Impact of Trans-catheter Aortic Valve Implantation on Renal Function (TAVIKOD)
31. mai 2026 oppdatert av: Romagnoli Enrico, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Impact of Trans-catheter Aortic Valve Implantation on Kidney Response to Contrast Dye Administration: an Observational Registry
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
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution after the introduction of a standardized approach (2017 - TAVI lite technique) will be eligible for the study. To be enrolled in this registry, patients need to have performed both diagnostic preliminary exams (coronary angiography, percutaneous coronary intervention, or CT) and TAVI procedure in our hospital within maximal time lapse of two months. A complete renal function assessment after each contrast-based procedure (i.e. at least three measurements) is also an essential pre-requisite for enrolment.
Study design: ambispective registry. Estimated population size: 340 for the retrospective phase (based on annual TAVI procedure rate of ~150); 760 for the prospective phase (based on annual TAVI procedure rate of ~200) The incidence of contrast medium-induced acute kidney injury according to Kidney Disease Improving Global Outcomes (KDIGO) classification before and after the TAVI procedure will be the primary end-point of the study. The Incidence of 1-year mortality after TAVI procedure in patients with and without post-procedural CI-AKI will be the co-primary end-point.
Studietype
Observasjonsmessig
Registrering (Antatt)
1000
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Enrico Romagnoli, MD, PhD
- Telefonnummer: +390630154187
- E-post: enromagnoli@gmail.com
Studer Kontakt Backup
- Navn: Benedetta Brancadoro
- Telefonnummer: +390630154187
- E-post: benedetta.brancadoro@unicatt.it
Studiesteder
-
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RM
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Roma, RM, Italia, 00168
- Rekruttering
- Enrico Romagnoli
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Ta kontakt med:
- Enrico Romagnoli, MD, PhD
- Telefonnummer: +393291424342
- E-post: enrico.romagnoli@policlinicogemelli.it
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Ta kontakt med:
- Benedetta Brancadoro
- Telefonnummer: +390630156622
- E-post: benedetta.brancadoro@unicatt.it
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Underetterforsker:
- Francesco Burzotta, MD, PhD
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Underetterforsker:
- Cristina Aurigemma, MD, PhD
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Underetterforsker:
- Carlo Trani, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution will be eligible for the study.
Beskrivelse
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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;
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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TAVI patients
All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution during the study period.
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Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of Contrast-induced acute kidney injuy
Tidsramme: In-hospital (up to day 5)
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contrast medium induced acute kidney injury according to KDIGO classification
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In-hospital (up to day 5)
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Rate of 1-year mortality
Tidsramme: 1-year follow-up
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Incidence of 1-year mortality after TAVI procedure in patients with and without post-procedural CI-AKI.
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1-year follow-up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of 30-day procedural safety
Tidsramme: 1-month follow-up
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Procedure 30-day safety endpoint including: all cause mortality, stroke, infections, sepsis.
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1-month follow-up
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Days of hospitalization
Tidsramme: In hospital (up to day 30)
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Days of hospitalization following TAVI procedure
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In hospital (up to day 30)
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Rate of 5-year major cardiovascular event
Tidsramme: 5-year follow-up
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Five-year composite rate of all-cause mortality, stroke, myocardial infarction, coronary revascularization, hospitalization
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5-year follow-up
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical predictors of contrast-induced acute kidney injury in TAVI
Tidsramme: In-hospital (up to day 5)
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Patient-related and procedure-related elements associated with the risk of post TAVI acute kidney injury
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In-hospital (up to day 5)
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Impact of AKI in surgical vs percutaneous treatment of aortic stenosis
Tidsramme: 30-day follow up
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Comparison between percutaneous and surgical aortic stenosis treatment in patients with contrast medium-induced AKI during preliminary diagnostic exams
|
30-day follow up
|
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Post TAVI acute kidney injury risk in patients with concurrent coronary artery disease
Tidsramme: In-hospital (up to day 5)
|
Incidence of AKI in patients with concurrent coronary artery disease (CAD)
|
In-hospital (up to day 5)
|
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Peri-procedural bleeding incidence in patients with post-procedural CI-AKI
Tidsramme: 30-day follow up
|
Assessment of access-related and non access related bleeding incidence in patients with and without post-procedural CI-AKI.
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30-day follow up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Enrico Romagnoli, Fondazione Policlinico Universitario Agostino Gemelli
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. august 2024
Primær fullføring (Antatt)
30. august 2028
Studiet fullført (Antatt)
30. august 2033
Datoer for studieregistrering
Først innsendt
9. mars 2023
Først innsendt som oppfylte QC-kriteriene
31. mai 2026
Først lagt ut (Faktiske)
4. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Aortaklaffsykdom
- Urogenitale sykdommer
- Kardiovaskulære sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Hjertesykdommer
- Kronisk sykdom
- Sykdomsattributter
- Hjerteklaffsykdommer
- Ventrikulær utstrømningsobstruksjon
- Patologiske tilstander, tegn og symptomer
- Aortaklaffstenose
- Nyreinsuffisiens
- Nyresvikt, kronisk
Andre studie-ID-numre
- 3940
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
All IPD that underlie published results will be shared on reasonable request to the principal investigator.
IPD-delingstidsramme
From May 2025 (primary end-point completion) to May 2029 (study end)
Tilgangskriterier for IPD-deling
request to the principal investigator.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .