Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate

Cardiovascular Diseases Clinical Trial

— CENS  

Official title:

Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03729557
• Other study ID #: 2016/1961
• Status: Active, not recruiting
• Start date: February 1, 2019
• Est. completion date: January 1, 2029

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 109
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Procedure:
• Nephrectomy
Unilateral nephrectomy

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	South-Eastern Norway Regional Health Authority, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Change in arterial pulse wave velocity.	CMRI	Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Secondary	Change in intima and media thickness of aorta.	CMRI Inflammation: biomarkers.	Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Secondary	Change in the calsium/phosphate homeostasis.	DXA-scan.	Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Secondary	Change in inflammation-marker.	Biomarker: high sensitive CRP	Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.