Tests empagliflozin with carvedilol in people with cirrhosis and heart stiffness
Tests empagliflozin added to carvedilol in adults with cirrhosis and diastolic heart dysfunction.
Plain-language title generated from the registry record
Registry title: DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis
Key facts
- Where
- Chandigarh, IndiaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07322237, who can take part
Where in India
- PGIMER ChandigarhChandigarh, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Trial code
- NCT07322237
- Record updated
- 14 May 2026
- Original description
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.Read full original descriptionShow less
Empagliflozin + Carvedilol vs. Carvedilol Alone for Patients With Cirrhosis and Left Ventricular Diastolic Dysfunction and Impact on Hepatic Decompensation and Survival: A Double-Blind Placebo-Controlled Randomized Controlled Trial
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.
Inclusion: 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: Patient on treatment with statin (one month before the study); History of urinary tract /genital infections in last 3 months; Coronary artery disease; Sick sinus syndrome/ Pacemaker valvular heart disease; Cardiac rhythm disorder Peripartum cardiomyopathy; Portopulmonary hypertension/ hepatopulmonary syndrome; Patients with HIV or retroviral therapy; Acute variceal bleeding in last 6months; Serum Creatinine>2 mg/dl; Age >65 years; Advanced Cirrhosis (MELD>20); Transjugular intrahepatic porto systemic shunt (TIPS) insertion; Hepatocellular carcinoma; Pregnancy or lactation; Anemia Hb < 8gm/dl in females and < 9 gm/dl in males.