Actively Recruiting
Comparison of Outcomes of Pulmonary Oligemia Versus Pulmonary Plethora in Cyanotic Congenital Heart Disease With Univentricular Heart After Fontan Procedure
Led by Sisca Natalia Siagian · Updated on 2026-04-17
52
Participants Needed
1
Research Sites
13 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 research aims to compare clinical outcomes in patients with cyanotic congenital heart disease (CHD) and univentricular heart physiology who undergo staged surgical palliation culminating in the Fontan procedure. It focuses on differences between those with pulmonary oligemia, meaning reduced pulmonary blood flow, and pulmonary plethora, meaning increased pulmonary blood flow. The study seeks to understand how these pulmonary blood flow conditions affect survival, lung development, and overall health after the Fontan procedure. Participants will receive standard clinical care involving staged surgeries including the Bidirectional Glenn and Fontan procedures. They will be grouped based on their pulmonary blood flow type—either oligemia or plethora—and followed for about 1.5 years after the Fontan procedure. Assessments will include clinical exams, laboratory tests, imaging, and hemodynamic studies, with no experimental treatments administered. Throughout the study, researchers will monitor mortality and morbidity, pulmonary artery pressures and resistance, exercise capacity through a six-minute walk test, neurocognitive function using standardized tests, and quality of life questionnaires. Biomarker levels and lung tissue samples will also be analyzed during surgeries. Follow-up evaluations will occur up to 12 months post-Fontan to gather comprehensive data for improving care in this patient group.
CONDITIONS
Brief 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 available
- Inability to complete follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable timing according to clinical schedule
Participants undergo standard staged surgical palliation including Bidirectional Glenn and Fontan procedures as part of routine clinical care. Tissue and blood samples are collected during these procedures for analysis.
2 visits corresponding to Bidirectional Glenn and Fontan procedures
Duration - Approximately 18 months
Participants are followed for approximately 1.5 years post-Fontan procedure to monitor mortality, morbidity, exercise capacity, neurocognitive outcomes, quality of life, and pulmonary hemodynamics.
Multiple visits including assessments at about 3 and 6 months post-Fontan and periodic clinical evaluations during follow-up
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
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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