Cardiovascular Diseases, Renal Failure, Vascular Calcification
Conditions
Keywords
Renal replacement therapy, Haemodialsysis, Calcification Inhibition Test
Brief summary
This pilot study aims to evaluate in an exploratory way the predictive power of a novel in vitro test (T50 Calcification Inhibition Test, T50 CIT), which measures the mineralization inhibition capacity of blood, in terms of its association with time to all-cause mortality in haemodialysis patients.
Detailed 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 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.
Interventions
DIAGNOSTIC_TESTT50 Calcification Inhibition Test (CIT)
Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients
Sponsors
Fresenius Medical Care Deutschland GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Exploratory, interventional, open, multi-center, prospective
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent signed and dated by study patient and investigator/authorised physician * Minimum age of 18 years * Incident and prevalent haemodialysis patients * Three haemodialysis treatments per week
Exclusion criteria
* Any condition which could interfere with the patient's ability to comply with the study * Pregnancy (pregnancy test will be conducted with female patients aged \<= 55 years) or lactation period * Participation in an interventional clinical study during the preceding 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T50 CIT values | Baseline after signed informed consent | The primary objective of this pilot study is to exploratory examine the predictive power of baseline T50 CIT values in terms of their association with time to all-cause mortality in haemodialysis patients. |
Countries
Spain
Outcome results
None listed