VitamIN D Treating patIents With Chronic heArT failurE (VINDICATE)
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure
Eligibility 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)
Sites / Locations
- Leeds General Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin D
Placebo
Arm Description
Vitamin D 100mcg per day
Standard optimal therapy
Outcomes
Primary Outcome Measures
6 minute walk distance
Secondary Outcome Measures
Left ventricular function by Cardiac Magnetic Resonance
Peak exercise capacity
Biochemical changes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01619891
Brief Title
VitamIN D Treating patIents With Chronic heArT failurE
Acronym
VINDICATE
Official Title
VitamIN D Treating patIents With Chronic heArT failurE
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
This is a randomized placebo-controlled trial of vitamin D versus placebo in people with heart failure. Primary endpoint is 6 minute walk distance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
253 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
Vitamin D 100mcg per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Standard optimal therapy
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
100mcg per day
Primary Outcome Measure Information:
Title
6 minute walk distance
Time Frame
After one year
Secondary Outcome Measure Information:
Title
Left ventricular function by Cardiac Magnetic Resonance
Time Frame
At one year
Title
Peak exercise capacity
Time Frame
At one year
Title
Biochemical changes
Time Frame
At one year (but also throughout)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus K Witte, MD
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
27058906
Citation
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.
Results Reference
derived
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VitamIN D Treating patIents With Chronic heArT failurE
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