Micronutrient Supplementation in Patients With Heart Failure

Study Overview
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Brief Summary
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There is some evidence to suggest that patients with heart failure may have a reduced dietary intake of vitamins and essential minerals (micronutrients) and that this may worsen the function of the heart. This study is designed to investigate if supplementation with micronutrients (including high-dose vitamin D) will improve the function of the heart in patients with heart failure.

Official Title
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A Trial of Micronutrient Supplementation in Patients With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Placebo
* Drug: Forceval plus 50 micrograms Vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New York Heart Association Class II and III Already on or tried on best known medical treatment (ACE inhibitor and beta-blocker) Stable for a period of at least 6 weeks Left ventricular ejection fraction less than or equal to 45% Exclusion Criteria: History of significant alcohol ingestion (more than 40 units per week) Severe renal dysfunction (GFR less than 30ml/min) Severe hepatic dysfunction (known liver disease or transaminases greater than 3 times the upper limit of normal) Atrial fibrillation (in the absence of a pacemaker) Frequent ventricular ectopics On waiting list for cardiac transplantation Uncontrolled diabetes mellitus Inability to give informed consent Estimated life span less than 12 months Already taking a multivitamin/mineral supplement Already taking a vitamin-D containing fish oil Woman of child-bearing potential History of renal stones, hypercalcaemia, sarcoidosis, haemochromatosis or lactose intolerance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 Tablet Daily<br>|
| Active Comparator: Micronutrient<br> | Drug: Forceval plus 50 micrograms Vitamin D3<br>* Forceval: 1 Tablet Daily; Vitamin D3: 2 Tablets Daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Ejection Fraction |  | Baseline, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Questionnaire Score | Minnesota Living With Heart Failure Questionnaire. The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses (score range 0-105). Higher scores indicate worse quality of life. | Baseline, and 12 months | 
| Six Minute Walk Test Distance |  | Baseline, and 12 months | 
| Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration |  | Baseline, and 12 months | 
| Serum C-reactive Protein (CRP) Concentration |  | Baseline, and 12 months | 
| Serum Tumor Necrosis Factor-alpha (TNF-α) Concentration |  | Baseline, and 12 months | 
| Serum Interleukin-6 (IL-6) Concentration |  | Baseline, and 12 months | 
| Serum Interleukin-10 (IL-10) Concentration |  | Baseline, and 12 months | 
| Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration |  | Baseline, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Micronutrients, Vitamin D, Inflammation, Oxidative Stress, Quality of Life, Physical Functioning