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Clinical Trials/NCT03729557
NCT03729557
Active, not recruiting
Not Applicable

Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate

Oslo University Hospital1 site in 1 country109 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Oslo University Hospital
Enrollment
109
Locations
1
Primary Endpoint
Change in left ventricular mass.
Status
Active, not recruiting
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
January 1, 2029
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Jon Arne Birkeland

Principal investigator, Medical doctor, PhD

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Persons who do not meet the Norwegian donor criteria.

Outcomes

Primary Outcomes

Change in left ventricular mass.

Time Frame: 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.

Time Frame: 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 Outcomes

  • 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.)
  • 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.)

Study Sites (1)

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