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VitamIN D Treating patIents With Chronic heArT failurE (VINDICATE)

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ClinicalTrials.gov Identifier: NCT01619891
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):

June 12, 2012
June 14, 2012
October 26, 2016
August 2012
October 2015   (Final data collection date for primary outcome measure)
6 minute walk distance [ Time Frame: After one year ]
Same as current
Complete list of historical versions of study NCT01619891 on ClinicalTrials.gov Archive Site
  • Left ventricular function by Cardiac Magnetic Resonance [ Time Frame: At one year ]
  • Peak exercise capacity [ Time Frame: At one year ]
  • Biochemical changes [ Time Frame: At one year (but also throughout) ]
  • LV function by CMR [ Time Frame: At one year ]
  • Peak exercise capacity [ Time Frame: At one year ]
  • Biochemical changes [ Time Frame: At one year (but also throughout) ]
Not Provided
Not Provided
VitamIN D Treating patIents With Chronic heArT failurE
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.
This is a randomized placebo-controlled trial of vitamin D versus placebo in people with heart failure. Primary endpoint is 6 minute walk distance.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Heart Failure
Dietary Supplement: Vitamin D
100mcg per day
  • Active Comparator: Vitamin D
    Vitamin D 100mcg per day
    Intervention: Dietary Supplement: Vitamin D
  • Placebo Comparator: Placebo
    Standard optimal therapy
    Intervention: Dietary Supplement: Vitamin D
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2016
October 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
Plan to Share IPD: Yes
KK Witte, University of Leeds
University of Leeds
Not Provided
Principal Investigator: Klaus K Witte, MD University of Leeds
University of Leeds
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP