Prospective Single-center Study Evaluating the Central Blood Pressure in Renal Transplantation

NCT ID: NCT02528591

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-12-31

Brief Summary

The renal transplant patient is at high cardiovascular risk compared to the general population. The cardiovascular mortality represents one of the most important causes of late graft loss. Cardiovascular risk prediction tools applied to the general population, however, are caught failing on the population of kidney transplant and tend to underestimate the actual risk.

Central blood pressure is the pressure imposed at large artery (aorta, carotid) and is directly related to the target organ (heart, kidney, brain). Central blood pressure could be a cardiovascular risk factor more robust and powerful than brachial blood pressure.

Central blood pressure may in part explain the increased risk of cardiovascular disease in the population of kidney transplant patients. A cohort of 250 kidney transplant patients will be constituted with a measure of concomitant central hemodynamic monitoring to the annual review will be conducted. The main objective of this study is to describe the central blood pressure measured by oscillometric method in renal transplanted population.

Conditions

Kidney Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

renal transplant patient

Group Type: EXPERIMENTAL

oscillometric device (Arteriograph®, Medexpert)

Intervention Type: DEVICE

Central blood pressure recorded in the non-fistula arm using a validated oscillometric device (Arteriograph®, Medexpert).

Interventions

oscillometric device (Arteriograph®, Medexpert)

Central blood pressure recorded in the non-fistula arm using a validated oscillometric device (Arteriograph®, Medexpert).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Major Patient
• Renal transplant patient

Exclusion Criteria

• Minor patient

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe MARIAT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Countries

France

Other Identifiers

2012-A01534-39

Identifier Type: OTHER

Identifier Source: secondary_id

1208159

Identifier Type: -

Identifier Source: org_study_id