Metabolic Remodeling in Fontan Patients

Congenital Heart Disease Clinical Trial

Official title:

Metabolic Remodeling in Fontan Patients: a Metabolomics Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03886935
• Other study ID #: 201810011837
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: January 2017
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Patients who are born with just one single heart chamber need to undergo surgical therapy allowing the single heart chamber to pump the blood into the systemic circulation and allowing the blood to flow passively to the lungs (Fontan circulation). Regular ultrasound, cardiopulmonary exercise testing, and invasive diagnostic tools (catheterization, general anaesthesia needed) are necessary to early find out cardiac, vascular, or circulatory impairment. It is still very difficult to diagnose and therapy failure of this Fontan system early enough.

It is reported that in patients with a failing two-chambered heart, the energy source for the heart and the body in general switches from the use of lipids to the use of sugar and ketone bodies. First studies show decreased concentrations of membrane lipids in Fontan patients with a left dominant ventricle, and the energy metabolism has not been focused yet in those patients.

The investigators hypothesize that there are differences in the pattern of the structural metabolism in adult Fontan patients with a left-dominant vs. a right-dominant ventricle. Furthermore the investigators hypothesize that there are alterations in the energy metabolism in adult Fontan patients in comparison to healthy two-chambered controls, and that those alterations correlate with the grade of impairment of cardiopulmonary function.

With the help of a special biochemical examination (mass spectrometry-based Metabolomics study) blood of Fontan patients will be analyzed, and the results will be correlated with the results of ultrasound and cardiopulmonary exercise testing. The aim of this study is to establish sensitive blood markers indicating cardiac, vascular, circulatory or further organ dysfunction in Fontan patients. This should allow optimal Fontan system monitoring with an optimal timing of an additional invasive diagnostic catheterization and of nutritional, medical or interventional therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Fontan circulation (right systemic ventricle), biventricular heart with heart failure resp.

• = 18 years

• Written informed consent of patients

• 8 hours fasting period before blood sample

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Diseases
• Metabolic Diseases
• Metabolism Disorder

Intervention

Diagnostic Test:
• Metabolomics

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Medical University Innsbruck	Biocrates Life Sciences AG, Innsbruck, Austria, Tiroler Wissenschaftsförderung

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)