Fontan outcomes with low versus high lung blood flow in single‑ventricle hearts
Official title: Comparison of Outcomes of Pulmonary Oligemia Versus Pulmonary Plethora in Cyanotic Congenital Heart Disease With Univentricular Heart After Fontan Procedure
Run by National Cardiovascular Center Harapan Kita Hospital Indonesia · NCT07535203 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | National Cardiovascular Center Harapan Kita Hospital Indonesia Academic / other |
| Locations | 1 site (Jakarta, DKI Jakarta) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | March 1, 2027 |
| Study ends | June 2027 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT07535203 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Improving transition of congenital heart disease care from pediatric to adult services
This program will try a multi-step transfer process to reduce health declines in people with congenital heart disease who are waiting to see an adult specialist.
-
HeartGPS: Prenatal mental health support for mothers of babies with CHD
A pregnant person or mother of a baby with congenital heart disease will try a virtual mental health program (HeartGPS) in addition to standard care to see if it helps with well‑being and infant development.
-
Direct breastfeeding to support babies with congenital heart disease and their families
This study tests a breastfeeding-focused program to help infants with CHD breastfeed directly and see how it affects infant health and parental well-being.
-
Music and Multisensory Interventions for Pain During Chest Tube Removal in Infants with Congenital Heart Disease
This trial tests whether music or a multisensory mobile intervention can reduce pain and stabilize physiology during chest tube removal in 2- to 12-month-old infants with congenital heart disease.
-
MedlyPeds: a smartphone app to monitor kids with heart disease
This study tests whether the MedlyPeds app can help kids with heart conditions and their families stay informed and track symptoms remotely.
-
Coughing exercises versus incentive spirometry for breathing recovery after pediatric heart surgery
This study will test whether coughing exercises or incentive spirometry help children aged 6–18 recover their breathing and lung function after heart surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.