Micronutrient Supplementation in Patients With Heart Failure (MINT-HF)

Belfast Health and Social Care Trust

Status and phase

Completed

Phase 3

Phase 2

Conditions

Heart Failure

Treatments

Drug: Forceval plus 50 micrograms Vitamin D3

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01005303

RGHT000395

Details and patient eligibility

About

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.

Enrollment

79 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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