Impact of Trans-catheter Aortic Valve Implantation on Renal Function (TAVIKOD)
31 maggio 2026 aggiornato da: 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
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Stimato)
1000
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Enrico Romagnoli, MD, PhD
- Numero di telefono: +390630154187
- Email: enromagnoli@gmail.com
Backup dei contatti dello studio
- Nome: Benedetta Brancadoro
- Numero di telefono: +390630154187
- Email: benedetta.brancadoro@unicatt.it
Luoghi di studio
-
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RM
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Roma, RM, Italia, 00168
- Reclutamento
- Enrico Romagnoli
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Contatto:
- Enrico Romagnoli, MD, PhD
- Numero di telefono: +393291424342
- Email: enrico.romagnoli@policlinicogemelli.it
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Contatto:
- Benedetta Brancadoro
- Numero di telefono: +390630156622
- Email: benedetta.brancadoro@unicatt.it
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Sub-investigatore:
- Francesco Burzotta, MD, PhD
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Sub-investigatore:
- Cristina Aurigemma, MD, PhD
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Sub-investigatore:
- Carlo Trani, MD
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution will be eligible for the study.
Descrizione
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;
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Rate of Contrast-induced acute kidney injuy
Lasso di tempo: 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
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Rate of 30-day procedural safety
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Clinical predictors of contrast-induced acute kidney injury in TAVI
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: In-hospital (up to day 5)
|
Incidence of AKI in patients with concurrent coronary artery disease (CAD)
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In-hospital (up to day 5)
|
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Peri-procedural bleeding incidence in patients with post-procedural CI-AKI
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Enrico Romagnoli, Fondazione Policlinico Universitario Agostino Gemelli
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
30 agosto 2024
Completamento primario (Stimato)
30 agosto 2028
Completamento dello studio (Stimato)
30 agosto 2033
Date di iscrizione allo studio
Primo inviato
9 marzo 2023
Primo inviato che soddisfa i criteri di controllo qualità
31 maggio 2026
Primo Inserito (Effettivo)
4 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattia della valvola aortica
- Malattie urogenitali
- Malattia cardiovascolare
- Processi patologici
- Malattie urogenitali maschili
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie cardiache
- Malattia cronica
- Attributi della malattia
- Malattie delle valvole cardiache
- Ostruzione del deflusso ventricolare
- Condizioni patologiche, segni e sintomi
- Stenosi della valvola aortica
- Insufficienza renale
- Insufficienza renale cronica
Altri numeri di identificazione dello studio
- 3940
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
All IPD that underlie published results will be shared on reasonable request to the principal investigator.
Periodo di condivisione IPD
From May 2025 (primary end-point completion) to May 2029 (study end)
Criteri di accesso alla condivisione IPD
request to the principal investigator.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .