Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 2:23 PM
Study NCT ID:
NCT06764966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-09
First Post:
2025-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Statin and Beta Blocker Use in Patients with Decompensated Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D001201', 'term': 'Ascites'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2025-01-07', 'studyFirstSubmitQcDate': '2025-01-07', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility- compare the number of participants who discontinued study medication for any reason during the 12-month follow-up period', 'timeFrame': '12 months'}, {'measure': 'Feasibility- compare the number of participants compliant with study treatment', 'timeFrame': '12 months', 'description': 'Participants will be considered compliant if they attend four follow-up visits and consume ≥ 75% of study medication (determined by pill counts)'}], 'secondaryOutcomes': [{'measure': 'Safety - Adverse events', 'timeFrame': '12 months', 'description': 'Rate of reported treatment-related adverse events (muscle pain, muscle injury, liver injury, kidney dysfunction, other)'}, {'measure': 'New Decompensating events', 'timeFrame': '12 months', 'description': 'Rate of new decompensating events (ascites, vatical bleeding, worsening jaundice, or encephalopathy) in each arm, time for development of new decompensating event'}, {'measure': 'Hepatic transaminases levels', 'timeFrame': '12 months', 'description': 'Number of participants with increases in transaminases by more than five times the upper limit of normal'}, {'measure': 'Survival rate', 'timeFrame': '12 months', 'description': 'Rate of survival between the two treatment arms'}, {'measure': 'Transplant-free survival rate', 'timeFrame': '12 months', 'description': 'Number of participants without liver transplant during study participation'}, {'measure': 'Rate of Hepatocellular Carcinoma Diagnosis', 'timeFrame': '12 months', 'description': 'Number of participants developing Hepatocellular Carcinoma over 12 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Decompensated Cirrhosis', 'Decompensated Liver Disease', 'Statins', 'Beta-Blockers', 'Cirrhosis'], 'conditions': ['Decompensated Liver Cirrhosis', 'Cirrhosis', 'Decompensated Cirrhosis of Liver', 'Decompensated Cirrhosis and Ascites']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age of 18 years or older diagnosed with any form of decompensated liver disease defined as ascites, hepatic encephalopathy, or variceal bleed presenting at Charleston Area Medical Center (CAMC) Memorial Hospital or CAMC-Gastroenterology Liver Clinic\n* Currently on an non-selective beta-blockers agreeing to have their liver disease managed by CAMC-Gastroenterology Liver Clinic as an outpatient for the 12-month follow-up period.\n\nExclusion Criteria:\n\n* Any patient \\<18 years of age\n* Patients with hepatocellular carcinoma\n* Patients with ongoing alcohol use (self-reported consumption of more than one alcoholic drink per week)\n* Patients exhibiting high-risk behaviors that could put them at risk for complications including IV substance use and history of medication non-adherence\n* Patients currently on statin therapy\n* Patients with a history of statin intolerance\n* Patients on the waitlist for liver transplantation\n* Patients taking medications with known drug interactions with statins\n* Patients not able to give informed consent or patients belonging to vulnerable categories as the Federal Regulations or Common Rule'}, 'identificationModule': {'nctId': 'NCT06764966', 'briefTitle': 'Statin and Beta Blocker Use in Patients with Decompensated Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'CAMC Health System'}, 'officialTitle': 'A Pilot Study of Statin and Beta Blocker Use in Patients with Decompensated Cirrhosis', 'orgStudyIdInfo': {'id': '24-1117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NSBB plus statin', 'description': 'Atorvastatin 20 mg once daily along with previously prescribed NSBB', 'interventionNames': ['Drug: Atorvastatin 20 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NSBB plus placebo', 'description': 'Placebo once daily along with previously prescribed NSBB', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atorvastatin 20 mg', 'type': 'DRUG', 'description': 'Atorvastatin 20 mg Once Daily with previously prescribed Non Selective Beta-Blocker', 'armGroupLabels': ['NSBB plus statin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Once Daily along with previously prescribed Non Selective Beta Blocker', 'armGroupLabels': ['NSBB plus placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25304', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'contacts': [{'name': 'Nadeem Anwar, MD', 'role': 'CONTACT', 'email': 'nadeem.anwar@vandaliahealth.org', 'phone': '304-351-1700'}, {'name': 'Nadeem Anwar, MD', 'role': 'CONTACT'}], 'facility': 'Charleston Area Medical Center', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}], 'centralContacts': [{'name': 'Nadeem Anwar, MD', 'role': 'CONTACT', 'email': 'nadeem.anwar@vandaliahealth.org', 'phone': '304-351-1700'}], 'overallOfficials': [{'name': 'Nadeem Anwar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CAMC Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CAMC Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Section Chair, Gastroenterology', 'investigatorFullName': 'Nadeem Anwar', 'investigatorAffiliation': 'CAMC Health System'}}}}