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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplant Recipients; Safe Volunteers
• Intervention / Treatment: Other: tilt test

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU d'Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: healthy volunteers	Other: tilt test
Active Comparator: renal transplant recipients	Other: tilt test
Active Comparator: renal transplant recipients grave	Other: tilt test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of vascular resistance standing in renal transplant subjects compared with healthy subjects.	Evaluation of vascular resistance standing in renal transplant subjects compared with healthy subjects.	three years

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: National Research Agency, France

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: June 27, 2014
• First Posted (Estimate): July 1, 2014

Study Record Updates

• Last Update Posted (Estimate): July 1, 2014
• Last Update Submitted That Met QC Criteria: June 27, 2014
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: CHU-P2009-01