Vitamin D and Mortality in Heart Failure

Study Overview
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Brief Summary
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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.

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

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Drug: Vitamin D
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>daily vitamin D supplement | Drug: Vitamin D<br>* daily oral vitamin D supplement of 100 micrograms for three years<br>* Other names: solution of vitamin D oil;|
| Placebo Comparator: placebo<br>daily placebo supplement | Drug: placebo<br>* daily oral placebo supplement for three years<br>* Other names: solution of migliol oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who died during the intervention | 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 | event defined as: cardiac transplantation, high urgent listing for cardiac transplantation, resuscitation, ventricular assist device Implantation, hypercalcemia | three years | 
| Changes in biochemical risk markers | inflammation markers, kidney parameters, lipid parameters, haemostasis parameters | three years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, mortality, event-free survival, heart failure