Congestive Heart Failure
Conditions
Keywords
vitamin D, mortality, event-free survival, heart failure
Brief summary
Despite significant therapeutic improvements, congestive heart failure (CHF) patients still have a poor prognosis. Currently, 5-year survival rates are only 35-50%. There is an accumulating body of evidence from prospective cohort studies that low circulating 25-hydroxyvitamin D is an independent predictor of all-cause and cardiovascular mortality, respectively. Vitamin D deficiency is prevalent among CHF patients. We hypothesize that vitamin D may improve survival in CHF patients. We therefore aimed to investigate whether vitamin D supplementation reduces mortality and increases event-free survival in end-stage CHF patients.
Interventions
DRUGVitamin D
daily oral vitamin D supplement of 100 micrograms for three years
DRUGplacebo
daily oral placebo supplement for three years
Sponsors
Heart and Diabetes Center North-Rhine Westfalia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* \> 18 years of age and \< 80 years of age * New York Heart Association Functional Class \> = II
Exclusion criteria
* pregnancy and lactation * sarcoidosis * daily vitamin D intake \> 20 micrograms * serum 25-hydroxyvitamin D \> 30 ng/ml * hypercalcemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who died during the intervention | three years | all-cause mortality (any cause of death) will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of event-free survivors | three years | event defined as: cardiac transplantation, high urgent listing for cardiac transplantation, resuscitation, ventricular assist device Implantation, hypercalcemia |
| Changes in biochemical risk markers | three years | inflammation markers, kidney parameters, lipid parameters, haemostasis parameters |
| Number of participants with elevated safety parameters | every 6 months | Serum 25-Hydroxyvitamin D should not exceed 150 ng/ml. Serum calcium should not exceed 2.75 mmol/l. |
Countries
Germany
Outcome results
None listed