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Completed

NCT Number: NCT01326650

Vitamin D and Mortality in Heart Failure

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Heart Center North Rhine-Westphalia

Bad Oeynhausen, Federal State of North Rhine-Westphalia, 32545, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

daily oral vitamin D supplement of 100 micrograms for three years

Other names: solution of vitamin D oil

Placebo

Drug

daily oral placebo supplement for three years

Other names: solution of migliol oil

Primary outcomes

  1. Number of participants who died during the intervention

    Time frame: three years

    all-cause mortality (any cause of death) will be assessed

Secondary outcomes

  1. Number of event-free survivors

    Time frame: three years

    event defined as: cardiac transplantation, high urgent listing for cardiac transplantation, resuscitation, ventricular assist device Implantation, hypercalcemia

  2. Changes in biochemical risk markers

    Time frame: three years

    inflammation markers, kidney parameters, lipid parameters, haemostasis parameters

  3. Number of participants with elevated safety parameters

    Time frame: every 6 months

    Serum 25-Hydroxyvitamin D should not exceed 150 ng/ml.

    Serum calcium should not exceed 2.75 mmol/l.

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Official study title

Effect of Vitamin D on All-cause Mortality in Heart Failure Patients

Acronym: EVITA

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2011
Registry last updated
Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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