Acute Kidney Injury Genomics and Biomarkers in TAVR Study

N/AActive Not RecruitingNCT02791880

University of Texas Southwestern Medical Center62 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Acute Kidney Injury

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (3)

Parkland Health & Hospital Systems

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

William J. Clements University Hospital

Dallas, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: Day of procedure to post procedure day 5

Secondary Outcomes

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).