drugset / Trial / NCT02548364
Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction (VITDAMI)
Phase 3
Completed
109 enrolled
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Fondo de Investigacion Sanitaria · collabSpanish Society of Cardiology · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2015-10
- Primary completion
- 2023-05
- Completion
- 2023-05
Outcome
Missed primary endpoint
paper No differences were observed in the incidence of left ventricular remodelling (26.2% vs. 21.4%; p = 0.824) PMID 41942544 ↗
paper In conclusion, calcifediol does not improve left ventricular remodelling PMID 41942544 ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcifediol | Unknown | 0.266 mg | Oral |
| Subject | Calcifediol | Unknown | 15690 iu | Oral |