Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate
CENS
1 other identifier
observational
109
1 country
1
Brief Summary
Chronic kidney disease (CKD) is highly frequent, and patients with advanced CKD are known to have a high risk of developing cardiovascular disease (CVD). However, little is known about the cardiovascular risk in patients with mildly reduced kidney function (reduced glomerular filtration rate, GFR), affecting up to 10% of the general population; and importantly, also affecting living kidney donors. Until recently it has been believed that donating a kidney does not represent any health hazard. However, a recent Norwegian epidemiological study suggested that kidney donors have an increased risk of CVD. The pathogenesis linking reduced kidney function to CVD is not known. Living kidney donors provide a unique model for investigating the mechanisms underlying increased risk of CVD in patients with reduced GFR because living kidney donors are healthy before donation. Thus, the main purpose of the Project is to investigate the mekanismes underlying the development of cardiovascular remodelling induced by a reduction in GFR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2018
CompletedFirst Posted
Study publicly available on registry
November 2, 2018
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
August 22, 2025
August 1, 2025
9.9 years
October 10, 2018
August 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in left ventricular mass.
Cardiac magnetic resonance imaging (CMRI) and echocardiography.
Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Change in left ventricular strain.
CMRI and echocardiography.
Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Secondary Outcomes (4)
Change in arterial pulse wave velocity.
Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Change in intima and media thickness of aorta.
Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Change in the calsium/phosphate homeostasis.
Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Change in inflammation-marker.
Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Study Arms (2)
Kidney Donors
Control group
Interventions
Eligibility Criteria
The project is a prospective longitudinal parallel group study including persons selected as living kidney donors according to the Norwegian donor criteria and accepted for surgery at Rikshospitalet, Norway. The donors will be compared to a control group consisting of individuals evaluated for donation, but not found eligible and healthy family members related to donors. The control individuals will be age and sex matched to living kidney donors. Control individuals who accept to participate will go through the same test battery (the Norwegian transplantation protocol for living kidney donors) as living kidney donors and must fulfil these criteria before inclusion as controls.
You may not qualify if:
- Persons who do not meet the Norwegian donor criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- South-Eastern Norway Regional Health Authoritycollaborator
- University of Oslocollaborator
Study Sites (1)
Oslo University Hospital
Oslo, Norway
Related Publications (2)
Brobak KM, Halvorsen LV, Aass HCD, Soraas CL, Aune A, Olsen E, Bergland OU, Rognstad S, Blom KB, Birkeland JAK, Hoieggen A, Larstorp ACK, Solbu MD. Novel biomarkers in patients with uncontrolled hypertension with and without kidney damage. Blood Press. 2024 Dec;33(1):2323980. doi: 10.1080/08037051.2024.2323980. Epub 2024 Apr 12.
PMID: 38606688DERIVEDBlom KB, Bergo KK, Espe EKS, Rosseland V, Grotta OJ, Mjoen G, Asberg A, Bergan S, Sanner H, Bergersen TK, Bjornerheim R, Skauby M, Seljeflot I, Waldum-Grevbo B, Dahle DO, Sjaastad I, Birkeland JA. Cardiovascular rEmodelling in living kidNey donorS with reduced glomerular filtration rate: rationale and design of the CENS study. Blood Press. 2020 Apr;29(2):123-134. doi: 10.1080/08037051.2019.1684817. Epub 2019 Nov 13.
PMID: 31718316DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Arne Birkeland, MD, PhD
Oslo University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator, Medical doctor, PhD
Study Record Dates
First Submitted
October 10, 2018
First Posted
November 2, 2018
Study Start
February 1, 2019
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Last Updated
August 22, 2025
Record last verified: 2025-08