The main objective is to validate serum calcification propensity as a read-out for vascular calcification and the secondary objective is to identify determinants of vascular calcification (progression).
ID
Source
Brief title
Condition
- Other condition
- Coronary artery disorders
- Bone, calcium, magnesium and phosphorus metabolism disorders
Synonym
Health condition
niertransplantatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the association between baseline serum
calcification propensity and the relative change in the CAC score over a
two-year period.
Secondary outcome
To identify endogenous and exogenous determinants of CAC-score (progression)
and calcification propensity information on age, sex, medical history, duration
of pre transplantation dialysis, lifestyle factors including detailed nutrition
data and physical activity, use of medication, physical data (including blood
pressure and body mass index), and biochemical data, including blood and 24-h
urine samples will be collected as part of routine TransplantLines procedures.
From the samples collected and stored by TransplantLines, we will analyse
parameters of vitamin K status (e.g., nonphosphorylated-uncarboxylated [dp-uc]
MGP), parameters of mineral metabolism (i.e., serum phosphate, calcium,
albumin, magnesium, PTH, and FGF23), lipid profile, renal function and albumin
excretion/24h.
Background summary
Traditional cardiovascular risk factors only partly explain the increased
cardiovascular disease (CVD) risk after kidney transplantation. Emerging data
suggest that vascular calcification plays a significant role in the aetiology
of CVD in this population. The potential of specific interventions to target
vascular calcification in renal transplant recipients has barely been explored.
Therefore the identification of modifiable key factors driving vascular
calcification is needed to provide novel treatment targets able to retard or
arrest vascular calcification progression after kidney transplantation.
Studying vascular calcification is limited by the drawback that most current
techniques assess prevalent calcification, requiring expensive, repeated
measurements with a considerable interval. Importantly, a serum test was
recently developed that quantifies the tendency to develop new vascular
calcifications in contrast to prevalent calcifications. The hypothesis
addressed in this project is that serum calcification propensity is a predictor
of coronary artery calcification progression.
Study objective
The main objective is to validate serum calcification propensity as a read-out
for vascular calcification and the secondary objective is to identify
determinants of vascular calcification (progression).
Study design
A prospective, single-centre, longitudinal, observational study among 250 renal
transplant recipients. This study will be performed in the context of the
TransplantLines biobanking project.
Study burden and risks
Ultra-low-dose CT scans of the heart will be performed. The total study related
radiation dose as calculated by the radiation expert will be 1.2 mSv. These
dose ranges fit very well within the radiation dose limits for population
imaging as defined by the Gezondheidsraad. Radiodiagnostic technicians will
perform and radiologists will evaluate the CT scans. There are no adverse
events expected during the collection of the CT scans.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1. Age >=18 years
2. Male and female renal transplant recipients
3. Participant of TransplantLines
4. 6-12 months post kidney transplantation
5. eGFR > 30 ml/min/1.73m2
6. Signed informed consent
Exclusion criteria
1. Life-expectancy < 2 years
2. Active malignancy; exception treated basal cell or squamous cell carcinoma
3. Known pregnancy
Design
Recruitment
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 | NL64539.042.17 |
| Other | TC = 7105 (NTR) |