Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD

Recruiting now

Conditions studied: Congenital Heart Disease (CHD), Univentricular Heart

In brief

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.

Key facts

Study ID

NCT07535203

Run by

Sisca Natalia Siagian

People needed

52

Starts

2025-01-01

Expected to finish

2027-06-01

Last updated by the study team

2026-04-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed cyanotic CHD
• Univentricular heart physiology
• Planned staged palliation including Fontan procedure
• Informed consent obtained (patient or guardian)

You may not qualify if…

• Refusal to participate
• Incomplete clinical data
• Inability to complete follow-up

Where it is running

• National Cardiovascular Center Harapan Kita — Jakarta, DKI Jakarta, Indonesia (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.