The Effect of Dapagliflozin on Myocardial Strain in Patients With Acute Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapagliflozin 10mg Tab.
- Who it may be relevant to
- Registry conditions: Congestive Heart Failure Acute. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Clinical Study on the Effect of Dapagliflozin on Myocardial Strain in Patients With Acute Heart Failure
Overview
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
Interventions
- Drug Dapagliflozin 10mg Tab
Compared with the control group, dapagliflozin is started within the first month after the onset of acute heart failure.
Primary outcome measures
- left ventricular global longitudinal strain (LVGLS) [Time frame: at 3 months]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07403955 · KYLL-202505-110-2