VitamIN D Treating patIents With Chronic heArT failurE

Study Overview
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Brief Summary
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Despite recent advances and even when receiving optimal therapy, patients with chronic heart failure (CHF) suffer poor quality of life, with recurrent hospitalisations and persistent symptoms. The investigators have shown that patients attending the Leeds Integrated Heart Failure Service are also frequently deficient in vitamin D and that the severity of the deficiency relates to the levels of symptoms, exercise capacity, diuretic requirements and response to optimal medical therapy. Vitamin D contributes to cardiac and skeletal muscle contractile function, immune function, pancreatic insulin release, and neuro-hormonal homeostasis. A randomised, placebo-controlled proof of concept study in 60 CHF patients has demonstrated improvements in submaximal exercise capacity and symptoms. VINDICATE will be a randomised, placebo-controlled developmental clinical study in 250 patients with CHF and vitamin D deficiency. The present study is designed to detect whether vitamin D has pathophysiologically important effects, as well as providing preliminary evidence of efficacy and safety by examining cardiac function (using cardiac magnetic resonance imaging) and submaximal exercise capacity (by 6-minute walk test). This will provide pertinent data to inform a larger multi-centre efficacy and effectiveness study.

Detailed Description
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This is a randomized placebo-controlled trial of vitamin D versus placebo in people with heart failure. Primary endpoint is 6 minute walk distance.

Official Title
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VitamIN D Treating patIents With Chronic heArT failurE

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Dietary Supplement: Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Class II or III CHF Stable symptoms (on otherwise optimally tolerated medical therapy) Able to give written informed consent Exclusion Criteria: Currently taking vitamin D supplementation Untreated valvular heart disease Existing class I indication for vitamin D therapy History of primary hyperparathyroidism, tuberculosis, sarcoidosis, malignancy or hypercalcaemia Heart failure due to anaemia or thyrotoxicosis Renal failure (GFR <30l/min)

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Vitamin D<br>Vitamin D 100mcg per day | Dietary Supplement: Vitamin D<br>* 100mcg per day<br>|
| Placebo Comparator: Placebo<br>Standard optimal therapy | Dietary Supplement: Vitamin D<br>* 100mcg per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk distance |  | After one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular function by Cardiac Magnetic Resonance |  | At one year | 
| Peak exercise capacity |  | At one year | 
| Biochemical changes |  | At one year (but also throughout) |