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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin 10mg Tab

    Drug

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

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: intervention groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

left ventricular global longitudinal strain (LVGLS)

the change in LVGLS from baseline

Time frame
at 3 months

Secondary outcomes

1

left ventricular global longitudinal strain (LVGLS)

the change in LVGLS from baseline

Time frame
at 1 month and 3 months
2

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

the change in PACS, PALS, RVGLS from baseline

Time frame
at 1 month and 3 months
3

all-cause mortality, Cardiovascular death, Heart failure hospitalization

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

Time frame
at 1 month and 3 months

Other outcomes

1

NYHA functional class, NT-proBNP

NYHA functional class and the level of NT-proBNP

Time frame
at baseline, 1month and 3 months

Locations

This trial has no locations.

Sponsors and contacts

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