Impact of Trans-catheter Aortic Valve Implantation on Renal Function

NCT07626710 | Recruiting

• 1 other identifier: 3940
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Both contrast-induced acute kidney injury (AKI) and pre-existing chronic kidney disease are associated with an increased mortality risk in patients requiring aortic valve replacement. Nonetheless, the direct haemodynamic impact of the aortic barrage (i.e. pre-renal mechanism) on renal function compromising and its reversibility in patients undergoing trans-catheter aortic valve implantation (TAVI) is unknown. This registry aims to evaluate the effect of severe aortic stenosis removal on the risk of contrast-induced acute renal injury (CI-AKI) during TAVI procedures and on renal function evolution

Conditions

Aortic Valve Stenosis; Chronic Kidney Diseases; Renal Failure Acute Chronic

Keywords

Trans-catheter aortic valve implantation; Contrast-induced acute renal injury; Kidney failure; Observational registry

Outcome Measures

Primary Outcomes (2)

• Rate of Contrast-induced acute kidney injuy

  contrast medium induced acute kidney injury according to KDIGO classification

  In-hospital (up to day 5)

• Rate of 1-year mortality

  Incidence of 1-year mortality after TAVI procedure in patients with and without post-procedural CI-AKI.

  1-year follow-up

Secondary Outcomes (3)

• Rate of 30-day procedural safety

  1-month follow-up

• Days of hospitalization

  In hospital (up to day 30)

• Rate of 5-year major cardiovascular event

  5-year follow-up

Other Outcomes (4)

• Clinical predictors of contrast-induced acute kidney injury in TAVI

  In-hospital (up to day 5)

• Impact of AKI in surgical vs percutaneous treatment of aortic stenosis

  30-day follow up

• Post TAVI acute kidney injury risk in patients with concurrent coronary artery disease

  In-hospital (up to day 5)

Study Arms (1)

TAVI patients

All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution during the study period.

Procedure: Trans-catheter aortic valve implantation (TAVI)

Interventions

Trans-catheter aortic valve implantation (TAVI) PROCEDURE

Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis

TAVI 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

All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution will be eligible for the study.

You may qualify if:

• Age \>18 years with a life expectancy \>1 year;
• Patient candidate for percutaneous aortic valve implantation after formal indication of our "Heart Team".
• Patient performed at least one contrast-based exam other than the TAVI procedure in the previous two months.
• Patients had adequate renal function assessment after each contrast medium administration (TAVI procedure included) with at least three post-procedural measurements in the following 5 days.
• Patients were informed of the possibility to be the object of anonymized data collection for study protocols approved by the internal Ethical Committee and had provided written informed consent to the procedure (for patients before 2018) or had provided written informed consent to the research purposes of IRCCS (for patients from 2018 to date).

You may not qualify if:

• Female with childbearing potential or lactating;
• Acute or chronic end-stage renal dysfunction defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2);
• Candidate for dialysis treatment;
• Co-morbidities that could interfere with the completion of study procedures, or life expectancy of less than 1 year;
• Absent or incomplete renal function assessment after each contrast-based procedure;
• Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Enrico Romagnoli

Roma, RM, 00168, Italy

RECRUITING

Related Publications (12)

• Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.

  PMID: 30883053 BACKGROUND

• Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.

  PMID: 30883058 BACKGROUND

• Thongprayoon C, Cheungpasitporn W, Mao MA, Srivali N, Kittanamongkolchai W, Harrison AM, Greason KL, Kashani KB. Persistent acute kidney injury following transcatheter aortic valve replacement. J Card Surg. 2017 Sep;32(9):550-555. doi: 10.1111/jocs.13200. Epub 2017 Aug 22.

  PMID: 28833503 BACKGROUND

• Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.

  PMID: 17331245 BACKGROUND

• Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.

  PMID: 15312219 BACKGROUND

• Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

  PMID: 22890468 BACKGROUND

• Burzotta F, Aurigemma C, Romagnoli E, Shoeib O, Russo G, Zambrano A, Verdirosi D, Leone AM, Bruno P, Trani C. A less-invasive totally-endovascular (LITE) technique for trans-femoral transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2020 Aug;96(2):459-470. doi: 10.1002/ccd.28697. Epub 2020 Jan 11.

  PMID: 31925991 BACKGROUND

• De Silva K, Morton G, Sicard P, Chong E, Indermuehle A, Clapp B, Thomas M, Redwood S, Perera D. Prognostic utility of BCIS myocardial jeopardy score for classification of coronary disease burden and completeness of revascularization. Am J Cardiol. 2013 Jan 15;111(2):172-7. doi: 10.1016/j.amjcard.2012.09.012. Epub 2012 Oct 24.

  PMID: 23102883 BACKGROUND

• Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Am Coll Cardiol. 2012 Oct 9;60(15):1438-54. doi: 10.1016/j.jacc.2012.09.001.

  PMID: 23036636 BACKGROUND

• Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. doi: 10.1111/j.1523-1755.2005.00365.x.

  PMID: 15882252 BACKGROUND

• Faillace BLR, Ribeiro HB, Campos CM, Truffa AAM, Bernardi FL, Oliveira MDP, Mariani J Jr, Marchini JF, Tarasoutchi F, Lemos PA. Potential of transcatheter aortic valve replacement to improve post-procedure renal function. Cardiovasc Revasc Med. 2017 Oct-Nov;18(7):507-511. doi: 10.1016/j.carrev.2017.03.031. Epub 2017 Apr 2.

  PMID: 29054156 BACKGROUND

• Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for Universal Definition of Myocardial Infarction; Authors/Task Force Members Chairpersons; Thygesen K, Alpert JS, White HD; Biomarker Subcommittee; Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA; ECG Subcommittee; Chaitman BR, Clemmensen PM, Johanson P, Hod H; Imaging Subcommittee; Underwood R, Bax JJ, Bonow JJ, Pinto F, Gibbons RJ; Classification Subcommittee; Fox KA, Atar D, Newby LK, Galvani M, Hamm CW; Intervention Subcommittee; Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J; Trials & Registries Subcommittee; Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML; Trials & Registries Subcommittee; Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G; Trials & Registries Subcommittee; Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D; Trials & Registries Subcommittee; Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG); Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S; Document Reviewers; Morais J, Aguiar C, Almahmeed W, Arnar DO, Barili F, Bloch KD, Bolger AF, Botker HE, Bozkurt B, Bugiardini R, Cannon C, de Lemos J, Eberli FR, Escobar E, Hlatky M, James S, Kern KB, Moliterno DJ, Mueller C, Neskovic AN, Pieske BM, Schulman SP, Storey RF, Taubert KA, Vranckx P, Wagner DR. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012 Oct 16;60(16):1581-98. doi: 10.1016/j.jacc.2012.08.001. Epub 2012 Sep 5. No abstract available.

  PMID: 22958960 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Renal Insufficiency, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; 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

Study Officials

• Enrico Romagnoli

  Fondazione Policlinico Universitario Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Romagnoli, MD, PhD

CONTACT

+390630154187; enromagnoli@gmail.com

Benedetta Brancadoro

CONTACT

+390630154187; benedetta.brancadoro@unicatt.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher, Interventional Cardiologist

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: June 4, 2026
• Study Start: August 30, 2024
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2033
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: From May 2025 (primary end-point completion) to May 2029 (study end)
• Access Criteria: request to the principal investigator.

Locations

IT (1)