Ireland
--:--IST
Active, not recruiting Observational

Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate

NCT03729557 · tracked via the Priya Life Science Norway tracker
Phase
Observational
Started
2019-02-01
Last updated
2025-08-22

Condition(s) studied

Cardiovascular Diseases

Investigational drug(s) / intervention(s)

Nephrectomy

Nephrectomy: Unilateral nephrectomy

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
* 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 outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Oslo University Hospital Oslo Norway
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03729557 on ClinicalTrials.gov ↗ ← All trials in Norway