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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
daily oral vitamin D supplement of 100 micrograms for three years
daily oral placebo supplement for three years
Heart Center North Rhine-Westphalia
Bad Oeynhausen, Federal State of North Rhine-Westphalia, Germany
Number of participants who died during the intervention
all-cause mortality (any cause of death) will be assessed
Time frame: three years
Number of event-free survivors
event defined as: cardiac transplantation, high urgent listing for cardiac transplantation, resuscitation, ventricular assist device Implantation, hypercalcemia
Time frame: three years
Changes in biochemical risk markers
inflammation markers, kidney parameters, lipid parameters, haemostasis parameters
Time frame: three years
Number of participants with elevated safety parameters
Serum 25-Hydroxyvitamin D should not exceed 150 ng/ml. Serum calcium should not exceed 2.75 mmol/l.
Time frame: every 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.