Diastolic improvement with carvedilol and empagliflozin for people with cirrhosis
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
This test will see if adding empagliflozin to carvedilol improves diastolic heart function and reduces decompensation events in adults with cirrhosis and left ventricular diastolic dysfunction.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh Academic / other |
| Locations | 1 site (Chandigarh) |
| Trial ID | NCT07322237 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 4 trial comparing carvedilol plus empagliflozin versus carvedilol alone in adults (18–65) with cirrhosis and echocardiographic left ventricular diastolic dysfunction. Participants are assessed using updated cirrhotic cardiomyopathy criteria (including septal e', E/e', LAVI, TR velocity and GLS) and monitored for cardiac function, liver decompensation events, and safety. Empagliflozin has established benefits in heart failure populations and a 10 mg dose has shown safety in patients with cirrhosis; this trial applies that approach to prevent cirrhosis-related decompensation. Key exclusions include advanced cirrhosis (MELD >20), significant renal impairment, coronary artery disease, TIPS, hepatocellular carcinoma, recent serious infections, and pregnancy.
Who should consider this trial
Good fit: Ideal candidates are adults 18–65 with compensated cirrhosis (by histology or clinical/USG findings), echocardiographic LV diastolic dysfunction with preserved EF, and who meet safety labs and consent requirements.
Not a fit: Patients with advanced cirrhosis (MELD >20), significant renal impairment, active cardiac disease (e.g., coronary artery disease, reduced EF), TIPS, hepatocellular carcinoma, recent severe infections, pregnancy, or on contraindicated medications are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this approach could lower the risk of liver decompensation and improve diastolic heart function and related symptoms in compensated cirrhosis.
How similar studies have performed: Large trials of SGLT2 inhibitors have reduced heart-failure events in patients with preserved and reduced EF and empagliflozin has been used safely in cirrhosis, but combining empagliflozin with carvedilol specifically to prevent cirrhosis decompensation is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chandigarh
- PGIMER Chandigarh — Chandigarh, India (Recruiting)
Study contacts
- Study coordinator: Madhumita Premkumar, MD DM
- Email: drmadhumitap@gmail.com
- Phone: 01722754777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.