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

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ClinicalTrials.gov Identifier: NCT04764305
Recruitment Status : Not yet recruiting
First Posted : February 21, 2021
Last Update Posted : August 31, 2021
Sponsor:
Collaborators:
Heart and Diabetes Center North Rhine-Westphalia
Austrian Science Fund (FWF)
Information provided by (Responsible Party):
OÄ Dr. Miriam Michel, Medical University Innsbruck

Study Description
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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.

Condition or disease
Patient Participation Heart Defects, Congenital Liver Diseases Collateral Circulation, Any Site Myocardial Fibrosis

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 circulation. Those patients are also prone to develop hepatic and myocardial fibrosis as well as to reveal collateral vessel formation. The investigators' hypothesis is that this pro-inflammatory condition is not only reflecting pre-stages of one or more of those 3 issues, but that this is also a main driving mechanism to develop and hepatic or myocardial fibrosis and collateral vessels.

The objective of the here proposed study thus is to identify the mechanisms that promote hepatic and myocardial fibrosis, and collateral vessel formation, and thus provide insight into the determination of those Fontan patients that tend to develop those conditions. The investigators attempt to link the issues of hepatic and myocardial fibrosis and collateral vessel formation by directing our focus on the phospholipid, amino acid and bile acid metabolism and on cell surface markers, cytokines, and chemokines as surrogates for proinflammatory, profibrotic and proangiogenic conditions.

This study would thereby allow for a deeper insight into Fontan pathophysiology and sequelae and might provide first steps towards the identification of possible diagnostic or eventually therapeutic targets.

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Liver Disease, Myocardial Fibrosis and Collaterals in the Adult Fontan Patient - a Metabolomics and Proteomics Approach
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Groups and Cohorts
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Group/Cohort
Patients
Patients with Fontan circulation. No intervention planned (observational study)
Controls
Healthy, biventricular controls. No intervention planned (observational study)


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants [ Time Frame: July 2021-December 2023 ]
    When aspired number of participants is reached


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with Fontan circulation, see inclusion criteria. Healthy, biventrucal age- and sex-matched controls.
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: OÄ Dr. Miriam Michel, Principal Investigator, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT04764305    
Other Study ID Numbers: registration in progress
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by OÄ Dr. Miriam Michel, Medical University Innsbruck:
Fontan
congenital heart disease
inflammation
 Fontan-associated liver disease
Myocardial fibrosis
Collateral vessel
Additional relevant MeSH terms:
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Liver Diseases
Heart Defects, Congenital
Cardiomyopathies
Congenital Abnormalities
Fibrosis
 Pathologic Processes
Digestive System Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases