Congestive Heart Failure Clinical Trial
— EVITAOfficial title:
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Heart Center North Rhine-Westphalia | Bad Oeynhausen | Federal State of North Rhine-Westphalia |
Lead Sponsor | Collaborator |
---|---|
Heart and Diabetes Center North-Rhine Westfalia |
Germany,
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
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 |
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