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

NCT02179411 | Completed DMC

• 1 other identifier: CHU-P2009-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Safe Volunteers; Kidney Transplant Recipients

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

healthy volunteers

ACTIVE COMPARATOR

healthy volunteers

Other: tilt test

renal transplant recipients

ACTIVE COMPARATOR

renal transplant recipients

Other: tilt test

renal transplant recipients grave

ACTIVE COMPARATOR

renal transplant recipients grave

Other: tilt test

Interventions

tilt test OTHER

healthy volunteers; renal transplant recipients; renal transplant recipients grave

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead
• National Research Agency, France: collaborator

Study Sites (1)

CHU d'Angers

Angers, 49933, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 1, 2014
• Study Start: April 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: March 1, 2013
• Last Updated: July 1, 2014

Record last verified: 2009-04

Locations

FR (1)