<p>No clinical trial has yet assessed the effect of vitamin D on patients experiencing ST-segment elevation myocardial infarction (STEMI). In this multicentre, randomised (2:1), double-blind, placebo-controlled trial, 93 patients with anterior STEMI were randomised to calcifediol or placebo, for 12&#xa0;months. The primary endpoint was left ventricular remodelling, defined as a 15% increase in left ventricular end-diastolic volume (EDV) on magnetic resonance imaging. Sixty-five patients were allocated to calcifediol and 28 to placebo. Calcidiol levels increased in the intervention group (20.0[8.4, 36.5] vs. 2.0[− 0.3, 4.5] ng/mL, <i>p</i> &lt; 0.001). No differences were observed in the incidence of left ventricular remodelling (26.2% vs. 21.4%; <i>p</i> = 0.824) and in these secondary end points: increment in end-diastolic volume (6.0[− 6.5, 21.6] vs. 6.1[− 8.1, 23.8] mL; <i>p</i> = 0.773), end-systolic volume (− 6.9[− 15.9, 4.5] vs. 1.3[− 20.9, 17.2] mL; <i>p</i> = 0.908), ejection fraction (5.1[2.1, 10.0] vs. 7.7[− 0.9, 11.0]%; <i>p</i> = 0.992), and in plasma levels of N-terminal pro-brain natriuretic peptide, galectin-3, ST2, growth differentiation factor-15, fibroblast growth factor-23 (FGF23), high-sensitivity C-reactive protein, and monocyte chemoattractant protein-1. Similar results were observed in patients with baseline FGF23 above the median, in those with calcidiol &lt; 30&#xa0;ng/mL, and in the subgroup with ejection fraction ≤ 40%. In conclusion, calcifediol does not improve left ventricular remodelling or affect biomarkers related to heart failure and inflammation following a STEMI.</p><p><b>Trial registration</b>: NCT02548364. <a href="https://clinicaltrials.gov/study/NCT02548364?term=VITDAMI%20Vitamin%20D%20in%20acute%20myocardial%20infarction%26rank=1">https://clinicaltrials.gov/study/NCT02548364?term=VITDAMI%20Vitamin%20D%20in%20acute%20myocardial%20infarction&amp;rank=1</a>.</p>

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Vitamin D in the prevention of left ventricular remodelling after an acute myocardial infarction: a randomized clinical trial

  • José Tuñón,
  • Carlos Rodríguez-López,
  • Jorge Balaguer,
  • Sandra Gómez-Talavera,
  • Antonio Rojas,
  • Jorge Salamanca,
  • Cecilia López García,
  • María Asunción Esteve-Pastor,
  • Ana Laffond,
  • Cristian Herrera,
  • Juan M. Escudier-Villa,
  • Miguel Orejas,
  • Marta Tomás,
  • María López Álvarez,
  • Mireia Arcas Tomeo,
  • Lucía Llanos-Jiménez,
  • Óscar González-Lorenzo,
  • Andrea Kallmeyer,
  • Borja Ibáñez,
  • María Luisa González-Casaus,
  • Gonzalo Hernández,
  • Cristina Espadas,
  • Óscar Lorenzo,
  • Ignacio Mahíllo-Fernández,
  • Jesús Egido,
  • Pedro Luis Sánchez,
  • Francisco Marín,
  • Fernando Alfonso

摘要

No clinical trial has yet assessed the effect of vitamin D on patients experiencing ST-segment elevation myocardial infarction (STEMI). In this multicentre, randomised (2:1), double-blind, placebo-controlled trial, 93 patients with anterior STEMI were randomised to calcifediol or placebo, for 12 months. The primary endpoint was left ventricular remodelling, defined as a 15% increase in left ventricular end-diastolic volume (EDV) on magnetic resonance imaging. Sixty-five patients were allocated to calcifediol and 28 to placebo. Calcidiol levels increased in the intervention group (20.0[8.4, 36.5] vs. 2.0[− 0.3, 4.5] ng/mL, p < 0.001). No differences were observed in the incidence of left ventricular remodelling (26.2% vs. 21.4%; p = 0.824) and in these secondary end points: increment in end-diastolic volume (6.0[− 6.5, 21.6] vs. 6.1[− 8.1, 23.8] mL; p = 0.773), end-systolic volume (− 6.9[− 15.9, 4.5] vs. 1.3[− 20.9, 17.2] mL; p = 0.908), ejection fraction (5.1[2.1, 10.0] vs. 7.7[− 0.9, 11.0]%; p = 0.992), and in plasma levels of N-terminal pro-brain natriuretic peptide, galectin-3, ST2, growth differentiation factor-15, fibroblast growth factor-23 (FGF23), high-sensitivity C-reactive protein, and monocyte chemoattractant protein-1. Similar results were observed in patients with baseline FGF23 above the median, in those with calcidiol < 30 ng/mL, and in the subgroup with ejection fraction ≤ 40%. In conclusion, calcifediol does not improve left ventricular remodelling or affect biomarkers related to heart failure and inflammation following a STEMI.

Trial registration: NCT02548364. https://clinicaltrials.gov/study/NCT02548364?term=VITDAMI%20Vitamin%20D%20in%20acute%20myocardial%20infarction&rank=1.