Health Trials

About this trial

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

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Trans-catheter aortic valve implantation (TAVI)

Treatment groups

1,000 Participants
are divided into 1 treatment group

Locations

1
Enrico Romagnoli00168, RomaRM, Italy

Sponsors and collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Source ClinicalTrials.gov