The Role of Vitamin D in the Pathophysiology of Chronic Failure

Study Overview
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Brief Summary
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Patients will undergo at baseline and regular intervals: clinically indicated bloodwork/urine and echocardiogram testing biomarker studies Upon enrolment in the study patients will be divided into 4 groups normal, mildly deficient and severely deficient. Normal and mild vitamin D levels will receive no treatment while severe Vitamin D deficiency will be randomized (50/50) to receive no treatment or vitamin D treatment. They will be seen in the heart failure clinic every 6 months. The patients will be followed for 26 months.

Detailed Description
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The inclusion criteria for the study is: an EF ≤40% within the last 12 months before recruitment established diagnosis of heart failure >18 years of age patients will vitamin d levels of sufficient, mild deficiency and severe deficiency The exclusion criteria is: hypercalcemia known hypersensitivity to Vitamin D patient unwilling to comply with study requirements any other disease other than heart failure that can alter the patients quality of life over a period of 6 months women of child bearing potential a patient currently taking vitamin d severe renal impairment estimated glomerular filtration rate (eGFR) <30

Official Title
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The Role of Vitamin D in the Pathophysiology of Chronic Failure: Insight in to Mechanisms of Action and Implications for Vitamin D Supplementation

Conditions
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Vitamin D Deficiency, Chronic Heart Failure

Intervention / Treatment
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* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: an ejection fraction (EF) ≤40% within the last 12 months before recruitment established diagnosis of heart failure >18 years of age patients with Vitamin D levels of sufficient, mild deficiency and severe deficiency Exclusion Criteria: hypercalcemia known hypersensitivity to Vitamin D patient unwilling to comply with study requirements any other disease other than heart failure that can alter the patients quality of life over a period of 6 months women of child bearing potential a patient currently taking vitamin d severe renal impairment eGFR <30

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sufficeint<br>In this arm the participants have a Vitamin D level of greater than 75 ng/ml. They will continue to be monitored throughout the study but will not receive any intervention. | |
| No Intervention: Mild Insufficiency<br>In this arm the participants have a Vitamin D level between 37.5 - 75 ng/ml. The participants will be monitored throughout the study but will receive no intervention. | |
| No Intervention: Severe Deficiency no treatment<br>In this arm the participants have a low Vitamin D level of less than 37.5 ng/ml. The participants will be monitored but will receive no intervention. | |
| Experimental: Severe Deficiency - Treatment<br>In this arm the participants will be treated with Vitamin D. The participants will be prescribed a dose of 1000 IU a day (1 pill a day). At 6 weeks the dosage will increase to 2000 IU a day (2 pills a day). | Drug: Vitamin D<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of Vitamin D deficiency amongst chronic heart failure patients at the University of Ottawa Heart Institute | The primary outcome for the study is to identify the prevalence of Vitamin D deficiency amongst chronic heart failure patients followed at the University of Ottawa Heart Institute. This will be done analyzing the Vitamin D blood levels at baseline. | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that Vitamin D deficiency is associated with poor outcome and that Vitamin D supplementation can be of clinical benefit | clinical endpoints of: hospitalizations for worsening congestive heart failure, death will be compared for severe Vitamin D deficient patients receiving Vitamin D supplementation vs severe Vitamin D deficient patients receiving no intervention | up to 3 years |