Clinical trial NCT02548364: Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Keywords: Vitamin D
Myocardial Infarction
Ventricular remodeling
Biomarkers
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
name: Spanish Society of Cardiology
First posted: 2015-09-14
Enrollment: 109
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in cardiac remodeling by MRI
timeFrame: 1 year
Secondary outcomes:
measure: Change in echocardiographic parameters
timeFrame: 1year
measure: Change in mineral metabolism parameters
timeFrame: 1 year
measure: Change in prognostic biomarkers levels
timeFrame: 1 year
measure: Change in lipid levels
timeFrame: 1 year
measure: Change in flow mediated vasodilation
timeFrame: 1 year
measure: Adverse event rate
timeFrame: 1.5, 3, 6, 9, 12 and 13 months
measure: % of treatment compliance
timeFrame: 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Fuenlabrada
country: Spain
facility: Hospital de Fuenlabrada
state: Madrid
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: Mostoles
country: Spain
facility: Hospital Rey Juan Carlos
state: Madrid
city: Móstoles
country: Spain
facility: Hospital de Móstoles
state: Madrid
city: Valdemoro
country: Spain
facility: Hospital Infanta Elena
state: Madrid
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
Study officials:
affiliation: IIS-FJD
name: JOSE TUÑON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tunon J, Gonzalez-Hernandez I, Llanos-Jimenez L, Alonso-Martin J, Escudier-Villa JM, Tarin N, Cristobal C, Sanz P, Pello AM, Acena A, Carda R, Orejas M, Tomas M, Beltran P, Calero Rueda M, Marcos E, Serrano-Antolin JM, Gutierrez-Landaluce C, Jimenez R, Cabezudo J, Curcio A, Peces-Barba G, Gonzalez-Parra E, Munoz-Siscart R, Gonzalez-Casaus ML, Lorenzo A, Huelmos A, Goicolea J, Ibanez B, Hernandez G, Alonso-Pulpon LM, Farre J, Lorenzo O, Mahillo-Fernandez I, Egido J. Design and rationale of a multicentre, randomised, double-blind, placebo-controlled clinical trial to evaluate the effect of vitamin D on ventricular remodelling in patients with anterior myocardial infarction: the VITamin D in Acute Myocardial Infarction (VITDAMI) trial. BMJ Open. 2016 Aug 5;6(8):e011287. doi: 10.1136/bmjopen-2016-011287.