Fontan outcomes with low versus high lung blood flow in single‑ventricle hearts
Comparison of Outcomes of Pulmonary Oligemia Versus Pulmonary Plethora in Cyanotic Congenital Heart Disease With Univentricular Heart After Fontan Procedure
This project will test whether people with single‑ventricle congenital heart disease who have reduced versus increased pulmonary blood flow do better or worse after the Fontan operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 52 (estimated) |
| Sex | All |
| Sponsor | National Cardiovascular Center Harapan Kita Hospital Indonesia Academic / other |
| Locations | 1 site (Jakarta, DKI Jakarta) |
| Trial ID | NCT07535203 on ClinicalTrials.gov |
What this trial studies
This is a prospective cohort of about 52 patients with univentricular heart physiology who will be classified as having pulmonary oligemia (reduced flow) or plethora (increased flow) and followed through staged palliation including the Glenn and Fontan procedures. Participants will receive standard clinical care while undergoing serial clinical, laboratory, imaging, and hemodynamic assessments, including biomarkers (NT‑proBNP, ET‑1, Activin‑A), exercise testing, neurocognitive testing, and quality‑of‑life measures. The primary outcomes include mortality and major morbidity, with secondary outcomes covering pulmonary hemodynamics, functional capacity, biomarkers, neurocognitive status, and quality of life. Follow‑up extends approximately 1.5 years after the Fontan operation to capture early post‑Fontan outcomes.
Who should consider this trial
Good fit: Ideal candidates are people with cyanotic congenital heart disease and univentricular heart physiology who are planned for staged palliation culminating in the Fontan operation and can provide consent and complete follow‑up.
Not a fit: Patients without univentricular physiology, those who refuse participation, have incomplete data, or cannot complete follow‑up are unlikely to benefit from the study's findings.
Why it matters
Potential benefit: If successful, the findings could help doctors better predict which patients are at higher risk after Fontan and tailor management to improve outcomes.
How similar studies have performed: Previous research links altered pulmonary blood flow to abnormal lung development and worse hemodynamics, but few prospective cohorts have directly compared Fontan outcomes by oligemia versus plethora, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed cyanotic CHD * Univentricular heart physiology * Planned staged palliation including Fontan procedure * Informed consent obtained (patient or guardian) Exclusion Criteria: * Refusal to participate * Incomplete clinical data * Inability to complete follow-up
Where this trial is running
Jakarta, DKI Jakarta
- National Cardiovascular Center Harapan Kita — Jakarta, DKI Jakarta, Indonesia (Recruiting)
Study contacts
- Study coordinator: Sisca Natalia Siagian, MD
- Email: sisca.ped.car@gmail.com
- Phone: +6281212716332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.