Acute Kidney InjuryNCT02791880
Acute Kidney Injury Genomics and Biomarkers in TAVR Study
An observational study of Acute Kidney Injury and Renal Insufficiency, Chronic, run by University of Texas Southwestern Medical Center at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Renal Insufficiency, Chronic, Heart Failure
- What is being tested?
- Transcatheter Aortic Valve Replacement
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Oct 2016to 2 Dec 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Parkland Health & Hospital Systems
Dallas, Texas, 75235
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
William J. Clements University Hospital
Dallas, Texas, 75390
About this study
Official title: Genomic and Biomarker Predictors of Acute Kidney Injury and Other Post-Procedural Outcomes Following Transcatheter Aortic Valve Replacement
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.
Read the 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
- Being tested
- Transcatheter Aortic Valve Replacement
- Keywords
- acute kidney injury, transcatheter aortic valve replacement, genomics, biomarker
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic, Heart Failure, Myocardial Infarction, Arrhythmias, Cardiac, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ReplacementProcedure or surgery
The investigators will collect blood and urine samples from patients with aortic stenosis who are undergoing transcatheter aortic valve replacement.
| Study group | Role | What they receive |
|---|---|---|
| TAVR patients | The group of interest is the patient population with aortic stenosis who are undergoing transcatheter aortic valve replacement (TAVR) Receives: Procedure: Transcatheter Aortic Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day of procedure to post procedure day 5
Secondary outcomes (11)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Administered once prior to the procedure and 1 month to 5 years after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start25 Oct 2016
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda A Fox, MD, MPH, University of Texas Southwestern Medical Center
- Investigators
- Amanda A Fox, MD, MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791880
- Sponsor's protocol ID
- STU 112015-015
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2016
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Stortecky S, Brinks H, Wenaweser P, Huber C, Pilgrim T, Windecker S, Carrel T, Kadner A. Transcatheter aortic valve implantation or surgical aortic valve replacement as redo procedure after prior coronary artery bypass grafting. Ann Thorac Surg. 2011 Oct;92(4):1324-30; discussion 1230-1. doi: 10.1016/j.athoracsur.2011.05.106. Epub 2011 Aug 31.
PubMed 21880298Elhmidi Y, Bleiziffer S, Deutsch MA, Krane M, Mazzitelli D, Lange R, Piazza N. Acute kidney injury after transcatheter aortic valve implantation: incidence, predictors and impact on mortality. Arch Cardiovasc Dis. 2014 Feb;107(2):133-9. doi: 10.1016/j.acvd.2014.01.002. Epub 2014 Feb 17.
PubMed 24556191Giordana F, D'Ascenzo F, Nijhoff F, Moretti C, D'Amico M, Biondi Zoccai G, Sinning JM, Nickenig G, Van Mieghem NM, Chieffo A, Dumonteil N, Tchetche D, Barbash IM, Waksman R, D'Onofrio A, Lefevre T, Pilgrim T, Amabile N, Codner P, Kornowski R, Yong ZY, Baan J, Colombo A, Latib A, Salizzoni S, Omede P, Conrotto F, La Torre M, Marra S, Rinaldi M, Gaita F. Meta-analysis of predictors of all-cause mortality after transcatheter aortic valve implantation. Am J Cardiol. 2014 Nov 1;114(9):1447-55. doi: 10.1016/j.amjcard.2014.07.081. Epub 2014 Aug 13.
PubMed 25217456Thongprayoon C, Cheungpasitporn W, Srivali N, Ungprasert P, Kittanamongkolchai W, Greason KL, Kashani KB. Acute kidney injury after transcatheter aortic valve replacement: a systematic review and meta-analysis. Am J Nephrol. 2015;41(4-5):372-82. doi: 10.1159/000431337. Epub 2015 Jun 19.
PubMed 26113391Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
PubMed 20961243Najjar M, Salna M, George I. Acute kidney injury after aortic valve replacement: incidence, risk factors and outcomes. Expert Rev Cardiovasc Ther. 2015 Mar;13(3):301-16. doi: 10.1586/14779072.2015.1002467. Epub 2015 Jan 16.
PubMed 25592763Tomey MI, Gidwani UK, Sharma SK. Cardiac critical care after transcatheter aortic valve replacement. Cardiol Clin. 2013 Nov;31(4):607-18, ix. doi: 10.1016/j.ccl.2013.07.006.
PubMed 24188224Bagur R, Webb JG, Nietlispach F, Dumont E, De Larochelliere R, Doyle D, Masson JB, Gutierrez MJ, Clavel MA, Bertrand OF, Pibarot P, Rodes-Cabau J. Acute kidney injury following transcatheter aortic valve implantation: predictive factors, prognostic value, and comparison with surgical aortic valve replacement. Eur Heart J. 2010 Apr;31(7):865-74. doi: 10.1093/eurheartj/ehp552. Epub 2009 Dec 27.
PubMed 20037180Konigstein M, Ben-Assa E, Banai S, Shacham Y, Ziv-Baran T, Abramowitz Y, Steinvil A, Leshem Rubinow E, Havakuk O, Halkin A, Keren G, Finkelstein A, Arbel Y. Periprocedural bleeding, acute kidney injury, and long-term mortality after transcatheter aortic valve implantation. Can J Cardiol. 2015 Jan;31(1):56-62. doi: 10.1016/j.cjca.2014.11.006. Epub 2014 Nov 11.
PubMed 25547551Goldberg R, Dennen P. Long-term outcomes of acute kidney injury. Adv Chronic Kidney Dis. 2008 Jul;15(3):297-307. doi: 10.1053/j.ackd.2008.04.009.
PubMed 18565480Haase-Fielitz A, Haase M, Bellomo R, Dragun D. Genetic polymorphisms in sepsis- and cardiopulmonary bypass-associated acute kidney injury. Contrib Nephrol. 2007;156:75-91. doi: 10.1159/000102072.
PubMed 17464117Bolstad BM, Irizarry RA, Astrand M, Speed TP. A comparison of normalization methods for high density oligonucleotide array data based on variance and bias. Bioinformatics. 2003 Jan 22;19(2):185-93. doi: 10.1093/bioinformatics/19.2.185.
PubMed 12538238Khawaja MZ, Williams R, Hung J, Arri S, Asrress KN, Bolter K, Wilson K, Young CP, Bapat V, Hancock J, Thomas M, Redwood S. Impact of preprocedural mitral regurgitation upon mortality after transcatheter aortic valve implantation (TAVI) for severe aortic stenosis. Heart. 2014 Nov;100(22):1799-803. doi: 10.1136/heartjnl-2014-305775. Epub 2014 Aug 25.
PubMed 25155800Purcell S, Neale B, Todd-Brown K, Thomas L, Ferreira MA, Bender D, Maller J, Sklar P, de Bakker PI, Daly MJ, Sham PC. PLINK: a tool set for whole-genome association and population-based linkage analyses. Am J Hum Genet. 2007 Sep;81(3):559-75. doi: 10.1086/519795. Epub 2007 Jul 25.
PubMed 17701901Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
PubMed 19897823