Congestive Heart Failure AcuteNCT07403955
The Effect of Dapagliflozin on Myocardial Strain in Patients With Acute Heart Failure
A study testing Dapagliflozin 10mg Tab in people with Congestive Heart Failure Acute, run by Qilu Hospital of Shandong University.
Trial summary
The goal of this clinical trial is to assess the impact of dapagliflozin on myocardial strain in patients with acute heart failure using speckle tracking echocardiography (STE). The main questions it aims to answer are: Does dapagliflozin improve left ventricular remodeling as well as cardiac systolic and diastolic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure Acute
- What is being tested?
- Dapagliflozin 10mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to 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
- Informed consent from patient or next of kin； Eighteen years and older; Admitted to hospital due to acute heart failure； eGFR> 25ml /min/1.73m2 (calculated by the MDRD equation)； Eligible patients will be enrolled within 24 hours to 14 days after admission, while still hospitalized and in a stable condition.
Who cannot join
- Type I diabetes mellitus; Systolic blood pressure < 90mmHg at enrollment or positive inotropic drugs are required at enrollment or are expected to be used during hospitalization; Non-cardiac dyspnea； Known hypersensitivity to dapagliflozin； Previous treatment with any SGLT2 inhibitor； History of diabetic ketoacidosis within 3 months； Patients on dialysis； Current atrial fibrillation； Poor echocardiographic images quality prohibiting speckle tracking echocardiography analysis； History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3) or asymptomatic sustained ventricular tachycardia，congenital long QT syndrome, history of QT prolongation associated with other medications that required discontinuation of that medication; Diagnosis of hypertrophic obstructive cardiomyopathy, reversible cardiomyopathy (such as stress cardiomyopathy), cardiac infiltrative diseases (such as myocardial amyloidosis), constrictive pericarditis, severe valvular heart disease (moderate or severe aortic stenosis, severe aortic regurgitation, moderate or severe mitral stenosis, severe mitral regurgitation, heart valve disease expected to undergo surgery during the trial period); Various serious diseases that affect the clinical course of the subjects, such as acute exacerbation of chronic obstructive pulmonary disease and severe liver function impairment (Child-Pugh Grade C), severe anemia (hemoglobin < 90g/L), gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of the test drug, acute or chronic pancreatitis, current urinary or reproductive system infections, and a recorded history of active or suspected malignant tumors or a clear history of malignant tumors within one year prior to screening; Diffuse edema with 4+ edema, estimated blood volume exceeding 40 pounds (18kg); Pregnant, or currently breastfeeding or in the preconception period; Failure to follow the research evaluation schedule for follow-up, or deemed unsuitable for participation by the investigator
About this study
Official title: A Randomized Controlled Clinical Study on the Effect of Dapagliflozin on Myocardial Strain in Patients With Acute Heart Failure
The goal of this clinical trial is to assess the impact of dapagliflozin on myocardial strain in patients with acute heart failure using speckle tracking echocardiography (STE).
The main questions it aims to answer are:
Read more
- Does dapagliflozin improve left ventricular remodeling as well as cardiac systolic and diastolic function?
- Can STE more accurately assess the impact of dapagliflozin on myocardial strain in patients with acute heart failure? Researchers will compare patients receiving oral dapagliflozin to those not receiving it to see if dapagliflozin works to improve left ventricular remodeling as well as cardiac systolic and diastolic function.
Participants will:
- Take dapagliflozin or not every day for 1 month
- Take dapagliflozin for the next 2 months
- Visit the clinic at Month 1 and Month 3 for checkups and tests
- Conditions
- Congestive Heart Failure Acute
- Being tested
- Dapagliflozin 10mg Tab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Also called Standard Treatment
Compared with the control group, dapagliflozin is started within the first month after the onset of acute heart failure.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Standard treatment combined with dapagliflozin tablet 10mg qd for 3 months Receives: Drug: Dapagliflozin 10mg Tab |
| control group | No intervention | Dapagliflozin tablet 10mg qd was added for two months after one month of standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular global longitudinal strain (LVGLS)
the change in LVGLS from baseline
Measured: at 3 months
Secondary outcomes (3)
left ventricular global longitudinal strain (LVGLS)
the change in LVGLS from baseline
Measured: at 1 month and 3 months
peak atrial contraction strain（PACS），peak atrial longitudinal strain（PALS），right ventricular global longitudinal strain（RVGLS）
the change in PACS, PALS, RVGLS from baseline
Measured: at 1 month and 3 months
all-cause mortality， Cardiovascular death， Heart failure hospitalization
The composite secondary endpoint included all-cause mortality, cardiovascular death or heart failure hospitalization
Measured: at 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure AcuteStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403955
- Sponsor's protocol ID
- KYLL-202505-110-2
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Study on the Effect of Dapagliflozin on Myocardial Strain in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT07403955
- Acronym / sponsor ID
- KYLL-202505-110-2
- Conditions
- Congestive Heart Failure Acute
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Feb 2026 (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.
The goal of this clinical trial is to assess the impact of dapagliflozin on myocardial strain in patients with acute heart failure using speckle tracking echocardiography (STE).
The main questions it aims to answer are:
- Does dapagliflozin improve left ventricular remodeling as well as cardiac systolic and diastolic function?
- Can STE more accurately assess the impact of dapagliflozin on myocardial strain in patients with acute heart failure? Researchers will compare patients receiving oral dapagliflozin to those not receiving it to see if dapagliflozin works to improve left ventricular remodeling as well as cardiac systolic and diastolic function.
Participants will:
- Take dapagliflozin or not every day for 1 month
- Take dapagliflozin for the next 2 months
- Visit the clinic at Month 1 and Month 3 for checkups and tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Dapagliflozin 10mg TabStandard treatment combined with dapagliflozin tablet 10mg qd for 3 months |
| control group | No intervention | –Dapagliflozin tablet 10mg qd was added for two months after one month of standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Informed consent from patient or next of kin； Eighteen years and older; Admitted to hospital due to acute heart failure； eGFR> 25ml /min/1.73m2 (calculated by the MDRD equation)； Eligible patients will be enrolled within 24 hours to 14 days after admission, while still hospitalized and in a stable condition.
Key exclusion criteria (1 listed)
- Type I diabetes mellitus; Systolic blood pressure < 90mmHg at enrollment or positive inotropic drugs are required at enrollment or are expected to be used during hospitalization; Non-cardiac dyspnea； Known hypersensitivity to dapagliflozin； Previous treatment with any SGLT2 inhibitor； History of diabetic ketoacidosis within 3 months； Patients on dialysis； Current atrial fibrillation； Poor echocardiographic images quality prohibiting speckle tracking echocardiography analysis； History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3) or asymptomatic sustained ventricular tachycardia，congenital long QT syndrome, history of QT prolongation associated with other medications that required discontinuation of that medication; Diagnosis of hypertrophic obstructive cardiomyopathy, reversible cardiomyopathy (such as stress cardiomyopathy), cardiac infiltrative diseases (such as myocardial amyloidosis), constrictive pericarditis, severe valvular heart disease (moderate or severe aortic stenosis, severe aortic regurgitation, moderate or severe mitral stenosis, severe mitral regurgitation, heart valve disease expected to undergo surgery during the trial period); Various serious diseases that affect the clinical course of the subjects, such as acute exacerbation of chronic obstructive pulmonary disease and severe liver function impairment (Child-Pugh Grade C), severe anemia (hemoglobin < 90g/L), gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of the test drug, acute or chronic pancreatitis, current urinary or reproductive system infections, and a recorded history of active or suspected malignant tumors or a clear history of malignant tumors within one year prior to screening; Diffuse edema with 4+ edema, estimated blood volume exceeding 40 pounds (18kg); Pregnant, or currently breastfeeding or in the preconception period; Failure to follow the research evaluation schedule for follow-up, or deemed unsuitable for participation by the investigator
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 |
|---|---|---|
| Dapagliflozin 10mg TabAlso: Standard TreatmentCompared with the control group, dapagliflozin is started within the first month after the onset of acute heart failure. | Drug | intervention group |
Primary outcome
left ventricular global longitudinal strain (LVGLS)
Time frame: at 3 months
the change in LVGLS from baseline
3 secondary outcomes
left ventricular global longitudinal strain (LVGLS)
Time frame: at 1 month and 3 months
peak atrial contraction strain（PACS），peak atrial longitudinal strain（PALS），right ventricular global longitudinal strain（RVGLS）
Time frame: at 1 month and 3 months
all-cause mortality， Cardiovascular death， Heart failure hospitalization
Time frame: at 1 month and 3 months
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 24 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin 10mg Tab in people with Congestive Heart Failure Acute, run by Qilu Hospital of Shandong University.
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 1 inclusion and 1 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular global longitudinal strain (LVGLS) (time frame: at 3 months). 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 24 Mar 2026.