Official Title
Genomic and Biomarker Predictors of Acute Kidney Injury and Other Post-Procedural Outcomes Following Transcatheter Aortic Valve Replacement
Brief Title
Acute Kidney Injury Genomics and Biomarkers in TAVR Study
Protocol ID
NCT02791880
Lead Sponsor
University of Texas Southwestern Medical Center
Brief Summary
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.
Detailed Description
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
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.
Study Period
-
Enrollment Count
62 participants
Eligibility Criteria
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 human immunodeficiency virus infection
5. The patient has known hepatitis C that has not been treated with antiviral
medications
6. In the opinion of the principal investigator, the patient will be unlikely to
complete long-term follow up for medical or social reasons (this includes transient
patients and patients who have no fixed address).
Filters
Acute Kidney Injury
Renal Insufficiency, Chronic
Heart Failure
Myocardial Infarction
Arrhythmias, Cardiac
Stroke
ACTIVE_NOT_RECRUITING
ADULT
OLDER_ADULT