Actively Recruiting
Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD
Led by Sisca Natalia Siagian · Updated on 2026-04-17
52
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
S
Sisca Natalia Siagian
Lead Sponsor
L
LMU Klinikum
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed cyanotic congenital heart disease
- Univentricular heart physiology
- Planned staged palliation including Fontan procedure
- Informed consent obtained from patient or guardian
You will not qualify if you...
- Refusal to participate in the study
- Incomplete clinical data
- Inability to complete follow-up assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cardiovascular Center Harapan Kita
Jakarta, DKI Jakarta, Indonesia, 11420
Actively Recruiting
Research Team
S
Sisca Natalia Siagian, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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