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VitamIN D Treating patIents With Chronic heArT failurE

NCT ID: NCT01619891

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-01-31

Brief Summary

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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

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This is a randomized placebo-controlled trial of vitamin D versus placebo in people with heart failure. Primary endpoint is 6 minute walk distance.

Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D

Vitamin D 100mcg per day

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

100mcg per day

Placebo

Standard optimal therapy

Group Type PLACEBO_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

100mcg per day

Interventions

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Vitamin D

100mcg per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leeds

OTHER

Sponsor Role lead

Responsible Party

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KK Witte

Senior Lecturer in Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus K Witte, MD

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

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Leeds General Infirmary

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 27058906 (View on PubMed)

Other Identifiers

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MR/J00281X/1

Identifier Type: -

Identifier Source: org_study_id