NCT01619891

Brief Summary

Despite recent advances and even when receiving optimal therapy, patients with chronic heart failure (CHF) suffer poor quality of life, with recurrent hospitalisations and persistent symptoms. The investigators have shown that patients attending the Leeds Integrated Heart Failure Service are also frequently deficient in vitamin D and that the severity of the deficiency relates to the levels of symptoms, exercise capacity, diuretic requirements and response to optimal medical therapy. Vitamin D contributes to cardiac and skeletal muscle contractile function, immune function, pancreatic insulin release, and neuro-hormonal homeostasis. A randomised, placebo-controlled proof of concept study in 60 CHF patients has demonstrated improvements in submaximal exercise capacity and symptoms. VINDICATE will be a randomised, placebo-controlled developmental clinical study in 250 patients with CHF and vitamin D deficiency. The present study is designed to detect whether vitamin D has pathophysiologically important effects, as well as providing preliminary evidence of efficacy and safety by examining cardiac function (using cardiac magnetic resonance imaging) and submaximal exercise capacity (by 6-minute walk test). This will provide pertinent data to inform a larger multi-centre efficacy and effectiveness study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

3.2 years

First QC Date

June 12, 2012

Last Update Submit

October 25, 2016

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 6 minute walk distance

    After one year

Secondary Outcomes (3)

  • Left ventricular function by Cardiac Magnetic Resonance

    At one year

  • Peak exercise capacity

    At one year

  • Biochemical changes

    At one year (but also throughout)

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Vitamin D 100mcg per day

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

Standard optimal therapy

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT

100mcg per day

PlaceboVitamin D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Class II or III CHF
  • Stable symptoms (on otherwise optimally tolerated medical therapy)
  • Able to give written informed consent

You may not qualify if:

  • Currently taking vitamin D supplementation
  • Untreated valvular heart disease
  • Existing class I indication for vitamin D therapy
  • History of primary hyperparathyroidism, tuberculosis, sarcoidosis, malignancy or hypercalcaemia
  • Heart failure due to anaemia or thyrotoxicosis
  • Renal failure (GFR \<30l/min)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

Location

Related Publications (1)

  • Witte KK, Byrom R, Gierula J, Paton MF, Jamil HA, Lowry JE, Gillott RG, Barnes SA, Chumun H, Kearney LC, Greenwood JP, Plein S, Law GR, Pavitt S, Barth JH, Cubbon RM, Kearney MT. Effects of Vitamin D on Cardiac Function in Patients With Chronic HF: The VINDICATE Study. J Am Coll Cardiol. 2016 Jun 7;67(22):2593-603. doi: 10.1016/j.jacc.2016.03.508. Epub 2016 Apr 4.

    PMID: 27058906DERIVED

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Klaus K Witte, MD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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

June 12, 2012

First Posted

June 14, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Locations

GB(1)