The goal of this study is to evaluate if serum FGF23 levels are directly related to cardiovascular calcification, measured as arterial stiffness with pulse wave velocity. The primary objective is to evaluate if elevated serum FGF23 and decreased…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum FGF23, Klotho and vitamin D concentrations and their correlation with
arterial stiffness as measured by pulse wave velocity.
Secondary outcome
Correlation between carotid-femoral pulse wave velocity (cfPWV) and
WeSTElan-derived PWV (wePWV).
Background summary
Vascular calcification and arterial stiffness, precipitated by abnormal calcium
and phosphate metabolism in CKD, are related to the high cardiovascular
mortality in chronic kidney disease (CKD) patients1-3. High Fibroblast Growth
Factor (FGF)23 levels are associated with endothelial dysfunction, direct toxic
effects to the cardiac myocytes leading to left ventricular hypertrophy and
higher risk of cardiovascular events 4-7. The effects of elevated FGF23 levels
on vascular calcification remains controversial 8, 9.
Study objective
The goal of this study is to evaluate if serum FGF23 levels are directly
related to cardiovascular calcification, measured as arterial stiffness with
pulse wave velocity. The primary objective is to evaluate if elevated serum
FGF23 and decreased klotho and vitamin D (25 (OH)D) concentrations are related
to increased arterial stiffness as measured by a carotid-femoral pulse wave
velocity meter in patients with chronic kidney disease.
As a secondary objective, the study assesses correspondence between pulse wave
velocity estimated from skin reflectivity (photoplethysmogram, PPG) and
acceleration data simultaneously acquired at wrist, ankle and torso and pulse
wave velocity obtained using a carotid-femoral pulse wave velocity meter.
Study design
Cross-sectional single center study.
Study burden and risks
Patients visit the out-patient clinic for routine check-up including their
regular blood sample drawn, which we will use to measure FGF23, klotho and
vitamin D concentrations. During this same appointment, patients undergo a
single lead ECG measurement , a carotid-femoral pulse wave velocity measurement
(cfPWV) and skin reflectivity (PPG) and acceleration measurements at wrist,
ankle and torso.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
Participating in the (pre)dialysis program
Informed consent.
Exclusion criteria
Age below 18 years.
Withdrawal of consent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL54602.100.17 |