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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02179411
Acronym
ortho_rein
Enrollment
60
Registered
2014-07-01
Start date
2009-04-30
Completion date
2013-03-31
Last updated
2014-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Recipients, Safe Volunteers

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.

Interventions

Sponsors

National Research Agency, France
CollaboratorOTHER
University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of vascular resistance standing in renal transplant subjects compared with healthy subjects.three yearsEvaluation of vascular resistance standing in renal transplant subjects compared with healthy subjects.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026