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

Kidney Transplant Clinical Trial

— PACT  

Official title:

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

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

• Kidney Transplant

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