Díaz, Madrid, Spain Department of Medicine, Autónoma University, Madrid, Spain Vascular Research Laboratory, IIS-Fundación Jiménez Díaz, Madrid, Spain.
authors: José
authors: J
authors: Tuñón
authors: Department of Cardiology, Fundación Jiménez Díaz, Madrid, Spain.
authors: Ignacio
authors: I
authors: González-Hernández
authors: Research Unit, IIS-Fundación Jiménez Díaz, Madrid, Spain.
authors: Lucía
authors: L
authors: Llanos-Jiménez
authors: Department of Cardiology, University Hospital of Getafe, Madrid, Spain Department of Medicine, Rey Juan Carlos University, Alcorcón, Spain.
authors: Joaquín
authors: J
authors: Alonso-Martín
authors: Department of Cardiology, University Hospital Puerta de Hierro, Madrid, Spain.
authors: Juan M
authors: JM
authors: Escudier-Villa
authors: Department of Cardiology, University Hospital of Móstoles, Móstoles, Spain.
authors: Nieves
authors: N
authors: Tarín
authors: Department of Medicine, Rey Juan Carlos University, Alcorcón, Spain Department of Cardiology, Hospital de Fuenlabrada, Madrid, Spain.
authors: Carmen
authors: C
authors: Cristóbal
authors: Department of Medicine, Rey Juan Carlos University, Alcorcón, Spain Department of Cardiology, Hospital Rey Juan Carlos, Madrid, Spain.
authors: Petra
authors: P
authors: Sanz
authors: Department of Cardiology, Fundación Jiménez Díaz, Madrid, Spain.
authors: Ana M
authors: AM
authors: Pello
authors: Department of Cardiology, Fundación Jiménez Díaz, Madrid, Spain.
authors: Álvaro
authors: Á
authors: Aceña
authors: Department of Cardiology, Fundación Jiménez Díaz, Madrid, Spain.
authors: Rocío
authors: R
authors: Carda
authors: Department of Cardiology, Fundación Jiménez Díaz, Madrid, Spain.
authors: Miguel
authors: M
authors: Orejas
authors: Department of Radiology, Fundación Jiménez Díaz, Madrid, Spain.
authors: Marta
authors: M
authors: Tomás
authors: Department of Cardiology, Fundación Jiménez Díaz, Madrid, Spain.
authors: Paula
authors: P
authors: Beltrán
authors: Department of Cardiology, Hospital Rey Juan Carlos, Madrid, Spain.
authors: Marta
authors: M
authors: Calero Rueda
authors: Department of Cardiology, University Hospital of Móstoles, Móstoles, Spain.
authors: Esther
authors: E
authors: Marcos
authors: Department of Cardiology, Hospital de Fuenlabrada, Madrid, Spain.
authors: José María
authors: JM
authors: Serrano-Antolín
authors: Department of Cardiology, Hospital de Fuenlabrada, Madrid, Spain.
authors: Carlos
authors: C
authors: Gutiérrez-Landaluce
authors: Department of Cardiology, Hospital de Fuenlabrada, Madrid, Spain.
authors: Rosa
authors: R
authors: Jiménez
authors: Department of Cardiology, Hospital de Fuenlabrada, Madrid, Spain.
authors: Jorge
authors: J
authors: Cabezudo
authors: Department of Cardiology, Hospital de Fuenlabrada, Madrid, Spain.
authors: Alejandro
authors: A
authors: Curcio
authors: Department of Medicine, Autónoma University, Madrid, Spain Department of Pneumology, Fundación Jiménez Díaz, Madrid, Spain.
authors: Germán
authors: G
authors: Peces-Barba
authors: Department of Medicine, Autónoma University, Madrid, Spain Department of Nephrology, Fundación Jiménez Díaz, Madrid, Spain.
authors: Emilio
authors: E
authors: González-Parra
authors: Research Unit, IIS-Fundación Jiménez Díaz, Madrid, Spain.
authors: Raquel
authors: R
authors: Muñoz-Siscart
authors: Laboratory of Renal Function, Hospital Gómez-Ulla, Madrid, Spain.
authors: María Luisa
authors: ML
authors: González-Casaus
authors: Department of Cardiology, University Hospital of Móstoles, Móstoles, Spain.
authors: Antonio
authors: A
authors: Lorenzo
authors: Department of Cardiology, Fundación Hospital Alcorcón, Madrid, Spain.
authors: Ana
authors: A
authors: Huelmos
authors: Department of Cardiology, University Hospital Puerta de Hierro, Madrid, Spain.
authors: Javier
authors: J
authors: Goicolea
authors: Department of Cardiology, Fundación Jiménez Díaz, Madrid, Spain Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.
authors: Borja
authors: B
authors: Ibáñez
authors: FAES FARMA S.A. Laboratories, Vizcaya, Spain.
authors: Gonzalo
authors: G
authors: Hernández
authors: Department of Medicine, Autónoma University, Madrid, Spain Department of Cardiology, University Hospital Puerta de Hierro, Madrid, Spain.
authors: Luis M
authors: LM
authors: Alonso-Pulpón
authors: Department of Cardiology, Fundación Jiménez Díaz, Madrid, Spain Department of Medicine, Autónoma University, Madrid, Spain.
authors: Jerónimo
authors: J
authors: Farré
authors: Department of Medicine, Autónoma University, Madrid, Spain Vascular Research Laboratory, IIS-Fundación Jiménez Díaz, Madrid, Spain.
authors: Óscar
authors: Ó
authors: Lorenzo
authors: Research Unit, IIS-Fundación Jiménez Díaz, Madrid, Spain.
authors: Ignacio
authors: I
authors: Mahíllo-Fernández
authors: Department of Medicine, Autónoma University, Madrid, Spain Vascular Research Laboratory, IIS-Fundación Jiménez Díaz, Madrid, Spain Department of Nephrology, Fundación Jiménez Díaz, Madrid, Spain CIBERDEM, Madrid, Spain.
authors: Jesús
authors: J
authors: Egido
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D015415:Biomarkers / Q000097:blood*; D002112:Calcifediol / Q000008:administration & dosage* / Q000097:blood*; D018932:Chemokine CCL2 / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D000089703:Fibroblast Growth Factor-23; D006321:Heart / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000097:blood; D012107:Research Design; D000072657:ST Elevation Myocardial Infarction / Q000628:therapy*; D013030:Spain; D020257:Ventricular Remodeling / Q000187:drug effects*
chemical_list: D015415:Biomarkers; D018932:Chemokine CCL2; C000717427:FGF23 protein, human; D020097:Natriuretic Peptide, Brain; D000089703:Fibroblast Growth Factor-23; D002112:Calcifediol
keywords: Vitamin D; acute myocardial infarction; calcifediol; cardiac magnetic resonance imaging; remodeling