BridgeMD
New treatment option for Decompensated Cirrhosis
Official title Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival
ClinicalTrials.gov ID: NCT06431919
What this study is testing
What is Simvastatin 20mg?
Simvastatin 20mg is an investigational medicine, being studied as a potential treatment for decompensated cirrhosis.
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
- Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections. Rationale: Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including ascites, variceal bleeding, acute kidney injury, and susceptibility to infections.
- 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
- Compensated cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings,
- CCM (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
- Patient previously treated with statin (one month before the study)
- Contraindications to statins
- Advanced Cirrhosis (CTP score\>9)
- Coronary artery disease
See the full eligibility criteria
- Age range of 18-65 years
- Compensated cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings,
- CCM (with EF\>50%) on 2D echocardiography with TDI
- Written informed consent.
- Age \>65 years
- Serum Creatinine\>2 mg/dl
- Patient previously treated with statin (one month before the study)
- Contraindications to statins
- Advanced Cirrhosis (CTP score\>9)
- Coronary artery disease
- Sick sinus syndrome/ Pacemaker, valvular heart disease
- Cardiac rhythm disorder, Peripartum cardiomyopathy
- Portopulmonary hypertension/ hepatopulmonary syndrome
- Transjugular intrahepatic portosystemic 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 6 months.
- Need for medications, metabolized by CYP3A4(such as amlodipine, verapamil, fenofibrate azole antibiotics, protease inhibitors etc.)
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.