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

NCT07335900 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-13

No results posted yet for this study

Summary

This study will include patients with severe degenerative aortic stenosis (AS) who meet the inclusion criteria and voluntarily participate (planned to undergo TAVI), as well as patients with aortic stenosis who have not undergone valve replacement (control group). All enrolled patients will undergo a \^18F-FAPI-1801 PET/CT scan at baseline (before or at the time of TAVI) and 6 months postoperatively to quantitatively evaluate myocardial fibroblast activation and structural remodeling indicators, and to follow up on changes in clinical cardiac function. Patients with aortic stenosis receiving only medical therapy will be set as the control group for comparative analysis, to assess the impact of relieving aortic stenosis on the reduction of myocardial fibrosis activity, myocardial remodeling, and reversal of cardiac function.

Conditions

  • Severe Aortic Valve Stenosis

Interventions

PROCEDURE

Transcatheter Aortic Valve Implantation

Patients in the TAVI group underwent transcatheter aortic valve implantation performed by the hospital's cardiac intervention team according to standard clinical procedures, and received optimal medical therapy（The recommended medications include: First category: SGLT2 inhibitors (gliflozin drugs) such as dapagliflozin and empagliflozin; Second category: Angiotensin receptor-neprilysin inhibitors (ARNI) with the representative drug sacubitril/valsartan; Third category: β-blockers (the '-lol' class) with representative drugs including bisoprolol, metoprolol sustained-release tablets, and carvedilol; Fourth category: Mineralocorticoid receptor antagonists (MRA, aldosterone receptor antagonists) with representative drugs spironolactone and eplerenone; Fifth category (for specific populations): vericiguat. Diuretics should be individualized, including loop diuretics such as furosemide and torasemide.）.

DRUG

Optimal medication treatment

All enrolled patients must receive the Optimal medication treatment（The recommended medications include: First category: SGLT2 inhibitors (gliflozin drugs) such as dapagliflozin and empagliflozin; Second category: Angiotensin receptor-neprilysin inhibitors (ARNI) with the representative drug sacubitril/valsartan; Third category: β-blockers (the '-lol' class) with representative drugs including bisoprolol, metoprolol sustained-release tablets, and carvedilol; Fourth category: Mineralocorticoid receptor antagonists (MRA, aldosterone receptor antagonists) with representative drugs spironolactone and eplerenone; Fifth category (for specific populations): vericiguat. Diuretics should be individualized, including loop diuretics such as furosemide and torasemide.）.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Jun PU · RenJi Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-19
Primary Completion
2026-12-30
Completion
2027-05-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07335900 on ClinicalTrials.gov