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NCT06731322: GIN-Fontan
Gut, Inflammation and Nutrition in Adult Patients After Fontan Operation
trial in Fontan Circulation in 52 participants. Completed in 1 October 2025.
1 October 2025
Quick facts
| Lead sponsor | University Medical Centre Ljubljana |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 52 |
| Start date | 1 October 2024 |
| Primary completion | 1 October 2025 |
| Estimated completion | 1 October 2025 |
| Sites | 1 location across Slovenia |
Conditions studied
- Fontan Circulation — all drugs for Fontan Circulation →
- Fontan Procedure — all drugs for Fontan Procedure →
Sponsor
University Medical Centre Ljubljana
Who can join
18 and older, any sex, with Fontan Circulation or Fontan Procedure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06731322
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Fontan Circulation
Currently open trials in the same condition.
- NCT06324396 — IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease · Phase 1 · recruiting
- NCT06258382 — Fontan Circulation and Reproductive Health in a National Swedish Cohort · recruiting
Other University Medical Centre Ljubljana trials
Trials by the same sponsor.
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- NCT07446244 — Catheter Ablation of Advanced Forms of Atrial Fibrillation · NA · enrolling by invitation
- NCT07109076 — Effect of Immediate Skin-to-Skin Contact on Neonatal Heart Rate Variability After Cesarean Secton · NA · recruiting
- NCT07354880 — Effect of Tirzepatide on Cardiovascular and Metabolic Parameters in Obese Adult Patients With Congenital Heart Disease · Phase 4 · not yet recruiting
- NCT07496736 — Post-exposure Influenza Prophylaxis in a Hospital Setting · Phase 3 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06731322 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Medical Centre Ljubljana
- Last refreshed: 18 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06731322.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing