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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with CVID

Locations
Other Locations
Germany
University Medical Center Freiburg, Department of Medicine II
RECRUITING
Freiburg Im Breisgau
Contact Information
Primary
Dominik Bettinger, MD
dominik.bettinger@uniklinik-freiburg.de
+49761270-36870
Backup
Marlene Reincke, MD
marlene.reincke@uniklinik-freiburg.de
+49761270-34010
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 250
Treatments
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)
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
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).
Sponsors
Leads: University Hospital Freiburg

This content was sourced from clinicaltrials.gov

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