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

NCT03416361 | Not Yet Recruiting DMC

• 1 other identifier: 224168
• Study Type: interventional
• Target: 1,253
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Heart Failure

Keywords

Left ventricular dysfunction; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Combined heart failure hospitalisation and total mortality

  Time to death or first hospitalisation for heart failure

  24 months

Secondary Outcomes (3)

• Total mortality

  24 months

• Cost effectiveness

  24 months

• Change in patient quality of life

  24 months

Study Arms (2)

Vitamin D

EXPERIMENTAL

4000IU Vitamin D3 as two 50mcg tablets per day

Dietary Supplement: 4000IU Vitamin D3

Control

PLACEBO COMPARATOR

Placebo - two chewable blackcurrant flavoured tablets per day

Dietary Supplement: 4000IU Vitamin D3

Interventions

4000IU Vitamin D3 DIETARY_SUPPLEMENT

Chewable blackcurrant flavoured tablets (two per day)

Control; Vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LVSD (LVEF \<50%);
• stable medical and device therapy for \>3mths;
• \[OH\]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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Leeds General Infirmary

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Klaus K Witte, MD

CONTACT

k.k.witte@leeds.ac.uk

Klaus Witte

CONTACT

00441133926642

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Cardiology

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: January 31, 2018
• Study Start: December 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)