Liver Disease, Myocardial Fibrosis and Collaterals in the Adult Fontan Patient a Metabolomics and Proteomics Approach

Launched by MEDICAL UNIVERSITY INNSBRUCK · Feb 17, 2021

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how certain health issues, like liver disease and heart problems, develop in adults who have a special type of heart circulation called Fontan circulation. The researchers want to find out what causes the thickening of heart tissue (myocardial fibrosis) and the formation of new blood vessels (collateral circulation) in patients with complex congenital heart defects. By studying these mechanisms, they hope to improve care for these patients.

To participate in this trial, individuals must be at least 18 years old and provide written consent. Participants will need to fast for eight hours before giving a blood sample. The study is open to patients with Fontan circulation and healthy controls with normal heart function. However, certain conditions like obesity, diabetes, and heart rhythm issues may exclude someone from joining. If eligible, participants can expect to undergo tests that help the researchers gather important information about their health and the effects of their unique heart condition. This study is currently recruiting, and all genders are welcome to apply.

Gender

ALL

Eligibility criteria

• 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