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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02548364

Acronym

VITDAMI

Enrollment

109

Registered

2015-09-14

Start date

2015-10-31

Completion date

2023-05-31

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Vitamin D, Myocardial Infarction, Ventricular remodeling, Biomarkers

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.

Interventions

DRUGCalcifediol

calcifediol treatment

DRUGPlacebo

placebo control group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026