Vitamin D and Mortality in Heart Failure

Congestive Heart Failure Clinical Trial

— EVITA  

Official title:

Effect of Vitamin D on All-cause Mortality in Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326650
• Other study ID #: 004
• Status: Completed
• Phase: Phase 4
• First received: March 29, 2011
• Last updated: August 10, 2016
• Start date: November 2010
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• Vitamin D
daily oral vitamin D supplement of 100 micrograms for three years
• placebo
daily oral placebo supplement for three years

Locations

Country	Name	City	State
Germany	Heart Center North Rhine-Westphalia	Bad Oeynhausen	Federal State of North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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. — View 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. — View Citation

Zittermann A, Frisch S, Berthold HK, Götting 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. — View Citation

Zittermann A, Schleithoff SS, Frisch S, Götting 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. — View Citation

Zittermann A, Schleithoff SS, Götting 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. — View Citation

Zittermann A, Schleithoff SS, Götting 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. — View Citation

Zittermann A, Schleithoff SS, Tenderich G, Berthold HK, Körfer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who died during the intervention	all-cause mortality (any cause of death) will be assessed	three years	No
Secondary	Number of event-free survivors	event defined as: cardiac transplantation, high urgent listing for cardiac transplantation, resuscitation, ventricular assist device Implantation, hypercalcemia	three years	No
Secondary	Changes in biochemical risk markers	inflammation markers, kidney parameters, lipid parameters, haemostasis parameters	three years	No
Secondary	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.	every 6 months	Yes