Effects of Vitamin D on Cardiac Function in Patients With Chronic HF: The VINDICATE Study
Witte KK, Byrom R, Gierula J, Paton MF, Jamil HA, Lowry JE, Gillott RG, Barnes SA, Chumun H, Kearney LC, Greenwood JP, Plein S, Law GR, Pavitt S, Barth JH, Cubbon RM, Kearney MT
Journal of the American College of Cardiology · 161 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institute for Health and Care Research
- Organización sin fines de lucro
- British Heart Foundation
- Universidad u hospital
- University of Leeds
- Gobierno
- National Institutes of Health
- Gobierno
- Medical Research Council
- Gobierno
- National Institute for Health Research (NIHR)
- Subvenciones
- British Heart Foundation (RG/09/010/28087); British Heart Foundation (FS/12/80/29821); National Institute for Health and Care Research (HCS DRF-2014-05-006); Medical Research Council (MR/J00281X/1); British Heart Foundation (FS/10/028/28252)
Según 6 financiadores declarados.
Publicación
- Publicado
- 2016-04-04 · J Am Coll Cardiol · vol. 67 · número 22 · págs. 2593–2603
- Editorial
- Elsevier BV
- Citado
- 228 citas · más que el 100% de estudios similares · 22.8× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 45 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY
- Áreas de investigación
- Vitamin D Research Studies · GDF15 and Related Biomarkers · Cardiac Fibrosis and Remodeling
- Palabras clave
- Medicine, Vitamin D and neurology, Cholecalciferol, Ejection fraction, Heart failure, Internal medicine, Clinical endpoint, Vitamin, vitamin D deficiency, Placebo, Cardiology, Confidence interval, Cardiac function curve, Endocrinology, Clinical trial, Pathology
- MeSH
- heart ventricles, humans, ventricular dysfunction, left, cholecalciferol, calcifediol, calcitriol, vitamins, magnetic resonance imaging, cine, echocardiography, stroke volume, double-blind method, systole, ventricular remodeling, aged, middle aged, female, male, heart failure, walk test
17 autores
- Klaus Karl Witte🇬🇧 · autor de correspondenciaUniversity of Leeds; Leeds Beckett University
- Rowena Byrom🇬🇧University of Leeds
- John Gierula🇬🇧University of Leeds
- Maria F. Paton🇬🇧University of Leeds
- Haqeel A. Jamil🇬🇧University of Leeds
- Judith E. Lowry🇬🇧University of Leeds
- Richard Gillott🇬🇧Leeds Teaching Hospitals NHS Trust
- Sally A. Barnes🇬🇧Leeds Teaching Hospitals NHS Trust
- Hemant Chumun🇬🇧University of Leeds
- Lorraine C. Kearney🇬🇧University of Leeds
- John Pierre Greenwood🇬🇧University of Leeds
- Sven Plein🇬🇧University of Leeds
- Graham Richard Law🇬🇧University of Leeds
- Sue H. Pavitt🇬🇧University of Leeds
- Julian H. Barth🇬🇧Leeds Teaching Hospitals NHS Trust
- Richard M. Cubbon🇬🇧University of Leeds
- Mark T. Kearney🇬🇧University of Leeds
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Patients with chronic heart failure (HF) secondary to left ventricular systolic dysfunction (LVSD) are frequently deficient in vitamin D. Low vitamin D levels are associated with a worse prognosis.
Objectives
The VINDICATE (VitamIN D treatIng patients with Chronic heArT failurE) study was undertaken to establish safety and efficacy of high-dose 25 (OH) vitamin D3 (cholecalciferol) supplementation in patients with chronic HF due to LVSD.
Methods
We enrolled 229 patients (179 men) with chronic HF due to LVSD and vitamin D deficiency (cholecalciferol <50 nmol/l [<20 ng/ml]). Participants were allocated to 1 year of vitamin D3 supplementation (4,000 IU [100 μg] daily) or matching non-calcium-based placebo. The primary endpoint was change in 6-minute walk distance between baseline and 12 months. Secondary endpoints included change in LV ejection fraction at 1 year, and safety measures of renal function and serum calcium concentration assessed every 3 months.
Results
One year of high-dose vitamin D3 supplementation did not improve 6-min walk distance at 1 year, but was associated with a significant improvement in cardiac function (LV ejection fraction +6.07% [95% confidence interval (CI): 3.20 to 8.95; p < 0.0001]); and a reversal of LV remodeling (LV end diastolic diameter -2.49 mm [95% CI: -4.09 to -0.90; p = 0.002] and LV end systolic diameter -2.09 mm [95% CI: -4.11 to -0.06 p = 0.043]).
Conclusions
One year of 100 μg daily vitamin D3 supplementation does not improve 6-min walk distance but has beneficial effects on LV structure and function in patients on contemporary optimal medical therapy. Further studies are necessary to determine whether these translate to improvements in outcomes. (VitamIN D Treating patIents With Chronic heArT failurE [VINDICATE]; NCT01619891).
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