Chronic Heart Failure, Vitamin D Deficiency
Conditions
Brief 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.
Detailed description
The inclusion criteria for the study is: * an EF ≤40% within the last 12 months before recruitment * established diagnosis of heart failure * \>18 years of age * patients will vitamin d levels of sufficient, mild deficiency and severe deficiency The exclusion criteria is: * 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 estimated glomerular filtration rate (eGFR) \<30
Interventions
DRUGVitamin D
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of Vitamin D deficiency amongst chronic heart failure patients at the University of Ottawa Heart Institute | up to 3 years | The primary outcome for the study is to identify the prevalence of Vitamin D deficiency amongst chronic heart failure patients followed at the University of Ottawa Heart Institute. This will be done analyzing the Vitamin D blood levels at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To demonstrate that Vitamin D deficiency is associated with poor outcome and that Vitamin D supplementation can be of clinical benefit | up to 3 years | clinical endpoints of: hospitalizations for worsening congestive heart failure, death will be compared for severe Vitamin D deficient patients receiving Vitamin D supplementation vs severe Vitamin D deficient patients receiving no intervention |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORHaissam Haddad
The University of Ottawa Heart Insitute
Outcome results
None listed