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DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis

RecruitingPhase 4Ages 18 Years - 65 YearsAllPost Graduate Institute of Medical Education and …
NCT07322237 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 th

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📋 Eligibility rules (as published)
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.
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What it tests

  • Empagliflozin + Carvedilol
  • Carvedilol
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Where

1 site
PGIMER Chandigarh
Chandigarh, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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