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.

INTRODUCTION: Decreased plasma vitamin D (VD) levels are linked to cardiovascular damage. However, clinical trials have not demonstrated a benefit of VD supplements on left ventricular (LV) remodelling. Anterior ST-elevation acute myocardial infarction (STEMI) is the best human model to study the effect of treatments on LV remodelling. We present a proof-of-concept study that aims to investigate whether VD improves LV remodelling in patients with anterior STEMI. METHODS AND ANALYSIS: The VITamin D in Acute Myocardial Infarction (VITDAMI) trial is a multicentre, randomised, double-blind, placebo-controlled trial. 144 patients with anterior STEMI will be assigned to receive calcifediol 0.266 mg capsules (Hidroferol SGC)/15 days or placebo on a 2:1 basis during 12 months. PRIMARY OBJECTIVE: to evaluate the effect of calcifediol on LV remodelling defined as an increase in LV end-diastolic volume ≥10% (MRI). SECONDARY OBJECTIVES: change in LV end-diastolic and end-systolic volumes, ejection fraction, LV mass, diastolic function, sphericity index and size of fibrotic area; endothelial function; plasma levels of aminoterminal fragment of B-type natriuretic peptide, galectin-3 and monocyte chemoattractant protein-1; levels of calcidiol (VD metabolite) and other components of mineral metabolism (fibroblast growth factor-23 (FGF-23), the soluble form of its receptor klotho, parathormone and phosphate). Differences in the effect of VD will be investigated according to the plasma levels of FGF-23 and klotho. Treatment safety and tolerability will be assessed. This is the first study to evaluate the effect of VD on cardiac remodelling in patients with STEMI. ETHICS AND DISSEMINATION: This trial has been approved by the corresponding Institutional Review Board (IRB) and National Competent Authority (Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)). It will be conducted in accordance with good clinical practice (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP)) requirements, ethical principles of the Declaration of Helsinki and national laws. The results will be submitted to indexed medical journals and national and international meetings. TRIAL REGISTRATION NUMBER: NCT02548364; Pre-results.

Circulating fibroblast growth factor-23 plasma levels predict adverse cardiovascular outcomes in patients with diabetes mellitus with coronary artery disease.

BACKGROUND: Abnormalities of fibroblast growth factor-23 (FGF-23) plasma levels predict adverse outcomes in patients with coronary artery disease. However, FGF-23 has a different behaviour in the presence of type 2 diabetes mellitus (T2D). We explored whether the presence of T2D affects the predictive power of FGF-23. METHODS: In 704 patients with stable coronary artery disease, FGF-23, calcidiol, parathormone (PTH) and phosphate plasma levels were prospectively assessed. The primary outcome was the development of acute ischemic events (acute coronary syndrome, stroke or transient ischemic attack), heart failure or death. RESULTS: One hundred seventy-three (24.6%) patients had T2D, without differences in age, sex or estimated glomerular filtration rate as compared with non-diabetic patients. Serum PTH was lower and phosphate higher in T2D than in non-diabetic patients, without differences in FGF-23 or calcidiol levels. During follow-up (2.15 ± 0.99 years), 26 (15.2%) T2D and 51 (9.6%) non-diabetic patients developed the outcome (p = 0.048). T2D patients who developed the outcome had higher FGF-23 [112.0 (59.9, 167.6) vs 68.9 (54.2, 93.0) RU/mL; p = 0.002], PTH [71.3 (47.3, 106.6) vs 51.9 (40.8, 66.2) pg/mL; p = 0.004) and phosphate (3.53 ± 0.71 vs 3.25 ± 0.50 mg/dL; p = 0.017) levels than T2D subjects who remained stable. These differences were not significant in non-diabetic patients. By multivariable Cox proportional hazard model, FGF-23 predicted independently the outcome in T2D patients [hazard ratio = 1.277; 95% CI (1.132, 1.442)] but not in those without T2D. CONCLUSIONS: FGF-23 plasma levels predict adverse cardiovascular outcomes in coronary artery disease patients who have T2D but not in those without T2D. This finding should be confirmed in larger studies. Copyright © 2016 John Wiley & Sons, Ltd.

[Percutaneous aortic valve implantation: initial experience in Spain]. / Implantación percutánea de prótesis valvular aórtica: experiencia inicial en España.

Patients with symptomatic aortic stenosis have a very poor prognosis on medical treatment. In those with contraindications to surgery, percutaneous valve replacement has been proposed as an alternative. We report on physicians' initial experience in Spain with percutaneous aortic valve replacement. We analyzed inhospital and short-to-medium-term findings in four patients who underwent percutaneous implantation of a Cribier-Edwards prosthetic aortic valve. In all four cases, the Cribier-Edwards prosthetic valves were successfully implanted via the femoral artery. The procedures were guided by angiography and transesophageal echocardiography. Patients were discharged 3 to 5 days after the procedure and were still in a satisfactory clinical condition 3 months later. In summary, early experience in Spain with the percutaneous implantation of Cribier-Edwards prosthetic aortic valves indicates that it is a suitable alternative for patients for whom replacement surgery is contraindicated or would place them at a high risk.

Implantación percutánea de prótesis valvular aórtica: experiencia inicial en España / Percutaneous aortic valve implantation: initial experience in Spain

Los pacientes con estenosis aórtica sintomática tienen un pronóstico ominoso con tratamiento médico. En pacientes con contraindicación quirúrgica, se ha propuesto la implantación percutánea como alternativa. Presentamos la experiencia inicial en España de la implantación percutánea de prótesis valvular aórtica. Analizamos los resultados hospitalarios y a corto-medio plazo de 4 pacientes a quienes se implantó, de forma percutánea, una prótesis valvular aórtica de Cribier-Edwards. Las cuatro prótesis valvulares se implantaron con éxito por vía percutánea a través de la arteria femoral. El procedimiento fue guiado por angiografía y ecocardiografía transesofágica. Los pacientes fueron dados de alta entre 3 y 5 días después del procedimiento y siguen en buena situación clínica a los 3 meses. En conclusión, la experiencia inicial en España de implantación percutánea de prótesis valvular aórtica de Cribier-Edwards apunta en la dirección de una alternativa válida en pacientes con contraindicación o alto riesgo para la sustitución quirúrgica (AU)

Patients with symptomatic aortic stenosis have a very poor prognosis on medical treatment. In those with contraindications to surgery, percutaneous valve replacement has been proposed as an alternative. We report on physicians' initial experience in Spain with percutaneous aortic valve replacement. We analyzed inhospital and short-to-medium-term findings in 4 patients who underwent percutaneous implantation of a Cribier-Edwards prosthetic aortic valve. In all four cases, the Cribier-Edwards prosthetic valves were successfully implanted via the femoral artery. The procedures were guided by angiography and transesophageal echocardiography. Patients were discharged 3 to 5 days after the procedure and were still in a satisfactory clinical condition 3 months later. In summary, early experience in Spain with the percutaneous implantation of Cribier-Edwards prosthetic aortic valves indicates that it is a suitable alternative for patients for whom replacement surgery is contraindicated or would place them at a high risk (AU)