Acute Kidney Injury Genomics and Biomarkers in TAVR Study

StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Trial completed Show 6 more changesShow less
    • Primary completion date changed from estimate of Mar 31, 2031 to Dec 2, 2024
    • Enrollment target: 62 to 61
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 2 of 11 entries
    • Site details revised at 1 of 3 sites
    • Publications: details revised at 16 of 16 entries
  2. Enrollment target: estimated 3000 to confirmed 62v10
  3. Re-verified, no change to tracked fieldsv9
  4. Study Status, Referencesv8
  5. Primary endpoint revised
    • Eligibility criteria expanded, about 22 words
    • Study description shortened, about 4 words
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Re-verified, no change to tracked fieldsv6
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v5
  3. Re-verified, no change to tracked fieldsv4
  4. Primary and study completion dates: Mar 2031 to Mar 31, 2031
    • Secondary endpoints: 8 to 11
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    • Start date: Sep 2016 to Oct 25, 2016
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Texas Southwestern Medical Center
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and 1 more disease
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.
Trial Details
NCT Number NCT02791880
Lead Sponsor University of Texas Southwestern Medical Center
Conditions
(from sponsor)		 Acute Kidney Injury, Renal Insufficiency, Chronic, Heart Failure, Myocardial Infarction, Arrhythmias, Cardiac, Stroke
Related terms Acute Kidney Injury, Arrhythmias, Cardiac, Heart Failure, Myocardial Infarction, Renal Insufficiency, Chronic, Stroke
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov