Acute Kidney Injury Genomics and Biomarkers in TAVR Study

NCT02791880 | Active Not Recruiting

• 1 other identifier: STU 112015-015
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

acute kidney injury; transcatheter aortic valve replacement; genomics; biomarker

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  Day of procedure to year 5

• Heart failure per NYHA class II, III, IV

  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).

  Day of procedure to year 5

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

  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)

  Day of procedure to year 5

Study Arms (1)

TAVR patients

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

Procedure: Transcatheter Aortic Valve Replacement

Interventions

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.

TAVR patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (3)

Parkland Health & Hospital Systems

Dallas, Texas, 75235, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

William J. Clements University Hospital

Dallas, Texas, 75390, United States

Location

Related Publications (16)

• 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.

  PMID: 21880298 BACKGROUND

• Elhmidi 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.

  PMID: 24556191 BACKGROUND

• Giordana 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.

  PMID: 25217456 BACKGROUND

• Thongprayoon 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.

  PMID: 26113391 BACKGROUND

• Leon 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.

  PMID: 20961243 BACKGROUND

• Najjar 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.

  PMID: 25592763 BACKGROUND

• Tomey 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.

  PMID: 24188224 BACKGROUND

• Bagur 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.

  PMID: 20037180 BACKGROUND

• Konigstein 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.

  PMID: 25547551 BACKGROUND

• Goldberg 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.

  PMID: 18565480 BACKGROUND

• Haase-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.

  PMID: 17464117 BACKGROUND

• Bolstad 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.

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• Khawaja 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.

  PMID: 25155800 BACKGROUND

• Purcell 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.

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  PMID: 28181420 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA collected before procedure. Paired urine, serum, and plasma samples collected before valve replacement, six hours after valve replacement, and post-procedure days 1 and 2. Additional samples are collected on post-procedure days 3, 4 and 5 if the patient develops acute kidney injury after the procedure.

MeSH Terms

Conditions

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

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Amanda A Fox, MD, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: June 7, 2016
• Study Start: October 25, 2016
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Data will become available at the discretion of the sponsor/Dr. Fox. Once enough data has been gathered and analyzed, and the need or DUA requests from other cohort researchers is received.
• Access Criteria: Data will be collected in REDCap, a data management tool used primarily for research and QI. It is a secure, HIPAA-compliant web application. Content is backed up offsite nightly and hosted in a secure environment maintained by UTSW Information Resources. Other cohort researchers will access survey questionnaires via the secure and confidential REDCap webpage with specific view only access. Patient confidentiality is of paramount importance. Data sent outside of UTSW will be de-identified or coded. The "key" to the code (i.e. patient identifying information) will not be provided to the recipient unless a limited dataset is approved for sharing via a data use agreement between Dr. Fox/UTSW and the recipient scientist/recipient scientist's institution.

Locations

US (3)