Investigating liver and heart issues in Fontan patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the mechanisms behind liver and heart fibrosis, as well as collateral vessel formation in adults with Fontan circulation. The researchers will focus on the metabolic processes involving phospholipids, amino acids, and bile acids, alongside inflammatory markers to understand the underlying pro-inflammatory conditions. By linking these factors, the study seeks to provide insights into the pathophysiology of Fontan patients and identify potential diagnostic or therapeutic targets for those at risk of developing these complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* written informed consent of participants
* age at testing of ≥18 years
* 8 h fasting before blood sampling
* Fontan circulation (patients)
* biventricular heart without structural or functional abnormality (controls)

Exclusion Criteria:

* Protein losing enteropathy (PLE) (patients are defined as "PLE positive" if there is/are serum protein \<5g/dL and serum albumin \<3g/dL (duration for more than 3 months and exclusion of other causes for hypoproteinemia) and documented enteric protein loss: faecal alpha-1-antitrypsin ≥400 µg/g
* medication directly affecting metabolic state, such as cholesterol-lowering agents, or haemodynamic state, such as beta-blockers or sildenafil, with the exception of angiotensin converting enzyme inhibitors, diuretics, and anticoagulants
* atrial or ventricular arrhythmia
* coronary artery disease (history of myocardial infarction, myocardial revascularisation, percutaneous coronary intervention, or coronary artery bypass surgery)
* any metabolic disease, such as diabetes mellitus
* malignancy
* obesity (body mass index (BMI) \>25 kg/m2)
* underweight (BMI \< 18 kg/m2)
* renal disease
* inflammatory disease such as acute or chronic infection
* myeloproliferative disorder
* pregnancy or lactation
* malnourishment
* mental handicap not allowing valid consent to participation in the study or CMR
* need of sedation or general anesthesia for CMR
* typical contraindications for performing CMR such as metal-containing mechanical or electronic implants
* claustrophobia

Where it's running

• Medical University of Innsbruck
  Innsbruck, Austria Recruiting

Study contacts

• Principal investigator: Miriam Michel, MD — Medical University of Innsbruck
• Study coordinator: Maria-Miriam Michel, MD
• Email: miriam.michel@i-med.ac.at
• Phone: +436606862227

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.