Metabolic Remodeling in Fontan Patients

NCT03886935 | Completed

• 1 other identifier: 201810011837
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Assessment of metabolic alterations in adult Fontan patients with a dominant left ventricle with the help of serum examinations (Metabolomics). The aim is to find a tool for the completion of the (semi-)invasive monitoring of Fontan hemodynamics.

Conditions

Congenital Heart Disease; Metabolism Disorder

Outcome Measures

Primary Outcomes (4)

• Metabolism of lipids

  Measurement of the serum concentration of the extended metabolism of lipids using the technique of Metabolomics (AbsoluteIDQ p180 kit, Biocrates Life Sciences AG, Innsbruck, Austria)

  blood sampling at one single point of time (baseline/day 1) in the context of a planned patient presentation at the pediatric cardiology outpatient clinic (without assessment of changes)

• Metabolism of amino acids and related compounds

  Measurement of the serum concentration of the extended metabolism of lamino acids using the technique of Metabolomics (AbsoluteIDQ p180 kit, Biocrates Life Sciences AG, Innsbruck, Austria)

  blood sampling at one single point of time (baseline/day 1) in the context of a planned patient presentation at the pediatric cardiology outpatient clinic (without assessment of changes)

• Metabolism of carbohydrates

  Measurement of the serum concentration of the extended metabolism of carbohydrates using the technique of Metabolomics (AbsoluteIDQ p180 kit, Biocrates Life Sciences AG, Innsbruck, Austria)

  blood sampling at one single point of time (baseline/day 1) in the context of a planned patient presentation at the pediatric cardiology outpatient clinic (without assessment of changes)

• Metabolism of ketone bodies

  Measurement of the serum concentration of ketone bodies using the technique of Metabolomics (AbsoluteIDQ p180 kit, Biocrates Life Sciences AG, Innsbruck, Austria)

  blood sampling at one single point of time (baseline/day 1) in the context of a planned patient presentation at the pediatric cardiology outpatient clinic (without assessment of changes)

Study Arms (2)

Fontan patients

The serum of Fontan patients is compared to the serum of healthy biventricular controls (Metabolomics)

Diagnostic Test: Metabolomics

Healthy biventricular controls

The serum of Fontan patients is compared to the serum of healthy biventricular controls (Metabolomics)

Diagnostic Test: Metabolomics

Interventions

Metabolomics DIAGNOSTIC_TEST

Fontan patients; Healthy biventricular controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ≥ 18 years with a Fontan circulation with a dominant left ventricle. Controls: age- and sex-matched healthy biventricular controls ≥ 18 years

You may qualify if:

• Fontan circulation (right systemic ventricle), biventricular heart with heart failure resp.
• ≥ 18 years
• Written informed consent of patients
• hours fasting period before blood sample

You may not qualify if:

• Intake of medication directly affecting metabolic (e.g. metabolism of lipids (statine)) or hemodynamic state (e.g. beta-blockers, sildenafil) (other than angiotensin converting enzyme (ACE)-inhibitors and anticoagulation therapy)
• Cachectic disease
• Non-congestive hepatic or renal dysfunction
• (Inherited) metabolic disorders

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Biocrates Life Sciences AG, Innsbruck, Austria: collaborator
• Tiroler Wissenschaftsförderung: collaborator

Related Publications (2)

• Michel M, Salvador C, Wiedemair V, Adam MG, Laser KT, Dubowy KO, Entenmann A, Karall D, Geiger R, Zlamy M, Scholl-Burgi S. Method comparison of HPLC-ninhydrin-photometry and UHPLC-PITC-tandem mass spectrometry for serum amino acid analyses in patients with complex congenital heart disease and controls. Metabolomics. 2020 Dec 15;16(12):128. doi: 10.1007/s11306-020-01741-8.

  PMID: 33319318 DERIVED

• Michel M, Dubowy KO, Zlamy M, Karall D, Adam MG, Entenmann A, Keller MA, Koch J, Odri Komazec I, Geiger R, Salvador C, Niederwanger C, Muller U, Scholl-Burgi S, Laser KT. Targeted metabolomic analysis of serum phospholipid and acylcarnitine in the adult Fontan patient with a dominant left ventricle. Ther Adv Chronic Dis. 2020 Apr 27;11:2040622320916031. doi: 10.1177/2040622320916031. eCollection 2020.

  PMID: 32426103 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Metabolic Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases

Study Officials

• Daniela Karall, Prof.

  Medical University of Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 22, 2019
• Study Start: January 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: January 1, 2019
• Last Updated: February 24, 2021

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share