Actively Recruiting

Phase Not Applicable
Age: 6Years - 60Years
All Genders
NCT05563376

Fontan-Sprechstunde

Led by University of Erlangen-Nürnberg Medical School · Updated on 2022-10-03

200

Participants Needed

1

Research Sites

1095 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Fontan-Sprechstunde

Who Can Participate

Age: 6Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a congenital heart defect of the univentricular type that has resulted in Fontan circulation
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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1
2
3
+1

Trial Site Locations

Total: 1 location

1

Universitätsklinikum

Erlangen, Germany, 91054

Actively Recruiting

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Research Team

I

Isabelle Schöffl, PD

CONTACT

S

Sven Dittrich, Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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Fontan-Sprechstunde | DecenTrialz