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Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 65

Diastolic improvement with carvedilol and empagliflozin for people with cirrhosis

Official title: 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

Run by Post Graduate Institute of Medical Education and Research, Chandigarh · NCT07322237 · Data updated 2026-11-12

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.

More Cirrhosis trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment400 (estimated)
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh
Academic / other
Locations1 site (Chandigarh)
StatusRecruiting
StartedApril 1, 2026
Main results expectedJanuary 30, 2029
Study endsJune 30, 2029
Registry record updatedMay 14, 2026
Trial IDNCT07322237 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • PGIMER Chandigarh
    Chandigarh, India     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.