Vitamin D and Mortality in Heart Failure (EVITA)

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D
daily vitamin D supplement
daily oral vitamin D supplement of 100 micrograms for three years
Other Names:
  • solution of vitamin D oil
Placebo Comparator: placebo
daily placebo supplement
daily oral placebo supplement for three years
Other Names:
  • solution of migliol oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who died during the intervention
Time Frame: three years
all-cause mortality (any cause of death) will be assessed
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
three years
Changes in biochemical risk markers
Time Frame: three years
inflammation markers, kidney parameters, lipid parameters, haemostasis parameters
three years
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.

every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Armin Zittermann, PhD, Heart Center North Rhine-Westphalia
  • Principal Investigator: Jochen Börgermann, MD, Heart Center North Rhine-Westphalia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

March 29, 2011

First Submitted That Met QC Criteria

March 30, 2011

First Posted (Estimate)

March 31, 2011

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

September 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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