Vitamin D and Mortality in Heart Failure (EVITA)

Heart and Diabetes Center North-Rhine Westfalia

Status and phase: Completed; Phase 4

Conditions: Congestive Heart Failure

Treatments: Drug: placebo; Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01326650

004

Details and patient eligibility

About

Despite significant therapeutic improvements, congestive heart failure (CHF) patients still have a poor prognosis. Currently, 5-year survival rates are only 35-50%. There is an accumulating body of evidence from prospective cohort studies that low circulating 25-hydroxyvitamin D is an independent predictor of all-cause and cardiovascular mortality, respectively. Vitamin D deficiency is prevalent among CHF patients. We hypothesize that vitamin D may improve survival in CHF patients. We therefore aimed to investigate whether vitamin D supplementation reduces mortality and increases event-free survival in end-stage CHF patients.

Enrollment: 400 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 18 years of age and < 80 years of age
• New York Heart Association Functional Class > = II

Exclusion criteria

• pregnancy and lactation
• sarcoidosis
• daily vitamin D intake > 20 micrograms
• serum 25-hydroxyvitamin D > 30 ng/ml
• hypercalcemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Vitamin D

Experimental group

Description:

daily vitamin D supplement

Treatment:

Drug: Vitamin D

placebo

Placebo Comparator group

Description:

daily placebo supplement

Treatment:

Drug: placebo