Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03729557

Acronym

CENS

Enrollment

109

Registered

2018-11-02

Start date

2019-02-01

Completion date

2029-01-01

Last updated

2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

Kidney donor

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.

Interventions

PROCEDURENephrectomy

Unilateral nephrectomy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Change in left ventricular mass.	Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.	Cardiac magnetic resonance imaging (CMRI) and echocardiography.
Change in left ventricular strain.	Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.	CMRI and echocardiography.

Secondary

Measure	Time frame	Description
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.	CMRI
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.	CMRI Inflammation: biomarkers.
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.	DXA-scan.
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.	Biomarker: high sensitive CRP

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026