To study the effect of calcifediol on left ventricular remodeling, mineral metabolism, plasma levels of several prognostic biomarkers and on endothelial function after an anterior myocardial infarction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
109
calcifediol treatment
placebo control group
Hospital de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Rey Juan Carlos
Móstoles, Madrid, Spain
Change in cardiac remodeling by MRI
It is a composite outcome measure. It will be analyzed by measuring the following parameters: myocardium at risk, size of infarcted myocardium, saved myocardium, ejection fraction, left ventricular telesystolic and telediastolic volumes
Time frame: 1 year
Change in echocardiographic parameters
It is a composite outcome measure. It will be analyzed by measuring the following parameters: ventricular thickness and diameters, contractility abnormalities, ejection fraction.
Time frame: 1year
Change in mineral metabolism parameters
It is a composite outcome measure. It will be analyzed by measuring plasma levels of calcidiol, FGF-23, klotho, phosphate, and PTH
Time frame: 1 year
Change in prognostic biomarkers levels
It is a composite outcome measure. It will be analyzed by measuring plasma levels of NT-proBNP, hsCRP, MCP-1 and galectin-3
Time frame: 1 year
Change in lipid levels
It is a composite outcome measure. It will be analyzed by measuring plasma levels of TC, LDL, HDL, TG and non-HDL Cholesterol
Time frame: 1 year
Change in flow mediated vasodilation
Time frame: 1 year
Adverse event rate
Time frame: 1.5, 3, 6, 9, 12 and 13 months
% of treatment compliance
Time frame: 3, 6, 9 and 12 months
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Hospital de Móstoles
Móstoles, Madrid, Spain
Hospital Infanta Elena
Valdemoro, Madrid, Spain
Fundación Jiménez Díaz
Madrid, Spain