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NCT Number: NCT05563376

Fontan-Sprechstunde

After successful Fontan surgery, the risk of mortality in childhood is only low. Unfortunately, some of the patients suffer from Fontan-typical long-term complications in the long-term course, whereby protein loss neuropathy must be mentioned in particular, which is described in the literature with an incidence of 3-14% (1, 2) and still has a 5-year risk of death of 6-12% today (2, 3). Protein loss tereopathy leads to loss of protein in the intestine and subsequently to diarrhea and edema. Other problems concern the liver, which can develop cirrhosis due to chronic congestion (4-6). Cardiac can lead to heart failure and arrhythmias.

The registry study described in this protocol is intended to identify factors that influence the treatment outcome of patients in the Fontan circulation in the long term through systematic prospective documentation of the data from our standardized and guideline-oriented treatment.

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Key information

Conditions

Univentricular Heart Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

6 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

In particular, the following points will be scientifically analyzed:

  • The development of lymphatic drainage disorders (7-9)
  • The cellular changes of the immunological system and metabolome (10) In addition to the clinical routine, weight-adapted EDTA blood for the isolation of peripheral blood mononuclear cells (PBMCs) for the scientific investigation of immunological changes and serum for the analysis of the metabolome will be examined at three times (Figure 1: Times 2, 4, 7) as part of a routine blood sample (10).
  • The recording and treatment of psychological, social and developmental abnormalities with the help of standardized questionnaires.
  • The evaluation of special sonography examinations of the liver and kidney in the long-term course, as well as their treatment.
  • The assessment of the hemodynamic peculiarities and the classification with regard to Cardiac function in the long-term course of patients with Fontan circulation.
  • The assessment of various laboratory parameters as risk parameters for the development of complications.
  • The recording of cardiopulmonary performance in the long-term course and its ability to be influenced by education regarding sporting activity and the handing over of an individualized training plan.
  • The influence of physical activity on possible complications of Fontan circulation.
  • The influence of early psychological, nutritional, or social intervention in the event of abnormalities on later complications of Fontan circulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • congenital heart defect of the univentricular type that has led to Fontan circulation

Exclusion criteria

  • no exclusion criteria

Treatment and study plan

Univentricular Hearts

Diagnostic Test

Prevention when factors are recognized

Primary outcomes

  1. Reducing mortality and morbidity and improving quality of life in long-term care for Fontan patients

    Time frame: 50 Jahre

    • Fontan Tunnel Obstruction
    • Fontan-typical klin. Symp. defined in points 5.+6. o. Presence of edema, ascites, susceptibility to infections, reduced resilience, cyanosis, lack of size and weight development, diarrhea
    • Heart or heart valve insufficiency defined as end-diastolic volume/BSA (EDP corrected) above the norm, ventricle ejection fraction (EF) <50%, atrioventricular heart valve insufficiency (AVI) >grade 2, aortic valve insufficiency >grade 2
    • Pathological lymphatic vessel imaging defined as lymphatic vasodilation (LAE) type ≥ 3 according to Biko et al. (abnormal supraclavicular lymphatic vasodilation with infiltration of the mediastinum) (7). Presence of mesenteric lymphatic vascular congestion (8)
    • Hypoproteinaemia defined as serum albumin <3.4 mg/dl (4), total protein (TP) <50 g/l
    • protein-losing enteropathy (PLE) defined as (3, 4)
    • Failing Fontan defined as Operative Fontan Take-down, Listing for Heart Transplantation and/or Death

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle Schöffl, PD

CONTACT

[email protected]

09131 85 33750

Sven Dittrich, Prof.

CONTACT

[email protected]

09131 85 33750

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Prospektive Erfassung Von standardmäßig Erhobenen Daten im Rahmen Der Erlanger Fontan-Sprechstunde Zur Behandlung Und Überwachung Von PatientInnen Mit univentrikulärem Herzfehler im Sinne Einer Fontan-Zirkulation

Important dates

Study start
2020
Primary completion
2031
Study completion
2041
First posted
Oct 3, 2022
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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