- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01326650
Vitamin D and Mortality in Heart Failure (EVITA)
August 10, 2016 updated by: Heart and Diabetes Center North-Rhine Westfalia
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
Conditions
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:
|
Placebo Comparator: placebo
daily placebo supplement
|
daily oral placebo supplement for three years
Other Names:
|
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
- Zittermann A, Schleithoff SS, Gotting C, Fuchs U, Kuhn J, Kleesiek K, Tenderich G, Koerfer R. Calcitriol deficiency and 1-year mortality in cardiac transplant recipients. Transplantation. 2009 Jan 15;87(1):118-24. doi: 10.1097/TP.0b013e31818c2708.
- Schleithoff SS, Zittermann A, Tenderich G, Berthold HK, Stehle P, Koerfer R. Vitamin D supplementation improves cytokine profiles in patients with congestive heart failure: a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2006 Apr;83(4):754-9. doi: 10.1093/ajcn/83.4.754.
- Zittermann A, Schleithoff SS, Frisch S, Gotting C, Kuhn J, Koertke H, Kleesiek K, Tenderich G, Koerfer R. Circulating calcitriol concentrations and total mortality. Clin Chem. 2009 Jun;55(6):1163-70. doi: 10.1373/clinchem.2008.120006. Epub 2009 Apr 9.
- Zittermann A, Frisch S, Berthold HK, Gotting C, Kuhn J, Kleesiek K, Stehle P, Koertke H, Koerfer R. Vitamin D supplementation enhances the beneficial effects of weight loss on cardiovascular disease risk markers. Am J Clin Nutr. 2009 May;89(5):1321-7. doi: 10.3945/ajcn.2008.27004. Epub 2009 Mar 25.
- Zittermann A, Schleithoff SS, Gotting C, Dronow O, Fuchs U, Kuhn J, Kleesiek K, Tenderich G, Koerfer R. Poor outcome in end-stage heart failure patients with low circulating calcitriol levels. Eur J Heart Fail. 2008 Mar;10(3):321-7. doi: 10.1016/j.ejheart.2008.01.013. Epub 2008 Mar 4.
- Zittermann A, Fischer J, Schleithoff SS, Tenderich G, Fuchs U, Koerfer R. Patients with congestive heart failure and healthy controls differ in vitamin D-associated lifestyle factors. Int J Vitam Nutr Res. 2007 Jul;77(4):280-8. doi: 10.1024/0300-9831.77.4.280.
- Zittermann A, Schleithoff SS, Tenderich G, Berthold HK, Korfer R, Stehle P. Low vitamin D status: a contributing factor in the pathogenesis of congestive heart failure? J Am Coll Cardiol. 2003 Jan 1;41(1):105-12. doi: 10.1016/s0735-1097(02)02624-4.
- Zittermann A, Ernst JB, Prokop S, Fuchs U, Dreier J, Kuhn J, Knabbe C, Borgermann J, Berthold HK, Pilz S, Gouni-Berthold I, Gummert JF. Daily Supplementation with 4000 IU Vitamin D3 for Three Years Does Not Modify Cardiovascular Risk Markers in Patients with Advanced Heart Failure: The Effect of Vitamin D on Mortality in Heart Failure Trial. Ann Nutr Metab. 2019;74(1):62-68. doi: 10.1159/000495662. Epub 2018 Dec 14.
- Ernst JB, Prokop S, Fuchs U, Dreier J, Kuhn J, Knabbe C, Berthold HK, Pilz S, Gouni-Berthold I, Gummert JF, Borgermann J, Zittermann A. Randomized supplementation of 4000 IU vitamin D3 daily vs placebo on the prevalence of anemia in advanced heart failure: the EVITA trial. Nutr J. 2017 Aug 23;16(1):49. doi: 10.1186/s12937-017-0270-5.
- Zittermann A, Ernst JB, Prokop S, Fuchs U, Dreier J, Kuhn J, Knabbe C, Birschmann I, Schulz U, Berthold HK, Pilz S, Gouni-Berthold I, Gummert JF, Dittrich M, Borgermann J. Effect of vitamin D on all-cause mortality in heart failure (EVITA): a 3-year randomized clinical trial with 4000 IU vitamin D daily. Eur Heart J. 2017 Aug 1;38(29):2279-2286. doi: 10.1093/eurheartj/ehx235.
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 004
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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