NCT07626710 Impact of Trans-catheter Aortic Valve Implantation on Renal Function
| NCT ID | NCT07626710 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Aortic Valve Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-08-30 |
| Primary Completion | 2028-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-08-30 with a primary completion date of 2028-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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;
Contact & Investigator
Enrico Romagnoli
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli
Frequently Asked Questions
Who can join the NCT07626710 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07626710 currently recruiting?
Yes, NCT07626710 is actively recruiting participants. Contact the research team at enromagnoli@gmail.com for enrollment information.
Where is the NCT07626710 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07626710 clinical trial?
NCT07626710 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Enrico Romagnoli at Fondazione Policlinico Universitario Agostino Gemelli. The trial plans to enroll 1,000 participants.