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Decompensated cirrhosis (liver disease) occurs when liver function decreases to the extent that serious complications develop and can include internal bleeding, fluid buildup in the abdomen, or mental confusion. This reduced decreased liver function subsequently decreases life expectancy. There is a critical need for strategies to delay progression to decompensation and reduce the occurrence of serious complications. Currently, limited therapeutic options are available for managing decompensated liver disease, with beta-blockers (BB) being the only proven medication with significant benefits in preventing disease progression. Statins have been historically under- prescribed in cirrhosis due to concerns of liver damage. However, there is emerging evidence that statin use may be beneficial and able to lessen liver disease worsening, with studies demonstrating its safety. Thus, we aim to conduct a pilot randomized controlled trial (RCT) study of 50 subjects comparing the outcomes of decompensated cirrhotic patients receiving the statin, atorvastatin, and a non-selective beta-blocker (NSBB) versus those receiving NSBB plus placebo. Both groups will be followed for 12 months to investigate the feasibility, safety, and efficacy of combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSBB plus statin | Active Comparator | Atorvastatin 20 mg once daily along with previously prescribed NSBB |
|
| NSBB plus placebo | Placebo Comparator | Placebo once daily along with previously prescribed NSBB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 20 mg | Drug | Atorvastatin 20 mg Once Daily with previously prescribed Non Selective Beta-Blocker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility- compare the number of participants who discontinued study medication for any reason during the 12-month follow-up period | 12 months | |
| Feasibility- compare the number of participants compliant with study treatment | Participants will be considered compliant if they attend four follow-up visits and consume ≥ 75% of study medication (determined by pill counts) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Adverse events | Rate of reported treatment-related adverse events (muscle pain, muscle injury, liver injury, kidney dysfunction, other) | 12 months |
| New Decompensating events | Rate of new decompensating events (ascites, vatical bleeding, worsening jaundice, or encephalopathy) in each arm, time for development of new decompensating event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadeem Anwar, MD | Contact | 304-351-1700 | nadeem.anwar@vandaliahealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Nadeem Anwar, MD | CAMC Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charleston Area Medical Center | Recruiting | Charleston | West Virginia | 25304 | United States |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo Once Daily along with previously prescribed Non Selective Beta Blocker |
|
| 12 months |
| Hepatic transaminases levels | Number of participants with increases in transaminases by more than five times the upper limit of normal | 12 months |
| Survival rate | Rate of survival between the two treatment arms | 12 months |
| Transplant-free survival rate | Number of participants without liver transplant during study participation | 12 months |
| Rate of Hepatocellular Carcinoma Diagnosis | Number of participants developing Hepatocellular Carcinoma over 12 months | 12 months |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |