Vitamin D and Mortality in Heart Failure (EVITA)

This study is currently recruiting participants.
Verified December 2013 by Heart and Diabetes Center North-Rhine Westfalia
Sponsor:
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier:
NCT01326650
First received: March 29, 2011
Last updated: December 10, 2013
Last verified: December 2013

March 29, 2011
December 10, 2013
November 2010
June 2016   (final data collection date for primary outcome measure)
Number of participants who died during the intervention [ Time Frame: three years ] [ Designated as safety issue: No ]
all-cause mortality (any cause of death) will be assessed
Same as current
Complete list of historical versions of study NCT01326650 on ClinicalTrials.gov Archive Site
  • Number of event-free survivors [ Time Frame: three years ] [ Designated as safety issue: No ]
    event defined as: death from any course, cardiac transplantation, high urgent listing for cardiac transplantation, rescucitation, hospitalisation, ventricular assist device implantation
  • Changes in biochemical risk markers [ Time Frame: three years ] [ Designated as safety issue: No ]
    inflammation markers, kidney parameters, lipid parameters, haemostasis parameters
  • Number of participants with elevated safety parameters [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]

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

    Serum calcium should not exceed 2.75 mmol/l.

Same as current
Not Provided
Not Provided
 
Vitamin D and Mortality in Heart Failure
Effect of Vitamin D on All-cause Mortality in Heart Failure Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Congestive Heart Failure
  • Drug: Vitamin D
    daily oral vitamin D supplement of 100 mikrograms for three years
  • Drug: placebo
    daily oral placebo supplement for three years
  • Experimental: Vitamin D
    daily vitamin D supplement
    Intervention: Drug: Vitamin D
  • Placebo Comparator: placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
June 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • preganncyand lactation
  • sarcoidosis
  • chronic kidney disease (stage 4 and 5)
  • daily vitamin D intake > 20 mikrograms
  • serum 25-hydroxyvitamin D > 30 ng/ml
  • hypercalcemia
Both
18 Years to 79 Years
No
Not Provided
Germany
 
NCT01326650
004
Yes
Heart and Diabetes Center North-Rhine Westfalia
Heart and Diabetes Center North-Rhine Westfalia
Not Provided
Study Chair: Armin Zittermann, PhD Heart Center North Rhine-Westphalia
Principal Investigator: Jochen Börgermann, MD Heart Center North Rhine-Westphalia
Heart and Diabetes Center North-Rhine Westfalia
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP