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

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:

• 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 Overview

• Status: Not yet recruiting
• Conditions: Congestive Heart Failure Acute
• Intervention / Treatment: Drug: Dapagliflozin 10mg Tab

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; Standard treatment combined with dapagliflozin tablet 10mg qd for 3 months	Drug: Dapagliflozin 10mg Tab; Compared with the control group, dapagliflozin is started within the first month after the onset of acute heart failure.; Other Names: Standard Treatment
No Intervention: control group; Dapagliflozin tablet 10mg qd was added for two months after one month of standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
left ventricular global longitudinal strain (LVGLS)	the change in LVGLS from baseline	at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
left ventricular global longitudinal strain (LVGLS)	the change in LVGLS from baseline	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	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	at 1 month and 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
NYHA functional class, NT-proBNP	NYHA functional class and the level of NT-proBNP	at baseline, 1month and 3 months

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: dapagliflozin
• Other Study ID Numbers: KYLL-202505-110-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No