Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction (VITDAMI)

Study Overview
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Brief Summary
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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.

Official Title
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Multicentric, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Calcifediol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 40 years and maximum 85 years. Anterior myocardial infarction Sign informed consent Exclusion Criteria: Death during the index event Age younger than 40 or older than 85 years Previous Infarction More than 7 days in hospitalization Systemic inflammatory or autoimmune disease Concomitant disorders limiting survival Concomitant cardiomyopathy Left ventricular hypertrophy > 16mm in females and > 17mm in males eGFR<45 LVEF<30 Incomplete revascularization Valvular prosthesis Aortic stenosis with mean gradient> 25 mmHg Moderate or severe valvular regurgitation Hypersensitivity or intolerance vitamin D supplement o excipient Blood Calcium >10.5 mg/dl Inability to follow. Difficulty in treatment compliance Contraindication for MRI, including indication to place a cardiac device Indication of therapy with vitamin D. Patient desires to take vitamin D. Drugs or conditions that interfere with the pharmacokinetics of calcifediol

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcifediol<br>One capsule with 15,690 IU p.o. every two weeks | Drug: Calcifediol<br>* calcifediol treatment<br>* Other names: vitamin D;|
| Placebo Comparator: Placebo<br>One capsule with placebo p.o. every two weeks | Drug: Placebo<br>* placebo control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 1 year | 
| Change in flow mediated vasodilation |  | 1 year | 
| Adverse event rate |  | 1.5, 3, 6, 9, 12 and 13 months | 
| % of treatment compliance |  | 3, 6, 9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Myocardial Infarction, Ventricular remodeling, Biomarkers