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Not yet recruiting NCT07314814

Genetic Hallmarks of Patients With Congenital Portosystemic Shunts and Portopulmonary Hypertension

Observational Portopulmonary Hypertension Pulmonary Arterial Hypertension (PAH) Congenital Portosystemic Shunt

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: targeted gene panels analysis, whole genome analysis.
Who it may be relevant to
Registry conditions: Portopulmonary Hypertension, Pulmonary Arterial Hypertension (PAH), Congenital Portosystemic Shunt. Basic parameters: 1 Day — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Congenital portosystemic shunt (CPSS) are rare vascular malformations causing blood from the intestines to bypass the liver and directly flow into body's general circulation. Such liver bypass can cause several health problems, one of the most severe being portopulmonary hypertension (PoPH). The goal of this study is to identify pathogenic and potentially pathogenic genetic variants in patients who have both CPSS and PoPH. Future research will assess the contribution of these genetic variants to the development of PoPH. The long-term goal is to use genetic information to identify patients with congenital portosystemic shunts (CPSS) or chronic liver disease who are at risk of developing PoPH to offer anticipatory management. Children and adult patients with both CPSS and PoPH, as well as their close relatives (patient's parents and siblings) can take part in the study. Genetic variations within each family will be studied.

Interventions

  • Genetic targeted gene panels analysis
    The following gene panels will be analyzed : pulmonary arterial hypertension ; hereditary hemorrhagic telangiectasia ; congenital heart disease and potentially pathogenic variants in genes previously associated with PoPH in cirrhosis cohort.
  • Genetic whole genome analysis
    Family-based identification of dominant or recessive potentially pathogenic variants.

Primary outcome measures

  • List of variants from targeted analysis of selected gene panels [Time frame: From February 2026 to February 2029]
  • List of variants from whole genome analysis [Time frame: Fron February 2026 to August 2029]

Eligibility criteria

Inclusion criteria

  • Patient is a participant to the IRCPSS with history of PoPH
  • Trios composed of CPSS PoPH patients and their parents (trios are mandatory)
  • Brother/sister of an enrolled patient
  • Trios accept to provide biological samples (blood), sign the inform consent.
  • Siblings and/or siblings' legal representatives accept to provide biological samples (blood), sign the inform consent.

Exclusion criteria

  • Trio condition is not met.
  • No genuine parent-offspring trios (check for medically assisted procreation with donors, and adoption)
  • For siblings, half-brothers or half-sisters are excluded, as well as adopted children, or children issued from medically assisted procreation with donors.
  • Secondary portosystemic shunts
  • The refusal by the patient or the patient's legal representatives to provide biological samples or agree with the proposed procedure or after voluntary withdrawal from the project.
  • The refusal of one of the parents to provide biological samples or to agree with the proposed procedure or after voluntary withdrawal from the project.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Family-based

Study locations

Switzerland · 1 center
  • University Hospitals Geneva / University of Geneva — Geneva

Identifiers

NCT: NCT07314814 · 2024-01698 · 2024-01698

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗