Prediction of Portal Hypertension in Patients With CVID (CVID-pHT)
NCT ID: NCT06145100
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2023-11-01
2025-12-31
Brief Summary
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Clinical and laboratory data at the time of presentation will be assessed. Additionally, parameters of abdominal ultrasound, duplex sonography of the liver and spleen, and liver and spleen stiffness at the time of presentation will be evaluated. If applicable, clinical and/or interventional parameters indicating clinically significant portal hypertension (i.e. presence of varices or portal-hypertensive gastropathy in esophago-gastroduodenoscopy, presence of ascites) within 12 months prior and after the index visit will be assessed. During the visit, serum/plasma samples and peripheral blood mononuclear cells (PBMC) are collected and stored in an associated biobank.
Detailed Description
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Patients will be recruited during the routine annual visit in the outpatient clinic at the Center of chronic Immunodeficiency (CCI) of the University Medical Center Freiburg, Germany. During the visit a standard ultrasound protocol, including size and morphology of liver and spleen, duplex-sonography of the liver, and measurement of liver and spleen stiffness via transient elastography will be performed as a part of the routine clinical diagnostic. Results from endoscopy or other interventions (esophago-gastroduodenoscopy, invasive measurement of hepatic venous-portal pressure gradient, or TIPS implantation, if applicable) within 12 months prior and after the index visit will be assessed. All non-invasive and invasive interventions will be conducted solely based on clinical decisions made independently from the study inclusion as the study is designed as an observational study.
Detailed patient characteristics, epidemiologic, clinical, imaging and laboratory parameters will be assessed and included in an electronic database.
Apart from these data, patients will be asked to participate in biobank sampling including serum/plasma and peripheral blood mononuclear cells (PBMC) samples from the peripheral veins.
All patients recruited in this study will be followed-up for at least 12 months.
Outcome parameters include parameters from abdominal ultrasound, duplex-sonography and stiffness of liver and spleen, presence or development of clinically significant portal hypertension and non-invasive fibrosis scores based on laboratory and ultrasound parameters.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with CVID and autoimmunity and no liver involvement.
Patients with CVID and autoimmune disease, but no liver involvement (normal liver enzymes and normal abdominal ultrasound)
Ultrasound including color doppler ultrasound
Patients with CVID receive color doppler ultrasound of the liver including assessment of portal vein diameter, portal vein flow velocity, hepatic vein diameter and assessment of arterial perfusion. Further liver and spleen stiffness measurement by transient elastography is performed.
Patients with CVID and liver involvement and no clinical significant portal hypertension
Patients with CVID and liver involvement (elevated liver enzymes, abnormal ultrasound and/or abnormal liver biopsy), but no clinically significant portal hypertension
Ultrasound including color doppler ultrasound
Patients with CVID receive color doppler ultrasound of the liver including assessment of portal vein diameter, portal vein flow velocity, hepatic vein diameter and assessment of arterial perfusion. Further liver and spleen stiffness measurement by transient elastography is performed.
Patients with CVID and clinically significant non-cirrhotic portal hypertension
Patients with CVID and clinically significant non-cirrhotic portal hypertension (indicated by the presence of ascites or esophageal varices / portal-hypertensive gastropathy).
Ultrasound including color doppler ultrasound
Patients with CVID receive color doppler ultrasound of the liver including assessment of portal vein diameter, portal vein flow velocity, hepatic vein diameter and assessment of arterial perfusion. Further liver and spleen stiffness measurement by transient elastography is performed.
Interventions
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Ultrasound including color doppler ultrasound
Patients with CVID receive color doppler ultrasound of the liver including assessment of portal vein diameter, portal vein flow velocity, hepatic vein diameter and assessment of arterial perfusion. Further liver and spleen stiffness measurement by transient elastography is performed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* concomitant chronic liver disease (viral hepatitis, alcoholic liver disease, steatitic liver disease, hemochromatosis, primary biliary cholangitis, primary sclerosis cholangitis, M. Wilson, alpha-1-antitrypsin deficiency)
18 Years
ALL
No
Sponsors
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University Hospital Freiburg
OTHER
Responsible Party
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Prof. Dr. Dominik Bettinger
Principal Investigator
Principal Investigators
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Dominik Bettinger, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Freiburg
Klaus Warnatz, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Freiburg
Marlene Reincke, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Freiburg
Locations
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University Medical Center Freiburg, Department of Medicine II
Freiburg im Breisgau, , Germany
Countries
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Central Contacts
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Facility Contacts
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Dominik Bettinger, MD
Role: primary
Marlene Reincke, MD
Role: backup
Other Identifiers
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CVID-pHT
Identifier Type: -
Identifier Source: org_study_id