Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-01 @ 11:35 AM
Study NCT ID:
NCT04820166
Status:
RECRUITING
Last Update Posted:
2021-03-29
First Post:
2021-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Monitoring PVP on Clinical Outcomes in Patients With PH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2021-03-26', 'lastUpdatePostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastroesophageal varices bleeding', 'timeFrame': 'three years', 'description': 'Patients with gastroesophageal varices has hematemesis or melena, and active bleeding or red sign can be seen under endoscopy'}, {'measure': 'Ascites', 'timeFrame': 'three years', 'description': 'Peritoneal effusion was seen under ultrasound'}, {'measure': 'Hepatic encephalopathy', 'timeFrame': 'three years', 'description': 'Patients with altered consciousness or unresponsiveness, accompanied by elevated blood ammonia'}], 'secondaryOutcomes': [{'measure': 'Death or final follow-up time (3 years)', 'timeFrame': 'three years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Portal Hypertension']}, 'referencesModule': {'references': [{'pmid': '41178521', 'type': 'DERIVED', 'citation': 'Liu M, Zhang X, Cheng X, He Q, Zhou T, Wang H, Li B, Luo W, Li J, Li H, Lin Z, Song J, Wang W, Huang J, Ji Y, Zhou D, Xie W, Yang Q, Tu M, Luo X, Zhang X, Yan H, Chen J. Indocyanine Green Clearance Test via Pulse Dye Densitometry for Portal Hypertension Diagnosis in cACLD. Liver Int. 2025 Dec;45(12):e70425. doi: 10.1111/liv.70425.'}, {'pmid': '40105356', 'type': 'DERIVED', 'citation': 'Zhang X, Zhou L, Liang W, Cheng X, He Q, Li H, Luo W, Huang J, Li J, Wang W, Tu M, Wang H, Ou P, Wen B, Xiao L, Zhou D, Wong VW, Chen J. Identification of Clinically Significant Portal Hypertension in cACLD Individuals With Spleen Stiffness Measurement. Liver Int. 2025 Apr;45(4):e16241. doi: 10.1111/liv.16241.'}]}, 'descriptionModule': {'briefSummary': 'The complications associated with portal hypertension in cirrhosis are the main cause of death in patients with cirrhosis. The level of portal venous pressure is closely related to the prognosis of patients. HVPG (hepatic venous pressure gradient) is the "gold standard" for predicting portal venous pressure and an important indicator for evaluating the efficacy of NSBBS. However, monitoring HVPG has many limitations，and the clinical application is also limited to a certain extent. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. At the same time, to explore the correlation between HVPG and PPG in cirrhosis patients at different stages and different etiologies, and to evaluate the role of spleen stiffness in predicting the severity of esophageal and gastric varices in patients with portal hypertension, and to find biomarkers to predict the risk of complications related to portal hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with portal hypertension', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With chronic liver disease\n* Age 18-80 years\n* Patients who require a portal pressure measurement at the discretion of the treating physician\n* Voluntarily signed informed consent\n\nExclusion Criteria:\n\n* With serious cardiopulmonary disease or other diseases affect survival\n* With severe renal dysfunction\n* Concomitant portal vein cavernous degeneration or extensive portal vein thrombosis\n* Women who are planning to become pregnant or who are pregnant or breastfeeding\n* The researcher judged that it was not suitable to participate in this study'}, 'identificationModule': {'nctId': 'NCT04820166', 'briefTitle': 'The Effect of Monitoring PVP on Clinical Outcomes in Patients With PH', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'The Effect of Monitoring Portal Venous Pressure on Clinical Outcomes in Patients With Portal Hypertension: a Prospective, Single-center, Observational Study', 'orgStudyIdInfo': {'id': 'NFEC-2021-062'}}, 'armsInterventionsModule': {'interventions': [{'name': 'monitoring portal pressure gradient or hepatic venous pressure gradient', 'type': 'OTHER', 'description': 'measuring portal pressure gradient or hepatic venous pressure gradient regularly'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaofeng Zhang', 'role': 'CONTACT', 'email': '1282614092@qq.com'}], 'facility': 'Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiaofeng Zhang', 'role': 'CONTACT', 'email': '1282614092@qq.com', 'phone': '+8618565552050'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}