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NCT Number: NCT07403955

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin 10mg Tab

Drug

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

Other names: Standard Treatment

Primary outcomes

  1. left ventricular global longitudinal strain (LVGLS)

    Time frame: at 3 months

    the change in LVGLS from baseline

Secondary outcomes

  1. left ventricular global longitudinal strain (LVGLS)

    Time frame: at 1 month and 3 months

    the change in LVGLS from baseline

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

    Time frame: at 1 month and 3 months

    the change in PACS, PALS, RVGLS from baseline

  3. all-cause mortality, Cardiovascular death, Heart failure hospitalization

    Time frame: at 1 month and 3 months

    The composite secondary endpoint included all-cause mortality, cardiovascular death or heart failure hospitalization

Other outcomes

  1. NYHA functional class, NT-proBNP

    Time frame: at baseline, 1month and 3 months

    NYHA functional class and the level of NT-proBNP

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

A Randomized Controlled Clinical Study on the Effect of Dapagliflozin on Myocardial Strain in Patients With Acute Heart Failure

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 11, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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