Clinical trial NCT03729557: Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate
Official title: Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Diseases
Keywords: Kidney donor
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
name: University of Oslo
First posted: 2018-11-02
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: * Donor Group: persons selected as living kidney donors according to the Norwegian donor criteria and accepted for surgery at Rikshospitalet, Norway
* Control Group: persons fulfilling the criteria according to the Norwegian transplantation protocol for living kidney donors with one exeption: they do not have to be investigated with CT angiography which is not considered necessary.

Exclusion Criteria:

• Persons who do not meet the Norwegian donor criteria.

Primary outcomes:
measure: Change in left ventricular mass.
timeFrame: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
measure: Change in left ventricular strain.
timeFrame: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Secondary outcomes:
measure: Change in arterial pulse wave velocity.
timeFrame: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
measure: Change in intima and media thickness of aorta.
timeFrame: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
measure: Change in the calsium/phosphate homeostasis.
timeFrame: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
measure: Change in inflammation-marker.
timeFrame: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Jon Arne Birkeland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blom 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.