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New treatment option for Cirrhotic Cardiomyopathy
Official title DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis
ClinicalTrials.gov ID: NCT07322237
What this study is testing
What is Empagliflozin + Carvedilol?
Empagliflozin + Carvedilol is an investigational medicine, given as an once-weekly, being studied as a potential treatment for cirrhotic cardiomyopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chandigarh, India
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandigarh, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.