Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT03720067
Status:
UNKNOWN
Last Update Posted:
2019-05-14
First Post:
2018-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Propranolol, Carvedilol and Rosuvastatin in the Prevention of Variceal Bleeding in Cirrhotic Portal Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011433', 'term': 'Propranolol'}, {'id': 'D000077261', 'term': 'Carvedilol'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-12', 'studyFirstSubmitDate': '2018-10-23', 'studyFirstSubmitQcDate': '2018-10-23', 'lastUpdatePostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute hemodynamic response', 'timeFrame': 'Two hours after a load dose of carvedilol or propranolol', 'description': 'A decrease in HVPG to 12 mmHg or lower'}, {'measure': 'Full hemodynamic response to beta blockers', 'timeFrame': 'Eight weeks of carvedilol or propranolol', 'description': 'A decrease in HVPG to 12 mmHg or lower'}, {'measure': 'Full hemodynamic response to beta blockers plus rosuvastatin or placebo', 'timeFrame': 'Eight weeks of beta blockers plus rosuvastatin or placebo', 'description': 'A decrease in HVPG to 12 mmHg or lower'}], 'secondaryOutcomes': [{'measure': 'Sufficient hemodynamic response to beta blockers plus rosuvastatin or placebo', 'timeFrame': 'Eight weeks of beta blockers plus rosuvastatin or placebo', 'description': 'A decrease in HVPG of at least 20% from baseline'}, {'measure': 'Partial hemodynamic response to beta blockers plus rosuvastatin or placebo', 'timeFrame': 'Eight weeks of beta blockers plus rosuvastatin or placebo', 'description': 'A decrease in HVPG of at least 10% from baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cirrhosis', 'Portal Hypertension', 'Variceal Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Patients with hepatic cirrhosis and previous variceal bleeding will be randomly assigned to use propranolol or carvedilol. After 8 weeks, rosuvastatin or placebo will be blindly added to nonresponders (HVPG measurement \\> 12mmHg) for another 8 weeks and hemodynamic response will be assessed again.\n\nSurrogate serum markers of portal hypertension will be evaluated and correlated to HVPG values and to its variations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hepatic cirrhosis of any etiology\n* Previous variceal bleeding\n* Endoscopic variceal eradication at least 2 weeks before\n\nExclusion Criteria:\n\n* Beta blocker or statin contraindications\n* Model for End-Stage Liver Disease (MELD) score \\> 25\n* Child-Pugh score \\> 13\n* HVPG ≤ 12 mmHg\n* Creatinine clearance \\< 50 mL/min\n* Refractory ascites\n* Hepatic encephalopathy stages 3 or 4\n* Alcohol use in the last 6 months\n* Hepatitis C treatment in the last 6 months\n* Changing or initiating a new hepatitis B treatment in the last 6 months\n* Malignant neoplasms from any origin except basal cell carcinoma\n* HIV infection\n* Pregnancy\n* Anticoagulation\n* Recent or complete portal vein thrombosis'}, 'identificationModule': {'nctId': 'NCT03720067', 'acronym': 'Betastatin', 'briefTitle': 'Propranolol, Carvedilol and Rosuvastatin in the Prevention of Variceal Bleeding in Cirrhotic Portal Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio de Janeiro'}, 'officialTitle': 'Propranolol, Carvedilol and Rosuvastatin in the Prevention of Recurrent Variceal Haemorrhage in Patients With Cirrhotic Portal Hypertension', 'orgStudyIdInfo': {'id': '83211318.1.0000.5257'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 1: Propranolol (PPL)', 'description': 'Hepatic venous pressure gradient (HVPG) will be measured before and after 120 minutes of a loading dose of Propranolol (PPL) 80 mg PO. Thereafter, patients will receive maintenance therapy with Propranolol (40 to 320 mg / day) adjusted according to blood pressure and heart rate. After 28 days of reaching the maximum tolerated dose, a new HVPG measurement will be performed.', 'interventionNames': ['Drug: Propranolol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 1: Carvedilol (CVD)', 'description': 'HVPG will be measured before and after 120 minutes of a loading dose of Carvedilol (CVD) 12.5 mg PO. Thereafter, patients will receive maintenance therapy with Carvedilol (6.25 - 25 mg / day) adjusted according to blood pressure. After 28 days of reaching the maximum tolerated dose, a new HVPG measurement will be performed.', 'interventionNames': ['Drug: Carvedilol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2: PPL non-responders/rosuvastatin', 'description': 'Patients treated with PROPRANOLOL (PPL) who do not reach HVPG fall below 12 mmHg will be randomized to receive the addition of ROSUVASTATIN 20 mg /day PO. HVPG will be measured again after 56 days.', 'interventionNames': ['Drug: Propranolol', 'Drug: Rosuvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 2: PPL non-responders/placebo', 'description': 'Patients treated with PROPRANOLOL (PPL) who do not reach HVPG fall below 12 mmHg will be randomized to receive the addition of PLACEBO 1 tablet PO. HVPG will be measured again after 56 days.', 'interventionNames': ['Drug: Propranolol', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase 2: CVD non-responders/rosuvastatin', 'description': 'Patients treated with CARVEDILOL (CVD) who do not reach HVPG fall below 12 mmHg will be randomized to receive the addition of ROSUVASTATIN 20 mg /day PO. HVPG will be measured again after 56 days.', 'interventionNames': ['Drug: Carvedilol', 'Drug: Rosuvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 2: CVD non-responders/placebo', 'description': 'Patients treated with CARVEDILOL (CVD) who do not reach HVPG fall below 12 mmHg will be randomized to receive the addition of PLACEBO 1 tablet PO. HVPG will be measured again after 56 days.', 'interventionNames': ['Drug: Carvedilol', 'Drug: Placebo']}], 'interventions': [{'name': 'Propranolol', 'type': 'DRUG', 'description': '40mg to 320mg / day', 'armGroupLabels': ['Phase 1: Propranolol (PPL)', 'Phase 2: PPL non-responders/placebo', 'Phase 2: PPL non-responders/rosuvastatin']}, {'name': 'Carvedilol', 'type': 'DRUG', 'description': '6.25mg to 25mg / day', 'armGroupLabels': ['Phase 1: Carvedilol (CVD)', 'Phase 2: CVD non-responders/placebo', 'Phase 2: CVD non-responders/rosuvastatin']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'description': '20mg / day', 'armGroupLabels': ['Phase 2: CVD non-responders/rosuvastatin', 'Phase 2: PPL non-responders/rosuvastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo of rosuvastatin', 'armGroupLabels': ['Phase 2: CVD non-responders/placebo', 'Phase 2: PPL non-responders/placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rio de Janeiro', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Guilherme FM Rezende, MD, PhD', 'role': 'CONTACT', 'email': 'guimottarezende@gmail.com', 'phone': '55-21-999976292'}, {'name': 'Andre Luiz M Torres, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universidade Federal do Rio de Janeiro', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'centralContacts': [{'name': 'Guilherme FM Rezende, MD, PhD', 'role': 'CONTACT', 'email': 'guimottarezende@gmail.com', 'phone': '(5521)999976292'}, {'name': 'Andre Luiz M Torres, MD', 'role': 'CONTACT', 'email': 'torres.alm@gmail.com', 'phone': '(5521)998588246'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio de Janeiro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'Guilherme Rezende', 'investigatorAffiliation': 'Universidade Federal do Rio de Janeiro'}}}}