Acute Kidney Injury Genomics and Biomarkers in TAVR Study

The University of Texas System (UT)

Status: Active, not recruiting

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

Treatments: Procedure: Transcatheter Aortic Valve Replacement

Study type: Observational

Funder types: Other

Identifiers

NCT02791880

STU 112015-015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

62 participants in 1 patient group

TAVR patients

Description:

The group of interest is the patient population with aortic stenosis who are undergoing transcatheter aortic valve replacement (TAVR)

Treatment:

Procedure: Transcatheter Aortic Valve Replacement