NCT03416361Not yet recruiting
VItamiN D treatIng Chronic heArT Failure (the Effect of Vitamin D Supplementation in Patients With Heart Failure)
VItamiN D treatIng Chronic heArT Failure (the Effect of Vitamin D Supplementation on Hospitalisation and Mortality in Patients With Heart Failure): Multicentre, Phase III, Randomised Placebo-controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1253 (estimated)
- First submitted
- 4 Dec 2017
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- University of Leeds
- Diseases
- Heart failure
- NCT number
- NCT03416361
What you commit to
- Study type: Interventional
- Planned participants: 1253
- From 1 Dec 2023 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe cognitive impairment,
- Known and active sarcoidosis or tuberculosis
Other
- Unwilling/unable to sign consent,
- Severe COPD,
- Anaemia,
- Other life-threatening co-morbidity (in the opinion of the local co-investigator),
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leeds General Infirmary Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.