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

Not Applicable

Completed

• Conditions: Safe Volunteers; Kidney Transplant Recipients
• Interventions: Other: tilt test

• Registration Number: NCT02179411
• Lead Sponsor: University Hospital, Angers

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-04
• Study Start: 2009-04
• Primary Completion: 2009-04
• Study Completion: 2013-03
• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-06-27
• Last Update Submitted: 2014-06-27
• Study First Posted: 2014-07-01
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy volunteers	tilt test	healthy volunteers
renal transplant recipients	tilt test	renal transplant recipients
renal transplant recipients grave	tilt test	renal transplant recipients grave

Primary Outcome Measures

Name	Time	Method
Evaluation of vascular resistance standing in renal transplant subjects compared with healthy subjects.	three years	Evaluation of vascular resistance standing in renal transplant subjects compared with healthy subjects.

Trial Locations

Locations (1)

CHU d'Angers; 🇫🇷 Angers, France