VitamIN D Treating patIents With Chronic heArT failurE

Chronic Heart Failure Clinical Trial

— VINDICATE  

Official title:

VitamIN D Treating patIents With Chronic heArT failurE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619891
• Other study ID #: MR/J00281X/1
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2012
• Last updated: October 25, 2016
• Start date: August 2012
• Est. completion date: January 2016

Study information

• Verified date: October 2016
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Dietary Supplement:
• Vitamin D
100mcg per day

Locations

Country	Name	City	State
United Kingdom	Leeds General Infirmary	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk distance		After one year
Secondary	Left ventricular function by Cardiac Magnetic Resonance		At one year
Secondary	Peak exercise capacity		At one year
Secondary	Biochemical changes		At one year (but also throughout)