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NCT Number: NCT02791880

Acute Kidney Injury Genomics and Biomarkers in TAVR Study

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.

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Key information

Conditions

Acute Kidney Injury Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Infarction Ischemia Kidney Diseases Male Urogenital Diseases Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Stroke Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Parkland Health & Hospital Systems, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Transcatheter aortic valve replacement

Procedure

The investigators will collect blood and urine samples from patients with aortic stenosis who are undergoing transcatheter aortic valve replacement.

Primary outcomes

  1. Acute Kidney Injury using KDIGO criteria

    Time frame: Day of procedure to post procedure day 5

    Data will be collected from electronic medical records; data points to be collected for this measurement include serum creatinine

Secondary outcomes

  1. Chronic renal insufficiency (i.e. number of patients that will have received a diagnosis of chronic renal insufficiency)

    Time frame: Day of procedure to year 5

    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).

  2. Heart failure per NYHA class II, III, IV

    Time frame: Day of procedure to year 5

    This will be measured in accordance to New York Heart Association Guidelines.

  3. Presence of Arrhythmia (i.e. number of patients who develop an arrhythmia from postoperative day 0 to 5 years).

    Time frame: Day of procedure to year 5

    Data will be collected from electronic medical records; data points to be collected for this measurement include post-procedural EKG reports and progress notes.

  4. Myocardial Infarction (i.e. number of participants who develop a MI during postoperative day 0 to year 5)

    Time frame: Day of procedure 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.

  5. Cerebrovascular accident (i.e. number of participants who develop transient ischemic attack or permanent stroke during postoperative day 0 up to 5 years)

    Time frame: Day of procedure to year 5

    Data will be collected from electronic medical records; data points to be collected for this measurement include post procedural imaging data and progress notes.

  6. Vascular complications (i.e. number of participants who develop arterial injury, dissection, limb ischemia during postoperative day 0 up to year 5)

    Time frame: Day of procedure 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.

  7. Need for dialysis (e.g. number of participants who undergo post-procedural dialysis)

    Time frame: Day of procedure to year 5

    Data will be collected from electronic medical records; data points to be collected for this measurement include progress notes, and consultation notes.

  8. Mortality (i.e. number of participants who are deceased during postoperative day 0 up to year 5)

    Time frame: Day of procedure 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.

  9. KCCQ Quality of Life Survey

    Time frame: Administered once prior to the procedure and 1 month to 5 years after hospital discharge

    The Kansas City Cardiomyopathy Questionnaire (KCCQ Short Form) is a health-related quality of life measure for heart failure.

  10. SAQ Quality of Life Survey

    Time frame: Administered once prior to the procedure and 1 month to 5 years after hospital discharge

    The Seattle Angina Questionnaire (SAQ Short Form) is a health-related quality of life measure for coronary artery disease.

  11. SF12 Quality of Life Survey

    Time frame: Administered once prior to the procedure and 1 month to 5 years after hospital discharge

    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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2031
Study completion
2031
First posted
Jun 7, 2016
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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