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

Myocardial Infarction Clinical Trial

— VITDAMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548364
• Other study ID #: FJD-VITDAMI-14-01
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: May 2023

Study information

• Verified date: October 2023
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Ventricular Remodeling

Intervention

Drug:
• Calcifediol
calcifediol treatment
• Placebo
placebo control group

Locations

Country	Name	City	State
Spain	Hospital de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital Universitario de Getafe	Getafe	Madrid
Spain	Fundación Jiménez Díaz	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

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	Fondo de Investigacion Sanitaria, Spanish Society of Cardiology

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in flow mediated vasodilation		1 year
Secondary	Adverse event rate		1.5, 3, 6, 9, 12 and 13 months
Secondary	% of treatment compliance		3, 6, 9 and 12 months