Skip to main content
OpenTrials
Completed

NCT Number: NCT01619891

VitamIN D Treating patIents With Chronic heArT failurE

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitamin D

Dietary Supplement

100mcg per day

Primary outcomes

  1. 6 minute walk distance

    Time frame: After one year

Secondary outcomes

  1. Left ventricular function by Cardiac Magnetic Resonance

    Time frame: At one year

  2. Peak exercise capacity

    Time frame: At one year

  3. Biochemical changes

    Time frame: At one year (but also throughout)

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Registry information

Acronym: VINDICATE

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jun 14, 2012
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.