VitamIN D Treating patIents With Chronic heArT failurE (VINDICATE)

This study is currently recruiting participants.
Verified March 2013 by University of Leeds
Sponsor:
Information provided by (Responsible Party):
KK Witte, University of Leeds
ClinicalTrials.gov Identifier:
NCT01619891
First received: June 12, 2012
Last updated: March 24, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Chronic Heart Failure
Dietary Supplement: Vitamin D
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: VitamIN D Treating patIents With Chronic heArT failurE

Resource links provided by NLM:


Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • 6 minute walk distance [ Time Frame: After one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619891

Contacts
Contact: Klaus K Witte, MD k.k.witte@leeds.ac.uk

Locations
United Kingdom
Hull University Active, not recruiting
Kingston-upon-Hull, United Kingdom, HU1
Leeds General Infirmary Recruiting
Leeds, United Kingdom, LS1 3EX
Principal Investigator: Klaus K Witte, MD         
Sponsors and Collaborators
University of Leeds
Investigators
Principal Investigator: Klaus K Witte, MD University of Leeds
  More Information

No publications provided

Responsible Party: KK Witte, Senior Lecturer in Cardiology, University of Leeds
ClinicalTrials.gov Identifier: NCT01619891     History of Changes
Other Study ID Numbers: MR/J00281X/1
Study First Received: June 12, 2012
Last Updated: March 24, 2013
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014