Status:
RECRUITING
Liver Disease, Myocardial Fibrosis and Collaterals in the Adult Fontan Patient a Metabolomics and Proteomics Approach
Lead Sponsor:
Medical University Innsbruck
Collaborating Sponsors:
Heart and Diabetes Center North Rhine-Westphalia
Austrian Science Fund (FWF)
Conditions:
Patient Participation
Heart Defects, Congenital
Eligibility:
All Genders
18+ years
Brief Summary
Out objective is to identify the mechanisms that promote hepatic and myocardial fibrosis, and collateral vessel formation in patients with complex congenital heart disease and Fontan circulation.
Detailed Description
In their prior works the investigators could show that there is evidence of a proinflammatory condition in a certain subgroup of patients with complex congenital heart disease and a so called Fontan c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04764305
Start Date
April 1 2022
End Date
December 31 2025
Last Update
March 13 2024
Active Locations (1)
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1
Medical University of Innsbruck
Innsbruck, Austria