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

Non-Cirrhotic Portal Hypertension Common Variable Immunodeficiency

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

Plain Language Summary

Simplified for easier understanding

This study aims to identify which patients with Common Variable Immunodeficiency (CVID) — a condition where the immune system does not make enough antibodies — are at risk of developing high blood pressure in the liver's portal vein, a serious complication. **You may be eligible if...** - You have been diagnosed with CVID (a type of immune deficiency) **You may NOT be eligible if...** - You are unable or unwilling to sign an informed consent form - You have another known chronic liver disease, such as viral hepatitis, alcoholic liver disease, fatty liver disease, hemochromatosis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, or alpha-1 antitrypsin deficiency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.