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

Phase 3

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: Placebo; Drug: Calcifediol

• Registration Number: NCT02548364
• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-14
• Study Start: 2015-10
• Primary Completion: 2023-05
• Study Completion: 2023-05
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	One capsule with placebo p.o. every two weeks
Calcifediol	Calcifediol	One capsule with 15,690 IU p.o. every two weeks

Primary Outcome Measures

Name	Time	Method
Change in cardiac remodeling by MRI	1 year	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

Secondary Outcome Measures

Name	Time	Method
Change in echocardiographic parameters	1year	It is a composite outcome measure. It will be analyzed by measuring the following parameters: ventricular thickness and diameters, contractility abnormalities, ejection fraction.
Change in mineral metabolism parameters	1 year	It is a composite outcome measure. It will be analyzed by measuring plasma levels of calcidiol, FGF-23, klotho, phosphate, and PTH
Change in prognostic biomarkers levels	1 year	It is a composite outcome measure. It will be analyzed by measuring plasma levels of NT-proBNP, hsCRP, MCP-1 and galectin-3
Change in lipid levels	1 year	It is a composite outcome measure. It will be analyzed by measuring plasma levels of TC, LDL, HDL, TG and non-HDL Cholesterol
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

Trial Locations

Locations (7)

Hospital de Fuenlabrada; 🇪🇸 Fuenlabrada, Madrid, Spain

Hospital Universitario de Getafe; 🇪🇸 Getafe, Madrid, Spain

Hospital Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Rey Juan Carlos; 🇪🇸 Mostoles, Madrid, Spain

Hospital de Móstoles; 🇪🇸 Móstoles, Madrid, Spain

Hospital Infanta Elena; 🇪🇸 Valdemoro, Madrid, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain