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

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction

Treatments: Drug: Calcifediol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02548364

FJD-VITDAMI-14-01

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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109 participants in 2 patient groups, including a placebo group

Calcifediol

Experimental group

Description:

One capsule with 15,690 IU p.o. every two weeks

Treatment:

Drug: Calcifediol

Placebo

Placebo Comparator group

Description:

One capsule with placebo p.o. every two weeks

Treatment:

Drug: Placebo