Vitamin D and Mortality in Heart Failure (EVITA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier:
NCT01326650
First received: March 29, 2011
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Congestive Heart Failure
Drug: Vitamin D
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D on All-cause Mortality in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Heart and Diabetes Center North-Rhine Westfalia:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Number of event-free survivors [ Time Frame: three years ] [ Designated as safety issue: No ]
    event defined as: cardiac transplantation, high urgent listing for cardiac transplantation, resuscitation, hospitalization, 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.



Enrollment: 400
Study Start Date: November 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
daily vitamin D supplement
Drug: Vitamin D
daily oral vitamin D supplement of 100 micrograms for three years
Placebo Comparator: placebo Drug: placebo
daily oral placebo supplement for three years

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326650

Locations
Germany
Heart Center North Rhine-Westphalia
Bad Oeynhausen, Federal State of North Rhine-Westphalia, Germany, 32545
Sponsors and Collaborators
Heart and Diabetes Center North-Rhine Westfalia
Investigators
Study Chair: Armin Zittermann, PhD Heart Center North Rhine-Westphalia
Principal Investigator: Jochen Börgermann, MD Heart Center North Rhine-Westphalia
  More Information

Publications:

Responsible Party: Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT01326650     History of Changes
Other Study ID Numbers: 004
Study First Received: March 29, 2011
Last Updated: July 15, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heart and Diabetes Center North-Rhine Westfalia:
vitamin D, mortality, event-free survival, heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 01, 2014