Acute Kidney Injury Genomics and Biomarkers in TAVR Study
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Cardiology, Cardiology, Cardiology, Hospital, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology, Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/6/2018 |
| Start Date: | October 25, 2016 |
| End Date: | March 31, 2031 |
| Contact: | Amanda A Fox, MD, MPH |
| Email: | Amanda.Fox@UTSouthwestern.edu |
| Phone: | 214-648-5849 |
Genomic and Biomarker Predictors of Acute Kidney Injury and Other Post-Procedural Outcomes Following Transcatheter Aortic Valve Replacement
In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly
utilized alternative procedure for replacing a stenotic aortic valve. This study collects
clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in
order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR
and to identify key clinical and procedural predictors of AKI. This study seeks to identify
blood and urine biomarkers that can be used for early detection of AKI around the time of the
procedure. The study seeks to assess for novel genetic variants associated with development
of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and
biomarkers that are associated with adverse cardiovascular events after TAVR and to further
explore how these events may inter-relate with acute kidney injury.
utilized alternative procedure for replacing a stenotic aortic valve. This study collects
clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in
order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR
and to identify key clinical and procedural predictors of AKI. This study seeks to identify
blood and urine biomarkers that can be used for early detection of AKI around the time of the
procedure. The study seeks to assess for novel genetic variants associated with development
of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and
biomarkers that are associated with adverse cardiovascular events after TAVR and to further
explore how these events may inter-relate with acute kidney injury.
This study enrolls patients who have aortic stenosis who undergo TAVR at the University of
Texas Southwestern Medical Center University Hospital. Development of post-TAVR AKI defined
according to the Kidney Disease: Improving Global Outcomes (KDIGO) SCr based and urine output
based criteria will be ascertained. Patients will be followed during primary hospitalization
and during the 5 years following TAVR for adverse kidney outcomes as well as potentially
related adverse cardiovascular outcomes. Clinical and procedural data is collected for each
study patient. All subjects will have paired blood and urine collection done pre-TAVR, 6
hours after aortic valve prosthesis deployment, and on post-procedure days 1 and 2. Subjects
who develop AKI will also have paired blood and urine samples collected on days 3, 4 and 5.
Patients receive follow-up questionnaires by mail or email asking about hospitalizations as
well as visits to cardiology, nephrology and primary care physicians. Questionnaires will
also ask about health-related quality of life using validated study questionnaires. Patient
follow-up will occur at regular intervals until 5 years after TAVR procedure.
Texas Southwestern Medical Center University Hospital. Development of post-TAVR AKI defined
according to the Kidney Disease: Improving Global Outcomes (KDIGO) SCr based and urine output
based criteria will be ascertained. Patients will be followed during primary hospitalization
and during the 5 years following TAVR for adverse kidney outcomes as well as potentially
related adverse cardiovascular outcomes. Clinical and procedural data is collected for each
study patient. All subjects will have paired blood and urine collection done pre-TAVR, 6
hours after aortic valve prosthesis deployment, and on post-procedure days 1 and 2. Subjects
who develop AKI will also have paired blood and urine samples collected on days 3, 4 and 5.
Patients receive follow-up questionnaires by mail or email asking about hospitalizations as
well as visits to cardiology, nephrology and primary care physicians. Questionnaires will
also ask about health-related quality of life using validated study questionnaires. Patient
follow-up will occur at regular intervals until 5 years after TAVR procedure.
Inclusion criteria: Subjects are eligible to participate if they are undergoing TAVR for
aortic stenosis at the University of Texas Southwestern Medical Center.
Exclusion Criteria:
1. The patient cannot or will not provide informed consent.
2. The patient is aged less than 18 years.
3. The patient's pre-procedural hematocrit is less than 25%.
4. The patient has known hepatitis C and/or human immunodeficiency virus infection
5. In the opinion of the principal investigator, the patient will be unlikely to complete
long-term follow up for medical or social reasons.
We found this trial at
3
sites
1801 Inwood Rd
Dallas, Texas 75390
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-5849
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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