Micronutrient Supplementation in Patients With Heart Failure

• Status: Unknown status
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Belfast Health and Social Care Trust
• Treatments: Cholecalciferol; Ergocalciferols; Micronutrients; Trace Elements; Vitamin D; Vitamins

Criteria

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