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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02528591
Other study ID # 1208159
Secondary ID 2012-A01534-39
Status Completed
Phase N/A
First received August 17, 2015
Last updated August 18, 2015
Start date March 2013
Est. completion date December 2014

Study information

Verified date August 2015
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Major Patient

- Renal transplant patient

Exclusion Criteria:

- Minor patient

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHU de SAINT-ETIENNE Saint-etienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary central blood pressure Baseline No
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