Not Yet RecruitingNot Applicable

VItamiN D treatIng Chronic heArT Failure (the Effect of Vitamin D Supplementation in Patients With Heart Failure)

United Kingdom1,253 participantsStarted 2023-12-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Unwilling/unable to sign consent, * Severe cognitive impairment, * Severe COPD, * Anaemia, * Other life-threatening co-morbidity (in the opinion of the local co-investigator), * Known and active sarcoidosis or tuberculosis

What they're measuring

Combined heart failure hospitalisation and total mortality

Timeframe: 24 months

Trial details

NCT IDNCT03416361

SponsorUniversity of Leeds

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

Contact for this trial

Klaus K Witte, MD

k.k.witte@leeds.ac.uk

View on ClinicalTrials.gov More Chronic Heart Failure trials