Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cardiovascular Diseases
  • Renal Failure
  • Vascular Calcification
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Exploratory, interventional, open, multi-center, prospectiveMasking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Disturbances in mineral and bone metabolism centrally contribute to the exceedingly elevated risk for cardiovascular (CV) disease in dialysis patients. A novel in vitro test (T50 Calcification Inhibition Test, T50 CIT) has been developed, which measures the mineralization inhibition capacity of bloo...

Disturbances in mineral and bone metabolism centrally contribute to the exceedingly elevated risk for cardiovascular (CV) disease in dialysis patients. A novel in vitro test (T50 Calcification Inhibition Test, T50 CIT) has been developed, which measures the mineralization inhibition capacity of blood. This pilot study aims to exploratory examine the predictive power of baseline T50 CIT and fetuin-A (protein which is centrally involved in the inhibition of the formation of crystalline hydroxyapatite) values in terms of their association with all-cause mortality in an unselected cohort of haemodialysis patients. Moreover, the study shall investigate the association between baseline T50 CIT and fetuin-A values with CV related mortality, all-cause hospitalization and CV related hospitalization. Finally, the study aims to compare the predictive power of T50 CIT values with a set of six established calcification-related parameters (albumin, phosphate, calcium, magnesium, bicarbonate and fetuin-A). After baseline blood sampling the patients will be followed for 2 years.

Tracking Information

NCT #
NCT03292029
Collaborators
Not Provided
Investigators
Principal Investigator: Rosa Ramos, Dr. Fresenius Medical Care Spain, Country Medical Director