Impact of Arterial Stiffness and Central Aortic Blood Pressure on Kidney Transplant Outcomes
Impact of Pre- and Post-transplant Arterial Stiffness and Central Aortic Blood Pressure on Post-kidney Transplant Cardiovascular and Allograft Outcomes
1 other identifier
observational
40
1 country
1
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.To determine if pre-transplant central blood pressure and aortic stiffness impact post-transplant cardiovascular and kidney allograft outcomes.
- 2.To determine whether the changes in central blood pressure and aortic stiffness post-transplant impact cardiovascular and kidney allograft outcomes.
- 3.To determine the factors associated with improved central aortic blood pressure and arterial stiffness post-transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2014
1 active site
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
First Submitted
Initial submission to the registry
November 27, 2013
CompletedFirst Posted
Study publicly available on registry
December 4, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedDecember 14, 2021
November 1, 2021
2 years
November 27, 2013
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
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
Study Officials
- PRINCIPAL INVESTIGATOR
Neeraj Singh, MD
LSUHSC-Shreveport
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