Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD

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.

NCT Number	NCT07535203
Lead Sponsor	Sisca Natalia Siagian Collaborators: LMU Klinikum, Fakultas Kedokteran Universitas Indonesia, National Cardiovascular Center Harapan Kita Hospital Indonesia
Conditions	Congenital Heart Disease (CHD), Univentricular Heart
Enrollment	52 participants
Start Date	2025-01-01
Primary Completion	2027-03-01 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-04-17