Status:
NOT_YET_RECRUITING
VItamiN D treatIng Chronic heArT Failure (the Effect of Vitamin D Supplementation in Patients With Heart Failure)
Lead Sponsor:
University of Leeds
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 deficien...
Detailed Description
DESIGN: Multi-centre, phase III, double-blind, parallel-group, placebo-controlled trial. SETTING: Secondary care heart failure clinics across the UK. TARGET POPULATION: Higher-risk patients with CHF ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
1253 Patients enrolled
Trial Details
Trial ID
NCT03416361
Start Date
December 1 2023
End Date
March 1 2027
Last Update
November 2 2022
Active Locations (1)
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1
Leeds General Infirmary
Leeds, United Kingdom