Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate

Active, not recruiting

• Conditions: Cardiovascular Diseases
• Interventions: Procedure: Nephrectomy

• Registration Number: NCT03729557
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-02
• Study Start: 2019-02-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-02
• Primary Completion: 2025-01-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

Not provided

Exclusion Criteria

• Persons who do not meet the Norwegian donor criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney Donors	Nephrectomy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway