I50.9
Conditions
Interventions
Group 1: 20 patients each with Fontan circulation or atrial switch operation for d-TGA who are clinically stable but have experienced a worsening of the clinical situation within the last 6 months
Sponsors
Deutsches Herzzentrum München, Klinik für angeborene Herzfehler und Kinderkardiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with Fontan circulation or atrial switch operation for d-TGA who are clinically stable but have experienced a worsening of their clinical condit ion within the last 6 months, necessitating an expansion of anti-congestive therapy from a clinical perspective. They should be in functional class 2 or 3 and, preferably, have shown an elevated end-diastolic pressure in the systemic ventricle during a cardiac catheterization within the last 24 months and/or a shift to a higher functional class
Exclusion criteria
Exclusion criteria: Excluded are patients in functional class 4 and patients with relevant pulmonary vascular pathology (transpulmonary gradient in Fontan patients = 4 mm Hg). Also excluded are all patients whose concomitant medication cannot be kept constant during the 6-week observation period. Additionally, patients with type I diabetes mellitus, patients under 18 years of age, as well as patients with atrial fibrillation and end-stage renal failure (eGFR < 30 ml/min/1.73 m²) will not be included
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| increase in cardiac output | — |
Secondary
| Measure | Time frame |
|---|---|
| increase of enddiastolic volume of systemic ventricle, ejection fraction of the systemic ventricle, serum NT-pro BNP | — |
Countries
Germany
Contacts
Public ContactHeiko Stern
Deutsches Herzzentrum München, Klinik für angeborene Herzfehler und Kinderkardiologie
Outcome results
None listed