VINDICATE 2 will be a randomised, placebo-controlled, parallel group, double-blind study of vitamin D versus placebo in otherwise optimally-managed patients with CHF due to LVSD and vitamin D deficiency (\<50nmol/L). The intervention will be a daily dose of 4000IU (100µg) per day or matching placebo for a minimum of 2 years and a maximum of 4 years.
LVSD (LVEF <50%);
stable medical and device therapy for >3mths;
25[OH]vitamin D3 <50nmol/L
At least one of: recent (<1 year) hospitalisation for HF, high dose loop diuretic requirement (>80mg daily furosemide equiv), diabetes mellitus, ischaemic aetiology
Unwilling/unable to sign consent,
Severe cognitive impairment,
Severe COPD,
Anaemia,
Parallel
4000IU Vitamin D3
Dietary supplementChewable blackcurrant flavoured tablets (two per day)
Combined heart failure hospitalisation and total mortality
Time to death or first hospitalisation for heart failure
Total mortality
Time to death
Cost effectiveness
ICER for vitamin D
Change in patient quality of life
EQ5D - 5L
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