Acute Kidney Injury Genomics and Biomarkers in TAVR Study

Recruiting

Phase N/A Results N/A

Trial Description

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 and urine output 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.

Conditions

Interventions

  • Transcatheter Aortic Valve Replacement Procedure
    Intervention Desc: The investigators will collect blood and urine samples from patients with aortic stenosis who are undergoing transcatheter aortic valve replacement.
    ARM 1: Kind: Experimental
    Label: TAVR patients
    Description: The group of interest is the patient population with aortic stenosis who will undergoing transcatheter aortic valve replacement (TAVR)

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Acute Kidney Injury using KDIGO criteria: albumin/creatinine ratio (>/= 300 mg/g) and eGRF (< 60 mL/min/1.73^2). Day of procedure to post procedure day 5 No
Secondary Chronic renal insufficiency (i.e. number of patients that will have received a diagnosis of chronic renal insufficiency) Day of procedure to year 5 No
Secondary Heart failure per NYHA class II, III, IV Day of procedure to year 5 No
Secondary Presence of Arrhythmia (i.e. number of patients who develop an arrhythmia from postoperative day 0 to 5 years). Day of procedure to year 5 No
Secondary Myocardial Infarction (i.e. number of participants who develop a MI during postoperative day 0 to year 5) Day of procedure to year 5 No
Secondary Cerebrovascular accident (i.e. number of participants who develop transient ischemic attack or permanent stroke during postoperative day 0 up to 5 years) Day of procedure to year 5 No
Secondary Vascular complications (i.e. number of participants who develop arterial injury, dissection, limb ischemia during postoperative day 0 up to year 5) Day of procedure to year 5 No
Secondary Need for dialysis (e.g. number of participants who undergo post-procedural dialysis) Day of procedure to year 5 No
Secondary Mortality (i.e. number of participants who are deceased during postoperative day 0 up to year 5) Day of procedure to year 5 No

Biospecimen Retention:Samples With DNA - DNA collected before procedure. Paired urine, serum, and plasma samples collected before valve replacement, six hours after valve replacement, and post-procedure days 1 and 2. Additional samples are collected on post-procedure days 3, 4 and 5 if the patient develops acute kidney injury after the procedure.

Sponsors