Fontan-Sprechstunde
ConditionUniventricular Heart
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-60
SponsorUniversity of Erlangen-Nürnberg Medical School
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
congenital heart defect of the univentricular type that has led to Fontan circulation
Disqualifiers
no exclusion criteria
Trial design
Design model
Single group
Treatments tested in this trial
Univentricular Hearts
Diagnostic testPrevention when factors are recognized
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: TCPC completedOther 1 intervention
Trial outcomes
Primary outcomes
1
Reducing mortality and morbidity and improving quality of life in long-term care for Fontan patients
1. Fontan Tunnel Obstruction 2. 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 3. 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 4. 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) 5. Hypoproteinaemia defined as serum albumin \<3.4 mg/dl (4), total protein (TP) \<50 g/l 6. protein-losing enteropathy (PLE) defined as (3, 4) 7. Failing Fontan defined as Operative Fontan Take-down, Listing for Heart Transplantation and/or Death
Time frame
50 JahreSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov