NCT07322237RecruitingPhase 4
DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients 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
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 30 Nov 2025
- Start date
- 1 Apr 2026
- Primary completion date
- 30 Jan 2029
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Diseases
- Heart failure
- NCT number
- NCT07322237
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 400
- From 1 Apr 2026 to the primary completion date, 30 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient on treatment with statin (one month before the study)
Other illness
- 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.
Lab values
- Serum Creatinine\>2 mg/dl
Age
- Age \>65 years
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PGIMER Chandigarh Coordinator of this site? Confirm its status | Chandigarh | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.