RecruitingNCT06145100

Prediction of Portal Hypertension in Patients With CVID (CVID-pHT)

Evaluation of Ultrasound Parameters and Liver and Spleen Stiffness for Prediction of Clinically Significant Portal Hypertension in Patients With Common Variable Immunodeficiency Syndrome


Sponsor

University Hospital Freiburg

Enrollment

250 participants

Start Date

Nov 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Patients with CVID will be offered to participate in this observational trial during the routine annual visit in the outpatient clinic at the Center of chronic Immunodeficiency (CCI) of the University Medical Center Freiburg, Germany. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Patients with CVID

Exclusion Criteria2

  • no written informed consent
  • 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)

Interventions

DIAGNOSTIC_TESTUltrasound 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.


Locations(1)

University Medical Center Freiburg, Department of Medicine II

Freiburg im Breisgau, Germany

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NCT06145100


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