Actively Recruiting
A Clinical Study Using FAPI-PET Imaging to Evaluate the Effects of TAVI on Reversing Myocardial Structural and Functional Remodeling in Patients With Aortic Stenosis
Led by RenJi Hospital · Updated on 2026-01-13
25
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
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 heart's 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 PET/CT 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.
CONDITIONS
Brief Title
A Clinical Study Using FAPI-PET Imaging to Assess the Postoperative Effects of TAVI in Patients With Aortic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Confirmed diagnosis of severe degenerative aortic stenosis by echocardiography (valve area < 1.0 cm² or mean transvalvular gradient > 40 mmHg; for low-flow, low-gradient AS with reduced ejection fraction, presence of outflow tract reserve confirmed by dobutamine stress)
- Evaluated by heart team as unsuitable for surgical valve replacement due to advanced age or severe comorbidities
- No anatomical contraindications for transcatheter valve implantation
- Expected to benefit from transcatheter valve implantation
- Patients choosing to undergo TAVI assigned to TAVI group; those not undergoing valve replacement assigned to control group
You will not qualify if you...
- Recent acute myocardial infarction (less than 1 month) or active myocarditis, infectious endocarditis, or other acute inflammatory conditions
- History of old myocardial infarction with myocardial scarring
- Uncontrolled severe arrhythmias such as persistent ventricular tachycardia, ventricular fibrillation, or high-risk second-degree or higher atrioventricular block causing hemodynamic instability within past 3 months
- Severe cardiovascular diseases affecting study evaluation (e.g., severe mitral regurgitation, hypertrophic obstructive cardiomyopathy, primary pulmonary hypertension)
- Contraindications to examinations: allergy to PET tracers or MRI contrast agents, severe renal insufficiency (eGFR <30 ml/min/1.73 m²), severe claustrophobia preventing imaging compliance
- Allergic constitution with history of multiple drug allergies or unknown substances
- Pregnant or breastfeeding women; females of childbearing potential must have negative pregnancy test before enrollment and use effective contraception during study
- Any other condition increasing study risk or interfering with results (e.g., active malignant tumors, advanced disease with expected survival less than 1 year)
- Inability to comply with protocol or follow-up requirements (e.g., poor adherence, expected inability to attend follow-ups)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants will either undergo transcatheter aortic valve implantation according to standard clinical procedures and receive optimal medication treatment, or receive optimal medication treatment alone.
Baseline visit and 1 follow-up visit at 6 months
Trial Site Locations
Total: 1 location
1
Renji Hospital,Shanghai
Shanghai, China, 201203
Actively Recruiting
Research Team
J
Jun Pu, M.D.
P
Peiliang Fang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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