An observational study in Acute Kidney Injury, Renal Insufficiency, Chronic and Heart Failure, sponsored by University of Texas Southwestern Medical Center. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by University of Texas Southwestern Medical Center · Observational
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 62 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 101 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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 group of interest is the patient population with aortic stenosis who are undergoing transcatheter aortic valve replacement (TAVR)
Procedure: Transcatheter Aortic Valve Replacement
The investigators will collect blood and urine samples from patients with aortic stenosis who are undergoing transcatheter aortic valve replacement.
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
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Administered once prior to the procedure and 1 month to 5 years after hospital discharge
Plan to share: Yes — There is a possibility that individual participant data and samples will be de-identified and shared with other cohort study investigators for purposes of replicating biomarker and genetic associations with adverse outcomes.
Supporting information: Sap, Csr
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Texas Southwestern Medical Center