Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate

Study Overview
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Brief Summary
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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.

Official Title
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Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Procedure: Nephrectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney Donors<br> | Procedure: Nephrectomy<br>* Unilateral nephrectomy<br>|
| Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney donor