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: May 26, 2015
Last verified: May 2015
  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: October 2015
Estimated Primary Completion Date: October 2015 (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

Detailed Description:

This is an RCT of vitmain D versus placebo in people with heart failure. Primary endpoint is 6 minute walk distance.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619891

Locations
United Kingdom
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
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: May 26, 2015
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on July 30, 2015