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
| Autor: | Raquel Muñoz-Siscart, Carlos Gutiérrez-Landaluce, Óscar Lorenzo, Miguel Orejas, Lucía Llanos-Jiménez, Jerónimo Farré, Gonzalo Hernández, Borja Ibanez, José Tuñón, Nieves Tarín, Joaquín Alonso-Martín, Emilio González-Parra, Marta Tomás, Ignacio González-Hernández, Esther Marcos, Petra Sanz, Rocío Carda, Ignacio Mahillo-Fernández, Jesús Egido, Paula Beltrán, Luis Alonso-Pulpón, Juan Manuel Escudier-Villa, María Luisa González-Casaus, Antonio Lorenzo, Ana Huelmos, Álvaro Aceña, Ana Maria Pello, Rosa Jimenez, Alejandro Curcio, Marta Calero Rueda, Javier Goicolea, Carmen Cristóbal, Germán Peces-Barba, José María Serrano-Antolín, Jorge Cabezudo |
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| Přispěvatelé: | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Instituto de Salud Carlos III, Sociedad Española de Cardiología |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
CHRONIC KIDNEY-DISEASE
Male 030204 cardiovascular system & hematology Cardiovascular Medicine chemistry.chemical_compound 0302 clinical medicine SERUM 25-HYDROXYVITAMIN-D Natriuretic Peptide Brain Protocol 030212 general & internal medicine Myocardial infarction Vitamin D Angioplasty Balloon Coronary Chemokine CCL2 remodeling RISK Aged 80 and over Ejection fraction Ventricular Remodeling Heart General Medicine Middle Aged Institutional review board Magnetic Resonance Imaging FIBROBLAST GROWTH FACTOR-23 Tolerability CARDIOVASCULAR-DISEASE Research Design Cardiology CORONARY-ARTERY-DISEASE Female Adult medicine.medical_specialty calcifediol PARATHYROID-HORMONE cardiac magnetic resonance imaging acute myocardial infarction ALL-CAUSE Placebo 03 medical and health sciences D DEFICIENCY Double-Blind Method Internal medicine Vitamin D and neurology medicine Humans cardiovascular diseases Aged business.industry MORTALITY medicine.disease Surgery Clinical trial Fibroblast Growth Factor-23 chemistry Spain ST Elevation Myocardial Infarction Calcifediol business Biomarkers |
| Zdroj: | BMJ Open Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid Consejería de Sanidad de la Comunidad de Madrid Repisalud Instituto de Salud Carlos III (ISCIII) |
| ISSN: | 2044-6055 |
| Popis: | 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. The VITDAMI trial is an investigator initiated study, sponsored by the Instituto de Investigacion Sanitaria Fundacion Jimenez Diaz (IIS-FJD). Funding has been obtained from Fondo de Investigaciones Sanitarias (PI14/01567; http://www.isciii.es/) and Spanish Society of Cardiology (http://secardiologia.es/). In addition, the study medication has been provided freely by the pharmaceutical Company FAES FARMA S.A. (Leioa, Vizcaya, Spain; http://faesfarma.com/). This company was the only funder who collaborated in study design (IG-H). Sí |
| Databáze: | OpenAIRE |
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