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

Last updated: October 2, 2023
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Overall Status: Completed

Phase

3

Condition

Blood Clots

Coronary Artery Disease

Angina

Treatment

Calcifediol

Placebo

Clinical Study ID

NCT02548364
FJD-VITDAMI-14-01
  • Ages 40-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 40 years and maximum 85 years.
  • Anterior myocardial infarction
  • Sign informed consent

Exclusion

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

Total Participants: 109
Treatment Group(s): 2
Primary Treatment: Calcifediol
Phase: 3
Study Start date:
October 01, 2015
Estimated Completion Date:
May 31, 2023

Connect with a study center

  • Hospital de Fuenlabrada

    Fuenlabrada, Madrid
    Spain

    Site Not Available

  • Hospital Universitario de Getafe

    Getafe, Madrid 28905
    Spain

    Site Not Available

  • Hospital Puerta de Hierro

    Majadahonda, Madrid
    Spain

    Site Not Available

  • Hospital Rey Juan Carlos

    Mostoles, Madrid 28933
    Spain

    Site Not Available

  • Hospital de Móstoles

    Móstoles, Madrid
    Spain

    Site Not Available

  • Hospital Infanta Elena

    Valdemoro, Madrid 28342
    Spain

    Site Not Available

  • Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

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