No registrations found.
ID
Source
Brief title
Health condition
Renal transplant recipients; vascular calcification; serum calcification propensity; coronary artery calcification progression.
Niertransplantatie-ontvangers; vasculaire calcificatie; serum verkalkingstendens; CT-calcium score.
Sponsors and support
Dutch Kidney Foundation
Intervention
Outcome measures
Primary outcome
To validate serum calcification propensity as a read-out for change in vascular calcification, measured as CT-based coronary artery calcification score, in renal transplant recipients.
Secondary outcome
Identify determinants of vascular calcification (progression) in renal transplant recipients; classical cardiovascular risk factors, mineral metabolism factors, calcification inhibitors and dietary factors.
Background summary
Rationale: 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.
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. This study will be performed in the context of the TransplantLines biobanking project.
Study population: Renal transplant recipients, 6-12 months post kidney transplantation, of ≥18 years who participate in TransplantLines and have a renal function (eGFR) of > 30 ml/min/1.73m2, are eligible for this study. Exclusion criteria are: life-expectancy < 2 years, active malignancy (exception treated basal cell or squamous cell carcinoma), and known pregnancy. We aim to include 250 participants.
Intervention (if applicable): All participants will undergo ultra-low-dose CT scanning and pulse wave velocity measurement in addition to the TransplantLines protocol.
Main study parameters/endpoints: 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.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.
Zie ook de website https://www.umcg.nl/NL/UMCG/Afdelingen/Transplantatiecentrum/onderzoek/transplantlines/Paginas/default.aspx
Study objective
The hypothesis addressed in this project is that serum calcification propensity is a predictor of coronary artery calcification progression.
Study design
Follow-up of two years
Intervention
All participants will undergo ultra-low-dose CT scanning and pulse wave velocity measurement in addition to the TransplantLines protocol.
[default]
The Netherlands
(050) 361 97 10
[default]
The Netherlands
(050) 361 97 10
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 |
|---|---|
| NTR-new | NL6910 |
| NTR-old | NTR7105 |
| Other | METc UMCG : 2017/671 |