Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-04-22 @ 11:45 PM
Study NCT ID:
NCT02294292
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2014-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Approach to Diastolic Dysfunction in Chronic Liver Disease Patients and Its Impact on Morbidity and Mortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077261', 'term': 'Carvedilol'}, {'id': 'D000077550', 'term': 'Ivabradine'}], 'ancestors': [{'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': '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': 'D001552', 'term': 'Benzazepines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2014-06-09', 'studyFirstSubmitQcDate': '2014-11-18', 'lastUpdatePostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression of cirrhosis and its complications.', 'timeFrame': '1 Year'}], 'secondaryOutcomes': [{'measure': 'Improvement in left ventricular diastolic function in either arm.', 'timeFrame': '1 Year'}, {'measure': 'Renal function', 'timeFrame': '1 Year', 'description': 'Renal function is being checked- urea, creatinine, urine sediment, and creatinine clearance as calculated by Cockcroft - Gault formula'}, {'measure': 'Serum level of Brain Natriuretic Peptide.', 'timeFrame': '1 Year'}, {'measure': 'Mortality', 'timeFrame': '1 Year'}, {'measure': 'Quality of life', 'timeFrame': '1 Year'}, {'measure': 'Electrophysiologic modifications', 'timeFrame': '1 Year', 'description': 'Electrophysiological changes checked are QTc interval, documentation of arrhythmias'}, {'measure': 'Serum level of catecholamines', 'timeFrame': '1 year'}, {'measure': 'Serum level of plasma renin activity', 'timeFrame': '1 Year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diastolic Dysfunction', 'Chronic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '31305281', 'type': 'DERIVED', 'citation': 'Premkumar M, Rangegowda D, Vyas T, Khumuckham JS, Shasthry SM, Thomas SS, Goyal R, Kumar G, Sarin SK. Carvedilol Combined With Ivabradine Improves Left Ventricular Diastolic Dysfunction, Clinical Progression, and Survival in Cirrhosis. J Clin Gastroenterol. 2020 Jul;54(6):561-568. doi: 10.1097/MCG.0000000000001219.'}]}, 'descriptionModule': {'briefSummary': 'Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset of complications in liver disease. The purpose of this prospective, randomized controlled trial is to determine whether carvedilol can revert cardiac dysfunction i.e. left ventricular diastolic dysfunction secondary to cirrhosis, and prevent complications (renal dysfunction, worsening cardiac function, and mortality).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with cirrhosis who have been diagnosed by clinical, biochemical,or histological (when available) criteria plus ultrasound imaging.\n\n* Age range of 18-60 years\n* Cirrhosis as diagnosed by histology or clinical, laboratory and USG (UltraSonography) findings,\n* Upper GI bleed who are undergoing secondary endoscopic variceal ligation for eradication of varices\n\nExclusion Criteria:\n\n* Age \\>60 years\n* Chronic renal disease\n* Pregnancy and peripartum cardiomyopathy\n* Hypertension\n* Coronary artery disease\n* Valvular heart disease\n* Sick sinus syndrome/ Pacemaker\n* Cardiac rhythm disorder\n* Hypothyroidism\n* Hyperthyroidism\n* Portal vein thrombosis\n* Transjugular intrahepatic porto systemic shunt (TIPS) insertion\n* Hepatocellular carcinoma\n* Anemia Hb \\< 8gm/dl in females, and \\< 9 gm/dl in males'}, 'identificationModule': {'nctId': 'NCT02294292', 'briefTitle': 'Therapeutic Approach to Diastolic Dysfunction in Chronic Liver Disease Patients and Its Impact on Morbidity and Mortality', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': "Therapeutic Approach to Diastolic Dysfunction in Chronic Liver Disease Patients and Its' Impact on Morbidity and Mortality", 'orgStudyIdInfo': {'id': 'ILBS-CLD-DD-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carvedilol + Ivabradine', 'description': 'Carvedilol started to achieve target HR (heart rate) reduction to 60/min, to a lowest permissible 50-55/ min ; provided Systolic Blood Pressure\\> 90 mmHg.\n\nif carvedilol is not tolerated,Ivabradine is added in a dose starting 2.5 mg BD to a maximum of 15 mg/day to ensure targeted heart rate reduction', 'interventionNames': ['Drug: Carvedilol', 'Drug: Ivabradine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endoscopic Variceal Ligation (EVL)', 'interventionNames': ['Procedure: Endoscopic Variceal Ligation']}], 'interventions': [{'name': 'Carvedilol', 'type': 'DRUG', 'description': 'Carvedilol started to achieve target HR (heart rate) reduction to 60/min, to a lowest permissible 50-55/ min ; provided Systolic Blood Pressure\\> 90 mmHg.', 'armGroupLabels': ['Carvedilol + Ivabradine']}, {'name': 'Ivabradine', 'type': 'DRUG', 'description': 'Carvedilol started to achieve target HR (heart rate) reduction to 60/min, to a lowest permissible 50-55/ min ; provided Systolic Blood Pressure\\> 90 mmHg.\n\nIf carvedilol is not tolerated,Ivabradine is added in a dose starting 2.5 mg BD to a maximum of 15 mg/day to ensure targeted heart rate reduction', 'armGroupLabels': ['Carvedilol + Ivabradine']}, {'name': 'Endoscopic Variceal Ligation', 'type': 'PROCEDURE', 'armGroupLabels': ['Endoscopic Variceal Ligation (EVL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Institute of Liver & Biliary Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}