VitamIN D Treating patIents With Chronic heArT failurE (VINDICATE)

October 25, 2016 updated by: KK Witte, University of Leeds
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized placebo-controlled trial of vitamin D versus placebo in people with heart failure. Primary endpoint is 6 minute walk distance.

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D
Vitamin D 100mcg per day
Dietary supplement: Vitamin D
100mcg per day
Placebo Comparator: Placebo
Standard optimal therapy
Dietary supplement: Vitamin D
100mcg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6 minute walk distance
Time Frame: After one year
After one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Left ventricular function by Cardiac Magnetic Resonance
Time Frame: At one year
At one year
Peak exercise capacity
Time Frame: At one year
At one year
Biochemical changes
Time Frame: At one year (but also throughout)
At one year (but also throughout)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Investigators

  • Principal Investigator: Klaus K Witte, MD, University of Leeds

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (Estimate)

June 14, 2012

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR/J00281X/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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