Health Condition 1: - Health Condition 2: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: Empagliflozin + Carvedilol: Empagliflozin fixed dose of 10 mg per day Orally for one year Carvedilol: Starting dose of 3.125 mg twice daily
targeted upwards q 7 days to achieve target h
Sponsors
Post Graduate Institute of Medical Education & Research, Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: Age range of 18 to 65 years Cirrhosis as diagnosed by histology or clinical laboratory and USG findings LVDD with EF less than 50 percent on 2D echocardiography with TDI Written informed consent
Exclusion criteria
Exclusion criteria: Age more than 65 years Serum Creatinine more than 2 mgperdl History of urinary tract genital infections in last 3 months Patient on treatment with statin one month before the study Advanced Cirrhosis MELD more than 20 Coronary artery disease Sick sinus syndrome Pacemaker valvular heart disease Cardiac rhythm disorder, Peripartum cardiomyopathy Portopulmonary hypertension hepatopulmonary syndrome Transjugular intrahepatic porto systemic shunt TIPS insertion Hepatocellular carcinoma Pregnancy or lactation Patients with HIV or retroviral therapy Anemia Hb less than 8gmperdl in females and less than 9 gmperdl in males Acute variceal bleeding in last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) The primary outcome measure is defined as a composite end point of hospitalization for acute decompensation event or heart failure, and/or all cause death in the participants.Timepoint: a) The primary outcome measure is defined as a composite end point of hospitalization for acute decompensation event or heart failure, and/or all cause death in the participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Improvement in cirrhotic cardiomyopathy parameters (left ventricular diastolic function) in either arm based on Echocardiography and Cardiac Imaging. b) Any episodes which warranted hospitalization of the participants. c) Serum level of BNP and other cardiac and inflammatory biomarkers will be assessed and correlated clinically. d) Assessment of liver related or cardiac associated causes of hospitalization or death in either arm. Timepoint: 1 Year | — |
Countries
India
Contacts
Public ContactPrena Sharma
Post Graduate Institute of Medical Education and Research Chandigarh
Outcome results
None listed