NCT02000869

Brief Summary

People with CKD have higher prevalence of cardiovascular disease. The mechanism behind this increased risk is complex but there is strong evidence that changes in arterial stiffness play a central role. Arterial stiffness as measured by aortic pulse wave velocity (aPWV) and augmentation index (AIx), is a surrogate marker of cardiovascular organ damage, and is significantly associated with the future risk of clinical events. In addition, aPWV is an independent and powerful predictor of all-cause and cardiovascular mortality in patients on dialysis. Reduction of aPWV, mainly by use of an angiotensin converting enzyme (ACE)-inhibitor results in an improved survival in dialysis patients. These findings suggest that arterial stiffness is not merely a marker of arterial damage but a potentially reversible factor contributing to mortality in dialysis patients. There is strong evidence that arterial stiffness increases as glomerular filtration rate (GFR) falls. Conversely, arterial stiffness has also been established in a number of studies as a significant risk factor for CKD progression. In addition to arterial stiffness, elevated central aortic blood pressure and central pulse pressure have been shown to increase the risk of progression of CKD to ESRD. Central blood pressure is more strongly related than standard BP measured at the brachial arteries (brachial blood pressure) to concentric left ventricular hypertrophy and carotid artery hypertrophy as well as to future cardiovascular events. Cardiovascular disease remains the foremost cause of death post-kidney transplant. Although, successful kidney transplant has been shown to improve arterial stiffness post-transplant, we do not know to what extent the pre-transplant arterial stiffness and central aortic blood pressure and their improvement post-transplant impact the cardiovascular and allograft outcomes. In addition, it is unclear what transplant related factors are associated with improvement in arterial stiffness and central aortic blood pressure post-transplant. The goals of our study are:

  1. 1.To determine if pre-transplant central blood pressure and aortic stiffness impact post-transplant cardiovascular and kidney allograft outcomes.
  2. 2.To determine whether the changes in central blood pressure and aortic stiffness post-transplant impact cardiovascular and kidney allograft outcomes.
  3. 3.To determine the factors associated with improved central aortic blood pressure and arterial stiffness post-transplant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 14, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

November 27, 2013

Last Update Submit

November 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in central aortic blood pressure and arterial stiffness post-transplant

    2 years

Study Arms (1)

wait-listed kidney transplant candidates

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Wait-listed kidney transplant candidates who have been on the waiting list for at least 2 years

You may qualify if:

  • Wait-listed kidney transplant candidates who have been on the waiting list for at least 2 years

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John C. McDonald Regional Transplant Center

Shreveport, Louisiana, 71103, United States

Location

Study Officials

  • Neeraj Singh, MD

    LSUHSC-Shreveport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 4, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

December 14, 2021

Record last verified: 2021-11

Locations