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Vitamin D and Mortality in Heart Failure (EVITA)

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Vitamin D
placebo
Sponsored by
Heart and Diabetes Center North-Rhine Westfalia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring vitamin D, mortality, event-free survival, heart failure

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Center North Rhine-Westphalia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D

placebo

Arm Description

daily vitamin D supplement

daily placebo supplement

Outcomes

Primary Outcome Measures

Number of participants who died during the intervention
all-cause mortality (any cause of death) will be assessed

Secondary Outcome Measures

Number of event-free survivors
event defined as: cardiac transplantation, high urgent listing for cardiac transplantation, resuscitation, ventricular assist device Implantation, hypercalcemia
Changes in biochemical risk markers
inflammation markers, kidney parameters, lipid parameters, haemostasis parameters
Number of participants with elevated safety parameters
Serum 25-Hydroxyvitamin D should not exceed 150 ng/ml. Serum calcium should not exceed 2.75 mmol/l.

Full Information

First Posted
March 29, 2011
Last Updated
August 10, 2016
Sponsor
Heart and Diabetes Center North-Rhine Westfalia
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1. Study Identification

Unique Protocol Identification Number
NCT01326650
Brief Title
Vitamin D and Mortality in Heart Failure
Acronym
EVITA
Official Title
Effect of Vitamin D on All-cause Mortality in Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heart and Diabetes Center North-Rhine Westfalia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
vitamin D, mortality, event-free survival, heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
daily vitamin D supplement
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
daily placebo supplement
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
solution of vitamin D oil
Intervention Description
daily oral vitamin D supplement of 100 micrograms for three years
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
solution of migliol oil
Intervention Description
daily oral placebo supplement for three years
Primary Outcome Measure Information:
Title
Number of participants who died during the intervention
Description
all-cause mortality (any cause of death) will be assessed
Time Frame
three years
Secondary Outcome Measure Information:
Title
Number of event-free survivors
Description
event defined as: cardiac transplantation, high urgent listing for cardiac transplantation, resuscitation, ventricular assist device Implantation, hypercalcemia
Time Frame
three years
Title
Changes in biochemical risk markers
Description
inflammation markers, kidney parameters, lipid parameters, haemostasis parameters
Time Frame
three years
Title
Number of participants with elevated safety parameters
Description
Serum 25-Hydroxyvitamin D should not exceed 150 ng/ml. Serum calcium should not exceed 2.75 mmol/l.
Time Frame
every 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Zittermann, PhD
Organizational Affiliation
Heart Center North Rhine-Westphalia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jochen Börgermann, MD
Organizational Affiliation
Heart Center North Rhine-Westphalia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center North Rhine-Westphalia
City
Bad Oeynhausen
State/Province
Federal State of North Rhine-Westphalia
ZIP/Postal Code
32545
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19359534
Citation
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.
Results Reference
background
PubMed Identifier
19321573
Citation
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.
Results Reference
background
PubMed Identifier
19136901
Citation
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.
Results Reference
background
PubMed Identifier
18304873
Citation
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.
Results Reference
background
PubMed Identifier
18271283
Citation
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.
Results Reference
background
PubMed Identifier
16600924
Citation
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.
Results Reference
background
PubMed Identifier
12570952
Citation
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.
Results Reference
background
PubMed Identifier
30554193
Citation
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.
Results Reference
derived
PubMed Identifier
28835271
Citation
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.
Results Reference
derived
PubMed Identifier
28498942
Citation
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.
Results Reference
derived

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Vitamin D and Mortality in Heart Failure

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