NCT02528591

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

August 17, 2015

Last Update Submit

August 18, 2015

Conditions

Kidney Transplant

Keywords

patientrenal transplant

Outcome Measures

Primary Outcomes (1)

  • central blood pressure

    Baseline

Study Arms (1)

renal transplant patient

EXPERIMENTAL
Device: oscillometric device (Arteriograph®, Medexpert)

Interventions

oscillometric device (Arteriograph®, Medexpert)DEVICE

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

renal transplant patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major Patient
  • Renal transplant patient

You may not qualify if:

  • Minor patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

Study Officials

  • Christophe MARIAT, MD PhD

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 19, 2015

Study Start

March 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

FR(1)