Impact of Trans-catheter Aortic Valve Implantation on Renal Function (TAVIKOD)
31 mai 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
1000
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Enrico Romagnoli, MD, PhD
- Numéro de téléphone: +390630154187
- E-mail: enromagnoli@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Benedetta Brancadoro
- Numéro de téléphone: +390630154187
- E-mail: benedetta.brancadoro@unicatt.it
Lieux d'étude
-
-
RM
-
Roma, RM, Italie, 00168
- Recrutement
- Enrico Romagnoli
-
Contact:
- Enrico Romagnoli, MD, PhD
- Numéro de téléphone: +393291424342
- E-mail: enrico.romagnoli@policlinicogemelli.it
-
Contact:
- Benedetta Brancadoro
- Numéro de téléphone: +390630156622
- E-mail: benedetta.brancadoro@unicatt.it
-
Sous-enquêteur:
- Francesco Burzotta, MD, PhD
-
Sous-enquêteur:
- Cristina Aurigemma, MD, PhD
-
Sous-enquêteur:
- Carlo Trani, MD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution will be eligible for the study.
La description
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;
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
TAVI patients
All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution during the study period.
|
Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of Contrast-induced acute kidney injuy
Délai: In-hospital (up to day 5)
|
contrast medium induced acute kidney injury according to KDIGO classification
|
In-hospital (up to day 5)
|
|
Rate of 1-year mortality
Délai: 1-year follow-up
|
Incidence of 1-year mortality after TAVI procedure in patients with and without post-procedural CI-AKI.
|
1-year follow-up
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of 30-day procedural safety
Délai: 1-month follow-up
|
Procedure 30-day safety endpoint including: all cause mortality, stroke, infections, sepsis.
|
1-month follow-up
|
|
Days of hospitalization
Délai: In hospital (up to day 30)
|
Days of hospitalization following TAVI procedure
|
In hospital (up to day 30)
|
|
Rate of 5-year major cardiovascular event
Délai: 5-year follow-up
|
Five-year composite rate of all-cause mortality, stroke, myocardial infarction, coronary revascularization, hospitalization
|
5-year follow-up
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical predictors of contrast-induced acute kidney injury in TAVI
Délai: In-hospital (up to day 5)
|
Patient-related and procedure-related elements associated with the risk of post TAVI acute kidney injury
|
In-hospital (up to day 5)
|
|
Impact of AKI in surgical vs percutaneous treatment of aortic stenosis
Délai: 30-day follow up
|
Comparison between percutaneous and surgical aortic stenosis treatment in patients with contrast medium-induced AKI during preliminary diagnostic exams
|
30-day follow up
|
|
Post TAVI acute kidney injury risk in patients with concurrent coronary artery disease
Délai: In-hospital (up to day 5)
|
Incidence of AKI in patients with concurrent coronary artery disease (CAD)
|
In-hospital (up to day 5)
|
|
Peri-procedural bleeding incidence in patients with post-procedural CI-AKI
Délai: 30-day follow up
|
Assessment of access-related and non access related bleeding incidence in patients with and without post-procedural CI-AKI.
|
30-day follow up
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Enrico Romagnoli, Fondazione Policlinico Universitario Agostino Gemelli
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
30 août 2024
Achèvement primaire (Estimé)
30 août 2028
Achèvement de l'étude (Estimé)
30 août 2033
Dates d'inscription aux études
Première soumission
9 mars 2023
Première soumission répondant aux critères de contrôle qualité
31 mai 2026
Première publication (Réel)
4 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladie de la valve aortique
- Maladies urogénitales
- Maladies cardiovasculaires
- Processus pathologiques
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies cardiaques
- Maladie chronique
- Attributs de la maladie
- Maladies des valves cardiaques
- Obstruction de la sortie ventriculaire
- Conditions pathologiques, signes et symptômes
- Sténose valvulaire aortique
- Insuffisance rénale
- Insuffisance rénale chronique
Autres numéros d'identification d'étude
- 3940
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
All IPD that underlie published results will be shared on reasonable request to the principal investigator.
Délai de partage IPD
From May 2025 (primary end-point completion) to May 2029 (study end)
Critères d'accès au partage IPD
request to the principal investigator.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .