Gut, Inflammation and Nutrition in Adult Patients After Fontan Operation

NCT06731322 | Completed

• 1 other identifier: 20240021
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This observational case-control study aims to investigate intestinal barrier dysfunction, systemic inflammation, and nutritional status in adult patients after Fontan operation. Fontan operation, a palliative intervention for complex congenital heart defects, leads to an elevated systemic venous pressure, contributing to systemic complications, including gastrointestinal disturbances and liver disease. While protein-losing enteropathy (PLE) is a known complication, this study focuses on patients without PLE to assess less-studied effects on the gastrointestinal system. The elevated systemic venous pressure in adult patients after Fontan operation may impair the protective and absorptive functions of the gastrointestinal tract. This dysfunction allows bacterial endotoxins to enter the bloodstream, triggering systemic inflammation, which can worsen heart failure, cause malnutrition, and lead to cachexia. Although these outcomes are established in acquired heart failure, there is a lack of studies specifically examining the gastrointestinal consequences in adult patients after Fontan operation without PLE. In this study, adult Fontan patients without PLE will be compared to a control group of healthy adults or adult patients with simple congenital heart defects and normal systemic venous pressure. The study will evaluate intestinal barrier dysfunction, systemic inflammatory responses, and malnutrition through several methods: serum biomarkers (I-FABP, LBP, TNF-α, IL-6, etc.), nutritional assessment including body composition assessment using bioelectrical impedance analysis and measurements of serum microelements, echocardiography, and abdominal ultrasound with liver elastography. The findings of the study will help elucidate the connection between intestinal barrier dysfunction, inflammation, and nutritional status in adult patients after Fontan operation, aiming to improve long-term outcomes for this unique patient population.

Conditions

Fontan Circulation; Fontan Procedure

Keywords

Fontan procedure, gut, inflammation, nutrition

Outcome Measures

Primary Outcomes (3)

• Serum biomarkers of intestinal barrier dysfunction

  Patients after Fontan operation will have higher serum biomarkers of intestinal barrier dysfunction in comparison to the control group

  Baseline

• Serum biomarkers of systemic inflammation

  Patients after Fontan operation will have higher serum biomarkers of systemic inflammatory response in comparison to the control group

  Baseline

• Assessment of nutritional disorders

  Patients after Fontan operation will have more nutritional disorders in comparison to the control group

  Baseline

Study Arms (2)

Fontan operation group

Adults (\>18 years old) after Fontan operation and without active protein-losing enteropathy

Control group

Control group is comprised of either: 1. Healthy adults (\>18 years old) without known chronic disease and without regular medications 2. Adults (\>18 years old) with simple congenital heart defects without significant residual lesions or comorbidities

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

We will invite adult patients who have undergone Fontan surgery and are followed up in the Adult Congenital Heart Disease Clinic at the Clinical Department of Cardiology, University Medical Centre Ljubljana. Patients with a known protein-losing enteropathy following Fontan surgery will be excluded. The control group will consist of healthy adults without known chronic disease or regular medications or adult patients after surgical or percutaneous repair of simple congenital heart defects (atrial or ventricular septal defects). Control patients will be without clinical signs of heart failure and with normal systemic venous pressure as assessed by ultrasound.

You may qualify if:

• Adult patients (\>18 years old) after Fontan operation

You may not qualify if:

• Active protein losing enteropathy
• Disability preventing informed consent

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University medical centre Ljubljana (UKC Ljubljana)

Ljubljana, 1000, Slovenia

Location

Related Publications (5)

• Go K, Horiba K, Yamamoto H, Morimoto Y, Fukasawa Y, Ohashi N, Yasuda K, Ishikawa Y, Kuraishi K, Suzuki K, Ito Y, Takahashi Y, Kato T. Dysbiosis of gut microbiota in patients with protein-losing enteropathy after the Fontan procedure. Int J Cardiol. 2024 Feb 1;396:131554. doi: 10.1016/j.ijcard.2023.131554. Epub 2023 Oct 22.

  PMID: 37875211 BACKGROUND

• Saraf A, De Staercke C, Everitt I, Haouzi A, Ko YA, Jennings S, Kim JH, Rodriguez FH, Kalogeropoulos AP, Quyyumi A, Book W. Biomarker profile in stable Fontan patients. Int J Cardiol. 2020 Apr 15;305:56-62. doi: 10.1016/j.ijcard.2020.01.012. Epub 2020 Jan 9.

  PMID: 31959411 BACKGROUND

• Sharma R, Bolger AP, Li W, Davlouros PA, Volk HD, Poole-Wilson PA, Coats AJ, Gatzoulis MA, Anker SD. Elevated circulating levels of inflammatory cytokines and bacterial endotoxin in adults with congenital heart disease. Am J Cardiol. 2003 Jul 15;92(2):188-93. doi: 10.1016/s0002-9149(03)00536-8.

  PMID: 12860222 BACKGROUND

• Rychik J, Atz AM, Celermajer DS, Deal BJ, Gatzoulis MA, Gewillig MH, Hsia TY, Hsu DT, Kovacs AH, McCrindle BW, Newburger JW, Pike NA, Rodefeld M, Rosenthal DN, Schumacher KR, Marino BS, Stout K, Veldtman G, Younoszai AK, d'Udekem Y; American Heart Association Council on Cardiovascular Disease in the Young and Council on Cardiovascular and Stroke Nursing. Evaluation and Management of the Child and Adult With Fontan Circulation: A Scientific Statement From the American Heart Association. Circulation. 2019 Aug 6;140(6):e234-e284. doi: 10.1161/CIR.0000000000000696. Epub 2019 Jul 1.

  PMID: 31256636 BACKGROUND

• Valentova M, von Haehling S, Bauditz J, Doehner W, Ebner N, Bekfani T, Elsner S, Sliziuk V, Scherbakov N, Murin J, Anker SD, Sandek A. Intestinal congestion and right ventricular dysfunction: a link with appetite loss, inflammation, and cachexia in chronic heart failure. Eur Heart J. 2016 Jun 1;37(21):1684-91. doi: 10.1093/eurheartj/ehw008. Epub 2016 Feb 9.

  PMID: 26865478 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood sample for additional serum biomarker assesment

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nejc Pavšič, MD, PhD

  UMC Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 12, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

SL (1)