Clinical trial NCT02791880: Acute Kidney Injury Genomics and Biomarkers in TAVR Study
Official title: Genomic and Biomarker Predictors of Acute Kidney Injury and Other Post-Procedural Outcomes Following Transcatheter Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Kidney Injury
Renal Insufficiency, Chronic
Heart Failure
Myocardial Infarction
Arrhythmias, Cardiac
Stroke
Keywords: acute kidney injury
transcatheter aortic valve replacement
genomics
biomarker
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be enrolled from the population of patients with aortic stenosis undergoing TAVR. Enrollment will likely occur over a 15 year time period to reach target enrollment. A total of 3,000 subjects are presently targeted for enrollment at University of Texas Southwestern University Hospitals and Parkland Health and Hospital Systems.

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.

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).

Primary outcomes:
measure: Acute Kidney Injury using KDIGO criteria
timeFrame: Day of procedure to post procedure day 5
Secondary outcomes:
measure: Chronic renal insufficiency (i.e. number of patients that will have received a diagnosis of chronic renal insufficiency)
timeFrame: Day of procedure to year 5
measure: Heart failure per NYHA class II, III, IV
timeFrame: Day of procedure to year 5
measure: Presence of Arrhythmia (i.e. number of patients who develop an arrhythmia from postoperative day 0 to 5 years).
timeFrame: Day of procedure to year 5
measure: Myocardial Infarction (i.e. number of participants who develop a MI during postoperative day 0 to year 5)
timeFrame: Day of procedure to year 5
measure: Cerebrovascular accident (i.e. number of participants who develop transient ischemic attack or permanent stroke during postoperative day 0 up to 5 years)
timeFrame: Day of procedure to year 5
measure: Vascular complications (i.e. number of participants who develop arterial injury, dissection, limb ischemia during postoperative day 0 up to year 5)
timeFrame: Day of procedure to year 5
measure: Need for dialysis (e.g. number of participants who undergo post-procedural dialysis)
timeFrame: Day of procedure to year 5
measure: Mortality (i.e. number of participants who are deceased during postoperative day 0 up to year 5)
timeFrame: Day of procedure to year 5
measure: KCCQ Quality of Life Survey
timeFrame: Administered once prior to the procedure and 1 month to 5 years after hospital discharge
measure: SAQ Quality of Life Survey
timeFrame: Administered once prior to the procedure and 1 month to 5 years after hospital discharge
measure: SF12 Quality of Life Survey
timeFrame: Administered once prior to the procedure and 1 month to 5 years after hospital discharge
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health & Hospital Systems
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Dallas
country: United States
facility: William J. Clements University Hospital
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Amanda A Fox, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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