VitamIN D Treating patIents With Chronic heArT failurE (VINDICATE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
KK Witte, University of Leeds
ClinicalTrials.gov Identifier:
NCT01619891
First received: June 12, 2012
Last updated: December 1, 2015
Last verified: December 2015

June 12, 2012
December 1, 2015
August 2012
October 2015   (final data collection date for primary outcome measure)
6 minute walk distance [ Time Frame: After one year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Peak exercise capacity [ Time Frame: At one year ] [ Designated as safety issue: No ]
  • Biochemical changes [ Time Frame: At one year (but also throughout) ] [ Designated as safety issue: Yes ]
  • LV function by CMR [ Time Frame: At one year ] [ Designated as safety issue: No ]
  • Peak exercise capacity [ Time Frame: At one year ] [ Designated as safety issue: No ]
  • Biochemical changes [ Time Frame: At one year (but also throughout) ] [ Designated as safety issue: Yes ]
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 an RCT of vitmain D versus placebo in people with heart failure. Primary endpoint is 6 minute walk distance.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
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)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01619891
MR/J00281X/1
Yes
Not Provided
Not Provided
KK Witte, University of Leeds
University of Leeds
Not Provided
Principal Investigator: Klaus K Witte, MD University of Leeds
University of Leeds
December 2015

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