Study of the Renal Perfusion in Healthy Volunteers and Renal Transplant Recipients During an Orthostatic Stress (ortho_rein)

University Hospital, Angers

Status: Completed

Conditions: Kidney Transplant Recipients; Safe Volunteers

Treatments: Other: tilt test

Study type: Interventional

Funder types: Other

Identifiers

NCT02179411

CHU-P2009-01

Details and patient eligibility

About

Autonomic nervous system contributes to the regulation of renal blood flow, affected by upright posture. Kidney transplantation implies sympathetic denervation. The aim of this study is to compare the renal vascular response in volunteers and renal graft recipients to an orthostatic stress induced by a head-up tilt test. Renal peripheral resistances are assessed by echo Doppler. The sympathetic nervous system activity is evaluated by plasma concentrations of catecholamine before and after the head-up tilt test.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers Male or female, within 18 and 50 year old Caucasian type

No cardiovascular risk factor:

Body mass index below 25 kg/m2 No smoking No dyslipidemia No diabetes No kidney disease or chronic renal failure No medication Electrocardiogram: normal Arterial blood pressure: normal Plasma creatinine clearance equivalent to 50mL/min or more (Cockroft formula) No proteinuria and no hematuria Able to understand the purpose of the study and sign the informed consent

• Renal graft recipients Male or female, within 18 and 50 year old Caucasian type About a year after the first renal allograft Body mass index below 25 kg/m2 No smoking No dylipidemia No diabetes Arterial blood pressure controlled Electrocardiogram: normal Plasma creatinine clearance equivalent to 50mL/min or more (Cockroft formula) Able to understand the purpose of the study and sign the informed consent

Exclusion criteria

• Healthy volunteers Creatinine clearance < 50 mL/min (Cockroft formula) More than 2 syncopes a year Pregnancy
• Renal graft recipients Creatinine clearance < 50 mL/min (Cockroft formula) Second renal allograft or more More than 3 antihypertensive treatments Beta adrenoreceptors blockers Acute rejection More than 2 syncopes a year

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

healthy volunteers

Active Comparator group

Description:

healthy volunteers

Treatment:

Other: tilt test

renal transplant recipients

Active Comparator group

Description:

renal transplant recipients

Treatment:

Other: tilt test

renal transplant recipients grave

Active Comparator group

Description:

renal transplant recipients grave

Treatment:

Other: tilt test