The Effect of Dapagliflozin on Myocardial Strain in Patients With Acute Heart Failure

NCT07403955 | Not Yet Recruiting

• 1 other identifier: KYLL-202505-110-2
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• left ventricular global longitudinal strain (LVGLS)

  the change in LVGLS from baseline

  at 3 months

Secondary Outcomes (3)

• left ventricular global longitudinal strain (LVGLS)

  at 1 month and 3 months

• peak atrial contraction strain（PACS），peak atrial longitudinal strain（PALS），right ventricular global longitudinal strain（RVGLS）

  at 1 month and 3 months

• all-cause mortality， Cardiovascular death， Heart failure hospitalization

  at 1 month and 3 months

Other Outcomes (1)

• NYHA functional class, NT-proBNP

  at baseline, 1month and 3 months

Study Arms (2)

intervention group

EXPERIMENTAL

Standard treatment combined with dapagliflozin tablet 10mg qd for 3 months

Drug: Dapagliflozin 10mg Tab

control group

NO INTERVENTION

Dapagliflozin tablet 10mg qd was added for two months after one month of standard treatment

Interventions

Dapagliflozin 10mg Tab DRUG

Compared with the control group, dapagliflozin is started within the first month after the onset of acute heart failure.

Also known as: Standard Treatment

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Interventions

dapagliflozin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share