NCT07322237 DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis
| NCT ID | NCT07322237 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh |
| Condition | Cirrhotic Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2029-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2026-04-01 with a primary completion date of 2029-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07322237 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cirrhotic Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07322237 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07322237 currently recruiting?
Yes, NCT07322237 is actively recruiting participants. Contact the research team at drmadhumitap@gmail.com for enrollment information.
Where is the NCT07322237 trial being conducted?
This trial is being conducted at Chandigarh, India.
Who is sponsoring the NCT07322237 clinical trial?
NCT07322237 is sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. The trial plans to enroll 400 participants.