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| Name | Class |
|---|---|
| Fondo de Investigacion Sanitaria | OTHER |
| Spanish Society of Cardiology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcifediol | Experimental | One capsule with 15,690 IU p.o. every two weeks |
|
| Placebo | Placebo Comparator | One capsule with placebo p.o. every two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcifediol | Drug | calcifediol treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in mineral metabolism parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JOSE TUÑON, MD, PhD | IIS-FJD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Fuenlabrada | Fuenlabrada | Madrid | Spain | |||
| Hospital Universitario de Getafe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41942544 | Derived | Tunon J, Rodriguez-Lopez C, Balaguer J, Gomez-Talavera S, Rojas A, Salamanca J, Garcia CL, Esteve-Pastor MA, Laffond A, Herrera C, Escudier-Villa JM, Orejas M, Tomas M, Alvarez ML, Tomeo MA, Llanos-Jimenez L, Gonzalez-Lorenzo O, Kallmeyer A, Ibanez B, Gonzalez-Casaus ML, Hernandez G, Espadas C, Lorenzo O, Mahillo-Fernandez I, Egido J, Sanchez PL, Marin F, Alfonso F. Vitamin D in the prevention of left ventricular remodelling after an acute myocardial infarction: a randomized clinical trial. Sci Rep. 2026 Apr 6;16(1):16486. doi: 10.1038/s41598-026-45330-6. | |
| 27496232 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D020257 | Ventricular Remodeling |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D002112 | Calcifediol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
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| Placebo | Drug | placebo control group |
|
It is a composite outcome measure. It will be analyzed by measuring plasma levels of calcidiol, FGF-23, klotho, phosphate, and PTH |
| 1 year |
| 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 |
| 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 |
| Change in flow mediated vasodilation | 1 year |
| Adverse event rate | 1.5, 3, 6, 9, 12 and 13 months |
| % of treatment compliance | 3, 6, 9 and 12 months |
| Getafe |
| Madrid |
| 28905 |
| Spain |
| Hospital Puerta de Hierro | Majadahonda | Madrid | Spain |
| Hospital Rey Juan Carlos | Móstoles | Madrid | 28933 | Spain |
| Hospital de Móstoles | Móstoles | Madrid | Spain |
| Hospital Infanta Elena | Valdemoro | Madrid | 28342 | Spain |
| Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Derived |
| 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. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D020763 | Pathological Conditions, Anatomical |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |