Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT06298656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065290', 'term': 'Acute-On-Chronic Liver Failure'}], 'ancestors': [{'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2024-03-01', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Complications [PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect] within 90 days', 'timeFrame': '90 days'}, {'measure': 'Transplant-free survival rate at 90 days', 'timeFrame': '90 days'}, {'measure': 'Correlation with evolution of AARC score by 2 week', 'timeFrame': '2 week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute-On-Chronic Liver Failure']}, 'descriptionModule': {'briefSummary': 'Clinically significant portal hypertension (CSPH) is defined as HVPG \\>10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality (1). HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers (2). Non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to \\<12 mm Hg or reduction to \\>20% from baseline have been shown to be associated with reduced long term risk of variceal bleed. Hence we are planning the current work to study the Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients - "ACT - C ACLF study', 'detailedDescription': 'To assess whether Acute hemodynamic response to oral Carvedilol can predict short term outcome in ACLF patients.\n\n• To determine the best cut off to define acute hemodynamic response in ACLF patients\n\nPrimary outcome - Predictive value of acute HVPG change by carvedilol for 28 day transplant free survival in patients of ACLF\n\nSecondary outcome -\n\n(1) Complications \\[PHT related bleed, AKI, infections, HE, Hypotension, Cardiac side effect\\] within 90 days (2) Transplant-free survival rate at 90 days (3) Correlation with evolution of AARC score by 2 week\n\n(b) Methodology\n\nStudy population: Patients of age 18 to 70 years with ACLF fulfilling the conditions as per inclusion and exclusion criteria\n\nBaseline parameters that will be recorded:\n\n1. Baseline characteristics:\n2. History and etiology of liver disease\n3. Symptomatology, Evidence of decompensation (jaundice, encephalopathy, ascites, infections, variceal bleed etc)\n4. Clinical and demographic profile\n5. Endoscopy\n\nStopping rule of study:\n\n1. Progression to exclusion criteria\n2. In case of hypotension(\\<90/60mmHg) or Heart Rate \\<60 after carvedilol\n3. Potential liver transplant within 90 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of age 18 to 70 years with ACLF fulfilling the conditions as per inclusion and exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-70 yrs\n2. ACLF diagnosis (AARC criteria)\n\nExclusion Criteria:\n\n1. Contraindications to NSBB (Heart rate \\< 65 /min, BP \\< 110/65 mm Hg, Asthma, Heart failure, AKI, Large ascites, SBP, S. Na \\< 125meq/l)\n2. PVT\n3. HCC\n4. BCS\n5. HE grades 2-4\n6. NSBB therapy within 5 days\n7. Pregnancy\n8. Lactation\n9. Planned for LT in the next 12 weeks\n10. No consent.'}, 'identificationModule': {'nctId': 'NCT06298656', 'briefTitle': 'Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients - "ACT - C ACLF Study', 'orgStudyIdInfo': {'id': 'ILBS-ACLF-17'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'It is an observational study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'contacts': [{'name': 'Garvit Mundra, MD', 'role': 'CONTACT', 'email': 'garvitmundrailbs@gmail.com', 'phone': '01146300000'}], 'facility': 'Institute of Liver & Biliary Sciences (ILBS)', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'centralContacts': [{'name': 'Dr Garvit Mundra, MD', 'role': 'CONTACT', 'email': 'garvitmundrailbs@gmail.com', 'phone': '01146300000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}