Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-02 @ 3:25 AM
Study NCT ID:
NCT07294495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Henagliflozin on Myocardial Fibrosis in Non-Obstructive HCM: A Randomized, Double-Blind, Placebo-Controlled Trial Using 68Ga/18F-FAPI PET/CMR
Sponsor:
Shanghai East Hospital
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effect of Henagliflozin on Myocardial Fibrosis Burden in Patients With Non-Obstructive Hypertrophic Cardiomyopathy Using 68Ga/18F-FAPI PET/CMR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
his is a single-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of Henagliflozin (an SGLT2 inhibitor) on myocardial fibrosis burden in patients with non-obstructive hypertrophic cardiomyopathy (nHCM). The study will use 68 68 Ga/ 18 18 F-FAPI PET/CMR imaging to quantitatively assess changes in active fibroblast activity after 6 months of treatment. A total of 150 eligible adult patients with nHCM (FAPI-positive at baseline, NYHA class I-III) will be enrolled and randomized in a 1:1 ratio to either the Henagliflozin group (10 mg once daily) or the placebo group for a 6-month treatment period. The primary endpoint is the change in myocardial FAPI target-to-background ratio (ΔTBR) at 6 months. Secondary endpoints include changes in FAPI SUVmax, FAPI burden percentage (FAV%), cardiac structure and function parameters, 6-minute walk distance, NYHA classification, NT-proBNP levels, and quality-of-life scores. Exploratory analyses will assess clinical events over 12 months, such as heart failure hospitalization, atrial fibrillation, ventricular arrhythmias, and cardiovascular death. The study employs stratified block randomization based on baseline FAPI burden, central randomization and blinding via IWRS, independent core laboratory imaging evaluation, and an intention-to-treat analytical approach. It aims to provide early evidence for the anti-fibrotic effect of Henagliflozin in nHCM and to validate FAPI-PET/CMR as an imaging biomarker for fibrosis activity.
Detailed Description:
This is a single-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of Henagliflozin, an SGLT2 inhibitor, on myocardial fibrosis burden in patients with non-obstructive hypertrophic cardiomyopathy. The study will utilize integrated Gallium-68 or Fluorine-18 labeled FAPI PET/CMR imaging to quantitatively assess changes in active fibroblast activity following six months of treatment. A total of 150 eligible adult patients with non-obstructive hypertrophic cardiomyopathy, who are FAPI-positive at baseline and classified as NYHA functional class I to III, will be enrolled. Participants will be randomized in a one-to-one ratio to receive either Henagliflozin 10 mg once daily or a matching placebo for a treatment period of six months.
The primary endpoint of the study is the change in myocardial FAPI target-to-background ratio from baseline to six months. Secondary endpoints include changes in other FAPI parameters such as SUVmax and FAPI-active volume percentage, as well as changes in cardiac structure and function parameters assessed by CMR, six-minute walk distance, NYHA functional class, NT-proBNP levels, and quality of life scores. Furthermore, exploratory analyses will assess clinical events over a 12-month period, including heart failure hospitalization, atrial fibrillation, ventricular arrhythmias, and cardiovascular death.
The trial employs a stratified block randomization method based on baseline FAPI burden, with central randomization and blinding maintained through an interactive web response system. All imaging data will be evaluated by an independent core laboratory to ensure objectivity, and statistical analyses will adhere to the intention-to-treat principle. This study aims to generate early evidence regarding the potential anti-fibrotic effect of Henagliflozin in non-obstructive hypertrophic cardiomyopathy and to validate FAPI-PET/CMR as a promising imaging biomarker for monitoring myocardial fibrosis activity.
The primary endpoint of the study is the change in myocardial FAPI target-to-background ratio from baseline to six months. Secondary endpoints include changes in other FAPI parameters such as SUVmax and FAPI-active volume percentage, as well as changes in cardiac structure and function parameters assessed by CMR, six-minute walk distance, NYHA functional class, NT-proBNP levels, and quality of life scores. Furthermore, exploratory analyses will assess clinical events over a 12-month period, including heart failure hospitalization, atrial fibrillation, ventricular arrhythmias, and cardiovascular death.
The trial employs a stratified block randomization method based on baseline FAPI burden, with central randomization and blinding maintained through an interactive web response system. All imaging data will be evaluated by an independent core laboratory to ensure objectivity, and statistical analyses will adhere to the intention-to-treat principle. This study aims to generate early evidence regarding the potential anti-fibrotic effect of Henagliflozin in non-obstructive hypertrophic cardiomyopathy and to validate FAPI-PET/CMR as a promising imaging biomarker for monitoring myocardial fibrosis activity.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: