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The study of the effect and molecular mechanism of empagliflozin in patients with metabolic associated fatty liver disease combined with hypertension based on multi-omics technology and multi-center clinical research

The study of the effect and molecular mechanism of empagliflozin in patients with metabolic associated fatty liver disease combined with hypertension based on multi-omics technology and multi-center clinical research

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111223
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-06-20
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension ,metabolic associated fatty liver disease

Interventions

Experimental Group:Take engagliflozin 10mg orally once a day for one year. The treatment of hypertension for patients should be carried out in accordance with the corresponding guidelines and norms
Control group:In addition to treating the patients underlying diseases, including hypertension, empagliflozin should not be added. The selection of antihypertensive drug categories is not restricted.

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Sign the informed consent form for the patient and indicate the date of signing 2. The place of residence is relatively stable and can meet the requirements for follow-up during the clinical research period 3. Be over 18 years old 4. Patients with clinically confirmed hypertension combined with MAFLD: Newly diagnosed hypertensive patients with three or more blood pressure >=140/90 MMHG as the diagnostic criteria for hypertension, and/or those with previously confirmed hypertension (regardless of whether they are taking antihypertensive drugs or not), excluding secondary hypertension. 5. Receive standardized treatment in accordance with the corresponding guidelines for hypertension and MAFLD diseases.

Exclusion criteria

Exclusion criteria: 1.Secondary hypertension 2. Has a history of heavy alcohol consumption and has been diagnosed with alcoholic fatty liver disease 3. There are other liver diseases, including hepatitis B (positive for serum hepatitis B surface antigen), hepatitis C (positive for anti-hepatitis C virus), autoimmune hepatitis (positive for autoimmune serology and consistent with biopsy specimens), drug-induced liver diseases based on exposure and medical history, and biliary obstruction based on imaging studies; A history of gastrointestinal bypass or the use of drugs known to cause hepatic steatosis (such as amiodarone, sodium valproate, tamoxifen, methotrexate, steroids); The latest initiation or changes of antidiabetic drugs that affect liver fat (including thiazolidinedione and glucagon-like peptide 1 receptor agonists); Evidence of liver cirrhosis (based on ultrasound and MRI[no patient suspected of liver cirrhosis according to clinical and biochemical features]) or evidence of hepatocellular carcinoma (MRI evidence); HIV test positive; Abuse of active substances; Pregnant or planning to become pregnant; Renal insufficiency (glomerular filtration rate, estimated to be <45 mL/min/1.73 m^2 according to the MDRD equation); Contraindications for the use of engagliflozin (history of recurrent urinary or genital infections, current or previous gangrene, or known history of allergy to the molecule). 4. Hypertrophic cardiomyopathy, dilated cardiomyopathy, etc 5. Suffer from a serious mental illness 6. Pre-existing severe heart failure (grade III-IV) 7. Structural heart valve diseases have been identified, such as moderate to severe valvular regurgitation and moderate to severe valvular stenosis 8. Patients with diseases that can cause significant changes in heart structure, such as myocardial infarction, after heart surgery, atrial fibrillation, etc., are found. 9. Severe chronic obstructive pulmonary disease, etc. 10. Patients with tumors or with an expected lifespan of less than one year due to other diseases 11. Other clinical studies that may affect the purpose of the research have been registered for inclusion

Design outcomes

Primary

MeasureTime frame
Relative wall thickness;Left ventricular mass index;Left atrial volume index;

Secondary

MeasureTime frame
Left ventricular ejection fraction;Liver fat content;Incidence of adverse reactions;Incidence of the composite endpoint of major cardiovascular events;

Countries

China

Contacts

Public ContactZhouqing Huang

The First Affiliated Hospital of Wenzhou Medical University

susiehzq@126.com+86 577 5557 9281

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026