[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567140":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":26,"responsibleParty":39,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":10,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Hospital Universitario Virgen Macarena","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"All patients attending the hepatology clinic or hospitalized with a diagnosis of liver cirrhosis",null,"All patients attending outpatient clinics or hospitalized with a diagnosis of viral etiology or alcohol-related liver cirrhosis will be evaluated for the indication of primary prophylaxis with NSBB according to Baveno VII guidelines.\n\nThe choice of NSBB type was mainly based on clinical parameters, regardless of the presence of an acute hemodynamic response. In patients who did not show signs of circulatory dysfunction or refractory ascites, carvedilol was preferred, as it has been shown to be more potent in decreasing portal pressure. Carvedilol was initiated at a dose of 6.25 mg\u002Fday and, if tolerated, was subsequently increased to a target dose of 12.5 mg\u002Fday. Higher doses of carvedilol were only used in cases of concomitant hypertension. For propranolol users, the dose was progressively increased until the heart rate decreased to approximately 55 beats per minute. In patients with significant ascites, a maximum dose of 80 mg\u002Fday of propranolol was administered.",[13],{"name":14,"affiliation":15,"role":16},"RAFAELR R ROMERO CASTRO, DOCTOR","SAS","STUDY_DIRECTOR",[18,23],{"name":19,"role":20,"phone":21,"phoneExt":10,"email":22},"LOURDES LGS GRANDE SANTAMARIA, DOCTOR","CONTACT","+34 695919735","lourdes.grande.sspa@juntadeandalucia.es",{"name":24,"role":20,"phone":25,"phoneExt":10,"email":10},"ENRIQUE E SILVA ALBARELLOS, RESIDENTE","+34 622012615",[27],{"facility":5,"status":10,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":10},"Seville","SEVILLA","41009","Spain","ES",{"type":34,"coordinates":35},"Point",[36,37],-5.97317,37.38283,{"lat":37,"lon":36},{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Lourdes Grande Santamaría","ESPECIALISTA DE APARATO DIGESTIVO","100567140","evaluation-of-the-efficacy-and-safety-of-portal-pressure-gradient-ppg-measurement-guided-by-endoscopic-ultrasound-eus-in-the-therapeutic-algorithm-of-patients-with-liver-cirrhosis-100567140",false,"NCT06664307","Evaluation of the Efficacy and Safety of Portal Pressure Gradient (PPG) Measurement Guided by Endoscopic Ultrasound (EUS) in the Therapeutic Algorithm of Patients with Liver Cirrhosis.","GPP-USE","Inclusion Criteria:\n\n* Patients diagnosed with advanced liver disease with an indication for primary prophylaxis with NSBBs\n\nExclusion Criteria:\n\n\\- Age \\\u003C 18 years. 2. Advanced stage hepatocellular carcinoma not eligible for curative treatment. 3. Pregnancy. 4. Esophageal stenosis. 5. INR \\> 1.5. 6. Platelets \\\u003C 50,000 µL. 7. Ascites. 8. Patients with any contraindication for performing an upper gastrointestinal endoscopy.\n\n9\\. Patients with contraindication to NSBB treatment. 10. Refusal to sign the informed consent form to participate in the study","ALL","18 Years","85 Years",{"count":54,"type":55},35,"ESTIMATED","OBSERVATIONAL","The development of Clinical significant PH (CSPH) is a major driver of complications. PPG is the strongest predictor of decompensation . The shortcomings of GPVH measurements and invasiveness has resulted in an area of unmet clinical need. Non-selective beta-blockers (NSBB) have demonstrated efficacy in reducing PH. However, this requires a second invasive procedure, and there is high interindividual variability in the hemodynamic response to NSBB. EUS-guided GPP measurement emerges as a more accurate, accessible and less invasive technique to potentially predict chronic hemodynamic response. The aim of this project is to assess the safety and efficacy of EUS-derived GPP measurement (EUS-GPP) in patients diagnosed with cirrhosis, to assess the acute hemodynamic response through EUS-derived GPP to intravenous propranolol administration in order to determine the patients who would benefit from NSBB treatment in primary prophylaxis to prevent decompensation using a strategy guided by EUS-GPP measurement.",[59,60],"Portal Pressure Gradient (PPG) Measurement Guided by Endoscopic Ultrasound (EUS)","Hepatic Cirrhosis",[62],"Portal pressure gradient (PPG), endoscopic ultrasound (EUS) ,.the acute hemodynamic response","NOT_YET_RECRUITING","2024-10-28",{"date":66,"type":67},"2024-10-29","ACTUAL",{"date":69,"type":55},"2024-11-01",{"date":71,"type":55},"2027-11-01",{"name":5,"class":6},1]