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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
India
PGIMER Chandigarh
RECRUITING
Chandigarh
Contact Information
Primary
Madhumita Premkumar, MD DM
drmadhumitap@gmail.com
01722754777
Backup
Madumita Premkumar
01722754777
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 400
Treatments
Active_comparator: Experimental: Empagliflozin + Carvedilol-arm
Experimental: Empagliflozin + Carvedilol-arm~* Empagliflozin fixed dose of 10 mg per day in patients with or without diabetes for 1 year from randomization~* Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate~* Standard Medical Therapy for liver disease as per clinician decision
Active_comparator: Active Comparator: Carvedilol arm
* Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate 10 mg placebo administered once daily.~* Standard Medical Therapy prescribed as per clinician decision
Sponsors
Leads: Post Graduate Institute of Medical Education and Research, Chandigarh

This content was sourced from clinicaltrials.gov