Acute Kidney Injury Genomics and Biomarkers in TAVR Study

Active, not recruiting

• Conditions: Renal Insufficiency, Chronic; Arrhythmias, Cardiac; Acute Kidney Injury; Stroke; Heart Failure; Myocardial Infarction
• Interventions: Procedure: Transcatheter Aortic Valve Replacement

• Registration Number: NCT02791880
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-07
• Study Start: 2016-10-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18
• Primary Completion: 2031-03-31
• Study Completion: 2031-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAVR patients	Transcatheter Aortic Valve Replacement	The group of interest is the patient population with aortic stenosis who are undergoing transcatheter aortic valve replacement (TAVR)

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury using KDIGO criteria	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 Outcome Measures

Name	Time	Method
Need for dialysis (e.g. number of participants who undergo post-procedural dialysis)	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.
Heart failure per NYHA class II, III, IV	Day of procedure to year 5	This will be measured in accordance to New York Heart Association Guidelines.
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	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.
Mortality (i.e. number of participants who are deceased during postoperative day 0 up to year 5)	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.
SAQ Quality of Life Survey	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.
KCCQ Quality of Life Survey	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.
Chronic renal insufficiency (i.e. number of patients that will have received a diagnosis of chronic renal insufficiency)	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).
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	Data will be collected from electronic medical records; data points to be collected for this measurement include post-procedural EKG reports and progress notes.
Myocardial Infarction (i.e. number of participants who develop a MI during postoperative day 0 to year 5)	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.
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	Data will be collected from electronic medical records; data points to be collected for this measurement include post procedural imaging data and progress notes.
SF12 Quality of Life Survey	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.

Trial Locations

Locations (3)

William J. Clements University Hospital; 🇺🇸 Dallas, Texas, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Parkland Health & Hospital Systems; 🇺🇸 Dallas, Texas, United States