The Role of Vitamin D in the Pathophysiology of Chronic Failure

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients will undergo at baseline and regular intervals:

• clinically indicated bloodwork/urine and echocardiogram testing

• biomarker studies

Upon enrolment in the study patients will be divided into 4 groups normal, mildly deficient and severely deficient. Normal and mild vitamin D levels will receive no treatment while severe Vitamin D deficiency will be randomized (50/50) to receive no treatment or vitamin D treatment. They will be seen in the heart failure clinic every 6 months. The patients will be followed for 26 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• an ejection fraction (EF) ≤40% within the last 12 months before recruitment

• established diagnosis of heart failure

• >18 years of age

• patients with Vitamin D levels of sufficient, mild deficiency and severe deficiency

Exclusion Criteria:

• hypercalcemia

• known hypersensitivity to Vitamin D

• patient unwilling to comply with study requirements

• any other disease other than heart failure that can alter the patients quality of life over a period of 6 months

• women of child bearing potential

• a patient currently taking vitamin d

• severe renal impairment eGFR <30