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Eur Heart J. 2017 Aug 1;38(29):2279-2286. doi: 10.1093/eurheartj/ehx235.

Effect of vitamin D on all-cause mortality in heart failure (EVITA): a 3-year randomized clinical trial with 4000 IU vitamin D daily.

Author information

1
Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr University Bochum, Georgstraße 11, 32545 Bad Oeynhausen, Germany.
2
Institute for Laboratory and Transfusion Medicine, Heart and Diabetes Center NRW, Ruhr University Bochum, Georgstraße 11, 32545 Bad Oeynhausen, Germany.
3
Department of Internal Medicine and Geriatrics, Evangelical Hospital of the Bethel Foundation, Schildescher Straße 99, 33611 Bielefeld, Germany.
4
Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036 Graz, Austria.
5
Center of Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Kerpener Straße 62, 50937 Cologne, Germany.
6
Department of Bioinformatics, Institute of Human Genetics, Biocenter, University of Wuerzburg, Am Hubland/Biozentrum, 97074 Wuerzburg, Germany.

Abstract

Aims:

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.

Methods and results:

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).

Conclusion:

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.

Trial Registration Information:

clinicaltrials.gov Idenitfier: NCT01326650.

KEYWORDS:

Calcium; Heart failure; Hypercalcaemia; Mechanical circulatory support; Mortality; Randomized clinical trial; Survival; Vitamin D

PMID:
28498942
DOI:
10.1093/eurheartj/ehx235
[Indexed for MEDLINE]

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