Micronutrient Supplementation in Patients With Heart Failure

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Micronutrient	Forceval plus 50 micrograms Vitamin D3	-

Primary Outcome Measures

Name	Time	Method
Left Ventricular Ejection Fraction	Baseline, and 12 months

Secondary Outcome Measures

Name	Time	Method
Serum Interleukin-6 (IL-6) Concentration	Baseline, and 12 months
Quality of Life Questionnaire Score	Baseline, and 12 months	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.
Six Minute Walk Test Distance	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-10 (IL-10) Concentration	Baseline, and 12 months
Serum N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Concentration	Baseline, and 12 months
Urinary 8-iso-prostaglandin F2 Alpha (8-iso-PGF2α) Concentration	Baseline, and 12 months