HCM - Hypertrophic CardiomyopathyNCT07294495
Effect of Henagliflozin on Myocardial Fibrosis in Non-Obstructive HCM: A Randomized, Double-Blind, Placebo-Controlled Trial Using 68Ga/18F-FAPI PET/CMR
A study testing Henagliflozin (SGLT2 Inhibitor) in people with HCM - Hypertrophic Cardiomyopathy, run by Shanghai East Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCM - Hypertrophic Cardiomyopathy
- What is being tested?
- Henagliflozin (SGLT2 Inhibitor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older, regardless of gender.
- Meets the diagnostic criteria for non-obstructive hypertrophic cardiomyopathy (HCM):
- Confirmed diagnosis of HCM by cardiac magnetic resonance (CMR) or echocardiography (left ventricular wall thickness ≥15 mm, or ≥13 mm in the presence of a family history of HCM).
- Exclusion of patients in whom left ventricular hypertrophy is primarily attributable to hypertensive heart disease, as assessed by a cardiology specialist based on clinical and imaging evidence.
- Exclusion of other identifiable causes of secondary myocardial hypertrophy (e.g., valvular heart disease, storage cardiomyopathies).
- Left ventricular outflow tract (LVOT) gradient <30 mmHg at rest or under provocation, as assessed by echocardiography or CMR.
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- Willing to undergo FAPI PET/CMR examination and complete imaging evaluations.
- Baseline FAPI PET/CMR scan shows positive FAPI uptake: myocardial FAPI target-to-background ratio (TBR) ≥1.3, using the ascending aorta blood pool as the background reference.
- Capable of understanding and signing the informed consent form, and agrees to participate in the study, accept randomization, and comply with follow-up visits.
- New York Heart Association (NYHA) functional class I-III.
Who cannot join
- Significant left ventricular outflow tract obstruction (resting or provoked LVOT pressure gradient ≥30 mmHg).
- Coexistence of other identifiable causes of myocardial hypertrophy, including:
- Predominant or persistent hypertensive heart disease;
- Severe aortic stenosis or other significant valvular heart disease;
- Infiltrative or storage cardiomyopathies (e.g., Fabry disease, amyloidosis);
- Ischemic heart disease (e.g., severe coronary artery disease).
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- Overt decompensated heart failure or NYHA functional class IV.
- Unstable, serious arrhythmias (e.g., sustained ventricular tachycardia, recent cardioversion for atrial fibrillation).
- Recent (within 3 months) cardiac surgery or interventional procedure.
- ALT or AST >3 times the upper limit of normal (ULN), OR total bilirubin (Tbil) >2 times ULN, OR ketonuria/ketonemia, OR eGFR <30 mL/min/1.73m², OR creatine kinase (CK) >3 times ULN.
- Concurrent other severe systemic disease with a life expectancy of less than 1 year.
- Pregnant or breastfeeding women.
- History of allergy to the study drug or any contraindication to its use.
- Any other condition deemed by the investigator to make the subject unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- HCM - Hypertrophic Cardiomyopathy
- Being tested
- Henagliflozin (SGLT2 Inhibitor), Placebo
- Keywords
- PET/MR, FAPI, Hypertrophic Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Henagliflozin (SGLT2 Inhibitor)Drug
This intervention involves the oral administration of Henagliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, at a dose of 10 mg once daily for a period of 6 months. Henagliflozin is provided as a film-coated tablet identical in appearance to the matched placebo used in the control arm. The intervention is administered in a double-blind manner as an add-on to stable standard background therapy for non-obstructive hypertrophic cardiomyopathy. This study specifically investigates the potential anti-fibrotic effects of Henagliflozin on active myocardial fibrosis, as quantified by novel FAPI PET/CMR imaging, in a patient population without diabetes mellitus.
PlaceboDrug
This intervention involves the oral administration of a matched placebo tablet once daily for a period of 6 months. The placebo is manufactured to be identical in appearance (size, shape, color, coating), packaging, and administration schedule to the active comparator, Henagliflozin 10 mg tablet. It contains no active pharmaceutical ingredient. The intervention is administered in a double-blind manner as an add-on to stable standard background therapy for non-obstructive hypertrophic cardiomyopathy, serving as the control to isolate and evaluate the specific pharmacological effects of the SGLT2 inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Henagliflozin (SGLT2 Inhibitor) | Experimental | Participants randomized to this arm will receive a once-daily oral dose of Henagliflozin (10 mg tablet) for a total intervention period of 6 months. Henagliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor. All participants will continue their stable standard background therapy for hypertrophic cardiomyopathy throughout the study. Receives: Drug: Henagliflozin (SGLT2 Inhibitor) |
| Placebo | Placebo comparator | Participants randomized to this arm will receive a once-daily oral dose of a matching placebo tablet for a total intervention period of 6 months. The placebo is identical in appearance, packaging, and administration schedule to the active drug. All participants will continue their stable standard background therapy for hypertrophic cardiomyopathy throughout the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Myocardial FAPI Target-to-Background Ratio (ΔTBR)
The primary outcome is the change in myocardial FAPI uptake quantified by the target-to-background ratio (TBR) on FAPI PET/CMR imaging. TBR is calculated as the ratio of the mean standardized uptake value (SUVmean) in the myocardium to that in the ascending aortic blood pool. The difference in TBR from baseline to 6 months post-intervention (ΔTBR) will be compared between the Henagliflozin and placebo groups. This measure directly reflects changes in active fibroblast activity and myocardial fibrosis burden.
Measured: From baseline to 6 months post-intervention
Secondary outcomes (10)
Change in Myocardial FAPI Maximum Standardized Uptake Value (ΔSUVmax)
This outcome measures the change in the maximum standardized uptake value of FAPI within the myocardium, reflecting the activity of the most intense focal fibrotic lesion. It is quantified from the same FAPI PET/CMR images used for the primary outcome.
Measured: From baseline to 6 months post-intervention
Change in FAPI Activity Volume Percentage (ΔFAV%)
This outcome measures the percentage change in myocardial volume exhibiting active fibrosis. It is calculated by applying a standardized SUV threshold (e.g., SUV ≥ 1.3) to the FAPI PET images to define FAPI-positive voxels and expressing their volume as a percentage of the total left ventricular myocardium volume.
Measured: From baseline to 6 months post-intervention
Change in Left Ventricular Ejection Fraction (ΔLVEF)
This outcome assesses the change in global left ventricular systolic function, measured as the percentage of blood ejected from the left ventricle with each contraction, using cardiac magnetic resonance imaging.
Measured: From baseline to 6 months post-intervention
Change in Left Ventricular Mass Index (ΔLVMi)
This outcome measures the change in left ventricular myocardial mass, adjusted for body surface area, as an indicator of regression or progression of myocardial hypertrophy, assessed via cardiac magnetic resonance.
Measured: From baseline to 6 months post-intervention
Change in Late Gadolinium Enhancement Extent (ΔLGE)
This outcome quantifies the change in the volume or mass of replacement (scar) fibrosis within the left ventricle using the late gadolinium enhancement technique on cardiac magnetic resonance.
Measured: From baseline to 6 months post-intervention
Change in Global Longitudinal Strain (ΔGLS)
This outcome measures the change in myocardial deformation during contraction, specifically the peak systolic longitudinal strain averaged across all left ventricular segments, assessed by CMR feature-tracking. It is a sensitive marker of early myocardial dysfunction.
Measured: From baseline to 6 months post-intervention
Change in 6-Minute Walk Distance (Δ6MWD)
This outcome measures the change in functional exercise capacity by recording the total distance (in meters) a participant can walk on a flat, hard surface in 6 minutes, following standardized guidelines.
Measured: From baseline to 6 months post-intervention
Change in New York Heart Association (NYHA) Functional Class
This outcome measures the proportion of participants with an improvement (e.g., reduction by one or more classes) in their NYHA functional class, which categorizes the severity of heart failure symptoms and physical limitations.
Measured: From baseline to 6 months post-intervention
Change in Serum NT-proBNP Level
This outcome measures the absolute or percent change in serum N-terminal pro-B-type natriuretic peptide concentration, a biomarker associated with cardiac wall stress and heart failure severity.
Measured: From baseline to 6 months post-intervention
Change in Quality of Life Total Score (SF-36)
This outcome measures the change in overall health-related quality of life using the total score of the 36-Item Short Form Health Survey (SF-36), which covers physical and mental health domains.
Measured: From baseline to 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start7 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCM - Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a two-arm, parallel-group, randomized controlled trial model. Eligible participants are randomly assigned in a 1:1 ratio to one of two parallel treatment arms. Both arms receive their assigned intervention (active drug or matched placebo) concurrently over the same fixed period of 6 months, followed by a common follow-up schedule. The outcomes are compared between these independent, parallel groups at pre-defined time points.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294495
- Sponsor's protocol ID
- 2025286
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) collected and generated in this study, including de-identified datasets, will not be made publicly available. The data are primarily used to fulfill the pre-specified objectives of this investigator-initiated trial. Data may be disclosed to regulatory authorities upon request for audit or review purposes, or for validating key findings in future scientific collaborations under strict data use agreements. However, there is no current plan for systematic public sharing or deposition in a public repository.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07294495
- Acronym / sponsor ID
- 2025286
- Conditions
- HCM - Hypertrophic Cardiomyopathy
- Keywords
- PET/MR, FAPI, Hypertrophic Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 7 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study employs a two-arm, parallel-group, randomized controlled trial model. Eligible participants are randomly assigned in a 1:1 ratio to one of two parallel treatment arms. Both arms receive their assigned intervention (active drug or matched placebo) concurrently over the same fixed period of 6 months, followed by a common follow-up schedule. The outcomes are compared between these independent, parallel groups at pre-defined time points.
| Arm | Type | Receives |
|---|---|---|
| Henagliflozin (SGLT2 Inhibitor) | Experimental | Drug: Henagliflozin (SGLT2 Inhibitor)Participants randomized to this arm will receive a once-daily oral dose of Henagliflozin (10 mg tablet) for a total intervention period of 6 months. Henagliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor. All participants will continue their stable standard background therapy for hypertrophic cardiomyopathy throughout the study. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to this arm will receive a once-daily oral dose of a matching placebo tablet for a total intervention period of 6 months. The placebo is identical in appearance, packaging, and administration schedule to the active drug. All participants will continue their stable standard background therapy for hypertrophic cardiomyopathy throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 years or older, regardless of gender.
- Meets the diagnostic criteria for non-obstructive hypertrophic cardiomyopathy (HCM):
- Willing to undergo FAPI PET/CMR examination and complete imaging evaluations.
- Baseline FAPI PET/CMR scan shows positive FAPI uptake: myocardial FAPI target-to-background ratio (TBR) ≥1.3, using the ascending aorta blood pool as the background reference.
- Capable of understanding and signing the informed consent form, and agrees to participate in the study, accept randomization, and comply with follow-up visits.
Key exclusion criteria (14 listed)
- Significant left ventricular outflow tract obstruction (resting or provoked LVOT pressure gradient ≥30 mmHg).
- Coexistence of other identifiable causes of myocardial hypertrophy, including:
- Overt decompensated heart failure or NYHA functional class IV.
- Unstable, serious arrhythmias (e.g., sustained ventricular tachycardia, recent cardioversion for atrial fibrillation).
- Recent (within 3 months) cardiac surgery or interventional procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Henagliflozin (SGLT2 Inhibitor)This intervention involves the oral administration of Henagliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, at a dose of 10 mg once daily for a period of 6 months. Henagliflozin is provided as a film-coated tablet identical in appearance to the matched placebo used in the control arm. The intervention is administered in a double-blind manner as an add-on to stable standard background therapy for non-obstructive hypertrophic cardiomyopathy. This study specifically investigates the potential anti-fibrotic effects of Henagliflozin on active myocardial fibrosis, as quantified by novel FAPI PET/CMR imaging, in a patient population without diabetes mellitus. | Drug | Henagliflozin (SGLT2 Inhibitor) |
| PlaceboThis intervention involves the oral administration of a matched placebo tablet once daily for a period of 6 months. The placebo is manufactured to be identical in appearance (size, shape, color, coating), packaging, and administration schedule to the active comparator, Henagliflozin 10 mg tablet. It contains no active pharmaceutical ingredient. The intervention is administered in a double-blind manner as an add-on to stable standard background therapy for non-obstructive hypertrophic cardiomyopathy, serving as the control to isolate and evaluate the specific pharmacological effects of the SGLT2 inhibitor. | Drug | Placebo |
Primary outcome
Change in Myocardial FAPI Target-to-Background Ratio (ΔTBR)
Time frame: From baseline to 6 months post-intervention
The primary outcome is the change in myocardial FAPI uptake quantified by the target-to-background ratio (TBR) on FAPI PET/CMR imaging. TBR is calculated as the ratio of the mean standardized uptake value (SUVmean) in the myocardium to that in the ascending aortic blood pool. The difference in TBR from baseline to 6 months post-intervention (ΔTBR) will be compared between the Henagliflozin and placebo groups. This measure directly reflects changes in active fibroblast activity and myocardial fibrosis burden.
10 secondary outcomes
Change in Myocardial FAPI Maximum Standardized Uptake Value (ΔSUVmax)
Time frame: From baseline to 6 months post-intervention
Change in FAPI Activity Volume Percentage (ΔFAV%)
Time frame: From baseline to 6 months post-intervention
Change in Left Ventricular Ejection Fraction (ΔLVEF)
Time frame: From baseline to 6 months post-intervention
Change in Left Ventricular Mass Index (ΔLVMi)
Time frame: From baseline to 6 months post-intervention
Change in Late Gadolinium Enhancement Extent (ΔLGE)
Time frame: From baseline to 6 months post-intervention
Change in Global Longitudinal Strain (ΔGLS)
Time frame: From baseline to 6 months post-intervention
Change in 6-Minute Walk Distance (Δ6MWD)
Time frame: From baseline to 6 months post-intervention
Change in New York Heart Association (NYHA) Functional Class
Time frame: From baseline to 6 months post-intervention
Change in Serum NT-proBNP Level
Time frame: From baseline to 6 months post-intervention
Change in Quality of Life Total Score (SF-36)
Time frame: From baseline to 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) collected and generated in this study, including de-identified datasets, will not be made publicly available. The data are primarily used to fulfill the pre-specified objectives of this investigator-initiated trial. Data may be disclosed to regulatory authorities upon request for audit or review purposes, or for validating key findings in future scientific collaborations under strict data use agreements. However, there is no current plan for systematic public sharing or deposition in a public repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Henagliflozin (SGLT2 Inhibitor) in people with HCM - Hypertrophic Cardiomyopathy, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Ding, MD. (86-021-38804518, dingjie940406@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Myocardial FAPI Target-to-Background Ratio (ΔTBR) (time frame: From baseline to 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.