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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Collaborators: Fondo de Investigacion Sanitaria; Spanish Society of Cardiology
• Treatments: Calcifediol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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