Acute Kidney Injury Genomics and Biomarkers in TAVR Study

NCT ID: NCT02791880

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-25
• Study Completion Date: 2031-03-31

Brief Summary

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 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

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TAVR patients

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

Transcatheter Aortic Valve Replacement

Intervention Type: PROCEDURE

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

Interventions

Transcatheter Aortic Valve Replacement

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

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Amanda A Fox, MD, MPH

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amanda A Fox, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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

Countries

United States

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Other Identifiers

STU 112015-015

Identifier Type: -

Identifier Source: org_study_id