Acute Kidney Injury Genomics and Biomarkers in TAVR Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Genomic and Biomarker Predictors of Acute Kidney Injury and Other Post-Procedural Outcomes Following Transcatheter Aortic Valve Replacement

Conditions
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Acute Kidney Injury, Renal Insufficiency, Chronic, Heart Failure, Myocardial Infarction, Arrhythmias, Cardiac, Stroke

Intervention / Treatment
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* Procedure: Transcatheter Aortic Valve Replacement


Participation Criteria
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Eligibility Criteria
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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: The patient cannot or will not provide informed consent. The patient is aged less than 18 years. The patient's pre-procedural hematocrit is less than 25%. The patient has known human immunodeficiency virus infection The patient has known hepatitis C that has not been treated with antiviral medications 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVR patients<br>The group of interest is the patient population with aortic stenosis who are undergoing transcatheter aortic valve replacement (TAVR) | Procedure: Transcatheter Aortic Valve Replacement<br>* The investigators will collect blood and urine samples from patients with aortic stenosis who are undergoing transcatheter aortic valve replacement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury using KDIGO criteria | Data will be collected from electronic medical records; data points to be collected for this measurement include serum creatinine | Day of procedure to post procedure day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic renal insufficiency (i.e. number of patients that will have received a diagnosis of chronic renal insufficiency) | Chronic renal insufficiency is defined as patient having impaired renal function (albumin/creatinine ratio >/= 300 mg/g and eGFR <60 mL/min/1.73^2). | Day of procedure to year 5 | 
| Heart failure per NYHA class II, III, IV | This will be measured in accordance to New York Heart Association Guidelines. | Day of procedure to year 5 | 
| Presence of Arrhythmia (i.e. number of patients who develop an arrhythmia from postoperative day 0 to 5 years). | Data will be collected from electronic medical records; data points to be collected for this measurement include post-procedural EKG reports and progress notes. | Day of procedure to year 5 | 
| Myocardial Infarction (i.e. number of participants who develop a MI during postoperative day 0 to year 5) | Data will be collected from electronic medical records; data points to be collected for this measurement include post-procedural EKG reports, cardiac enzyme values, progress notes, and cardiac catheterization reports. | Day of procedure to year 5 | 
| Cerebrovascular accident (i.e. number of participants who develop transient ischemic attack or permanent stroke during postoperative day 0 up to 5 years) | Data will be collected from electronic medical records; data points to be collected for this measurement include post procedural imaging data and progress notes. | Day of procedure to year 5 | 
| Vascular complications (i.e. number of participants who develop arterial injury, dissection, limb ischemia during postoperative day 0 up to year 5) | Data will be collected from electronic medical records; data points to be collected for this measurement include post procedural imaging data, progress notes and operative reports. | Day of procedure to year 5 | 
| Need for dialysis (e.g. number of participants who undergo post-procedural dialysis) | Data will be collected from electronic medical records; data points to be collected for this measurement include progress notes, and consultation notes. | Day of procedure to year 5 | 
| Mortality (i.e. number of participants who are deceased during postoperative day 0 up to year 5) | Data will be collected from electronic medical records; data points to be collected for this measurement include progress notes and death notes. | Day of procedure to year 5 | 
| KCCQ Quality of Life Survey | The Kansas City Cardiomyopathy Questionnaire (KCCQ Short Form) is a health-related quality of life measure for heart failure. | Administered once prior to the procedure and 1 month to 5 years after hospital discharge | 
| SAQ Quality of Life Survey | The Seattle Angina Questionnaire (SAQ Short Form) is a health-related quality of life measure for coronary artery disease. | Administered once prior to the procedure and 1 month to 5 years after hospital discharge | 
| SF12 Quality of Life Survey | 12-item short form Health survey (SF12) is a health-related quality of life measure of functional health and well-being from the patient's point of view. | Administered once prior to the procedure and 1 month to 5 years after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute kidney injury, transcatheter aortic valve replacement, genomics, biomarker