DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis
Recruiting · NCT07322237 · Interventional (participants receive a specific treatment) · Lead sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
1. This proposed double-blind placebo controlled randomized controlled trial incorporates recent advances in management of heart failure and portal hypertension using the SGLT-2 inhibitor i.e. EMPAGLIFLOZIN. The drug has been found to be useful in large trials on heart failure with preserved ejection fraction in the general population with improvement in MASLD progression, with improvement in body weight and hepatic steatosis but no change in liver fibrosis. 2. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been shown to reduce the development and progression of heart failure in patients with type 2 diabetes and in those with heart failure and a reduced and preserved ejection fraction. In patients with cirrhosis safety of empagliflozin in a dose of 10 mg has been demonstrated. 3. Prevention of decompensation related events in cirrhosis is the key endpoint of any liver-directed therapy as the median survival in the compensated state exceeds 10 years but median survival in the decompensated state approximates 1.5 years. Previous data has demonstrated the risk of hepatic decompensation acute kidney injury and poor survival in patients with cirrhosis and heart failure with preserved ejection fraction (HFpEF) i.e. LVDD a large subset of whom meet criteria for CCM.
Who can take part
Inclusion criteria
- Age range of 18-65 years
- Cirrhosis as diagnosed by histology or clinical laboratory and USG findings
- LVDD (with EF\>50%) on 2D echocardiography with TDI
- Written informed consent.
Exclusion criteria
- Age \>65 years
- Serum Creatinine\>2 mg/dl
- History of urinary tract /genital infections in last 3 months
- Patient on treatment with statin (one month before the study)
- Advanced Cirrhosis (MELD\>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 \< 8gm/dl in females and \< 9 gm/dl in males
- Acute variceal bleeding in last 6months.
Where it is running
1 location listed.
- PGIMER Chandigarh - Chandigarh, India