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

NCT04764305 | Recruiting DMC

• 1 other identifier: registration in progress
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Participation; Heart Defects, Congenital; Liver Diseases; Collateral Circulation, Any Site; Myocardial Fibrosis

Keywords

Fontan; congenital heart disease; inflammation; Fontan-associated liver disease; Myocardial fibrosis; Collateral vessel

Outcome Measures

Primary Outcomes (1)

• Number of participants

  When aspired number of participants is reached

  July 2021-December 2023

Study Arms (2)

Patients

Patients with Fontan circulation. No intervention planned (observational study)

Controls

Healthy, biventricular controls. No intervention planned (observational study)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with Fontan circulation, see inclusion criteria. Healthy, biventrucal age- and sex-matched controls.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Heart and Diabetes Center North Rhine-Westphalia: collaborator
• Austrian Science Fund (FWF): collaborator

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Austria

RECRUITING

MeSH Terms

Conditions

Patient Participation; Heart Defects, Congenital; Liver Diseases; Inflammation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Miriam Michel, MD

  Medical University of Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria-Miriam Michel, MD

CONTACT

+436606862227; miriam.michel@i-med.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: April 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)