Study Using FAPI-PET Imaging to Measure Effects of Transcatheter Aortic Valve Implantation on Heart Muscle Changes in Adults with Severe Aortic Stenosis

What this Trial Is About

Researchers are evaluating the effects of transcatheter aortic valve implantation TAVI on patients with severe degenerative aortic stenosis, a condition where the hearts aortic valve narrows and affects blood flow. The study also includes a control group of patients with aortic stenosis who have not undergone valve replacement. The goal is to measure changes in heart tissue and function by comparing those treated with TAVI to patients receiving only medication. Participants will be divided into two groups one group will undergo TAVI following standard clinical procedures along with optimal medication therapy, while the control group will receive only optimal medication treatment. The recommended medications include several categories such as SGLT2 inhibitors, angiotensin receptor-neprilysin inhibitors, beta-blockers, mineralocorticoid receptor antagonists, and individualized diuretics. Each participant will have a special PETCT scan using the FAPI tracer at the start of the study and again six months later to assess heart tissue changes. Throughout the study, enrolled patients will be monitored with FAPI-PET scans to measure myocardial uptake values at baseline and six months after treatment or enrollment. The study will track the activity of heart fibroblasts, structural remodeling of the heart muscle, and changes in cardiac function. Participants are followed for at least six months to evaluate these outcomes, with all clinical and imaging assessments designed to compare the effects of TAVI and medication-only therapy on heart health.

A Clinical Study Using FAPI-PET Imaging to Assess the Postoperative Effects of TAVI in Patients With Aortic Stenosis