About this trial
This prospective cohort study evaluates differences in clinical outcomes between pulmonary oligemia and pulmonary plethora in patients with cyanotic congenital heart disease and univentricular heart physiology undergoing staged palliation culminating in the Fontan procedure.Fifty-two patients will be classified into two groups based on pulmonary blood flow characteristics and followed for approximately 1.5 years after the Fontan procedure. Outcomes include mortality, morbidity, pulmonary hemodynamics, functional capacity, neurocognitive status, and quality of life.
Eligibility criteria
Qualifiers
Diagnosed cyanotic CHD
Univentricular heart physiology
Planned staged palliation including Fontan procedure
Informed consent obtained (patient or guardian)
Disqualifiers
Refusal to participate
Incomplete clinical data
Inability to complete follow-up
Trial design
Treatments tested in this trial
- Fontan Procedure
Treatment groups
Sponsors and collaborators
Sisca Natalia Siagian
Lead sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor institution
LMU Klinikum
Collaborator
Fakultas Kedokteran Universitas Indonesia
Collaborator
National Cardiovascular Center Harapan Kita Hospital Indonesia
Collaborator