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Zittermann, A; Ernst, JB; Prokop, S; Fuchs, U; Dreier, J; Kuhn, J; Knabbe, C; Birschmann, I; Schulz, U; Berthold, HK; Pilz, S; Gouni-Berthold, I; Gummert, JF; Dittrich, M; Börgermann, J.
Effect of vitamin D on all-cause mortality in heart failure (EVITA): a 3-year randomized clinical trial with 4000 IU vitamin D daily.
Eur Heart J. 2017; 38(29):2279-2286
Doi: 10.1093/eurheartj/ehx235
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- Co-Autor*innen der Med Uni Graz
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Pilz Stefan
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- Abstract:
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Circulating 25-hydroxyvitamin D (25OHD) levels <75 nmol/L are associated with a nonlinear increase in mortality risk. Such 25OHD levels are common in heart failure (HF). We therefore examined whether oral vitamin D supplementation reduces mortality in patients with advanced HF.
Four hundred HF patients with 25OHD levels <75 nmol/L were randomized to receive 4000 IU vitamin D daily or matching placebo for 3 years. Primary endpoint was all-cause mortality. Key secondary outcome measures included hospitalization, resuscitation, mechanical circulatory support (MCS) implant, high urgent listing for heart transplantation, heart transplantation, and hypercalcaemia. Initial 25OHD levels were on average <40 nmol/L, remained around 40 nmol/L in patients assigned to placebo and plateaued around 100 nmol/L in patients assigned to vitamin D. Mortality was not different in patients receiving vitamin D (19.6%; n = 39) or placebo (17.9%; n = 36) with a hazard ratio (HR) of 1.09 [95% confidence interval (CI): 0.69-1.71; P = 0.726]. The need for MCS implant was however greater in patients assigned to vitamin D (15.4%, n = 28) vs. placebo [9.0%, n = 15; HR: 1.96 (95% CI: 1.04-3.66); P = 0.031]. Other secondary clinical endpoints were similar between groups. The incidence of hypercalcaemia was 6.2% (n = 10) and 3.1% (n = 5) in patients receiving vitamin D or placebo (P = 0.192).
A daily vitamin D dose of 4000 IU did not reduce mortality in patients with advanced HF but was associated with a greater need for MCS implants. Data indicate caution regarding long-term supplementation with moderately high vitamin D doses.
clinicaltrials.gov Idenitfier: NCT01326650.
Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.
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Cardiomyopathy, Dilated - complications
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Cardiomyopathy, Dilated - mortality
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Cause of Death -
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Dietary Supplements -
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Female -
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Heart Failure - diet therapy
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Heart Failure - mortality
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Heart Transplantation - mortality
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Heart Transplantation - statistics & numerical data
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Heart-Assist Devices - statistics & numerical data
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Hospitalization - statistics & numerical data
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Humans -
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Kaplan-Meier Estimate -
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Male -
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Middle Aged -
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Myocardial Ischemia - complications
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Myocardial Ischemia - mortality
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Prospective Studies -
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Risk Factors -
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Treatment Outcome -
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Vitamin D - administration & dosage
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Vitamin D - analogs & derivatives
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Vitamin D - metabolism
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Vitamin D Deficiency - diet therapy
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Vitamins - administration & dosage
- Find related publications in this database (Keywords)
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Vitamin D
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Heart failure
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Randomized clinical trial
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Mortality
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Survival
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Calcium
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Hypercalcaemia
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Mechanical circulatory support