Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD

NCT07535203 | Recruiting DMC

• 1 other identifier: DP.04.03/D.XIII/6681/2025
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Congenital Heart Disease (CHD); Univentricular Heart

Keywords

univentricular heart; congenital heart disease; fontan procedure; pulmonary blood flow; oligemia; plethora; pulmonary hemodynamics

Outcome Measures

Primary Outcomes (1)

• Mortality

  All-cause mortality following completion of Fontan procedure.

  From recruitment through study completion (an average of 1 year post-Fontan)

Secondary Outcomes (17)

• Number of Participants with Postoperative Complications

  From Fontan procedure through study completion (up to 12 months post-Fontan)

• Number of Participants with Rehospitalization

  From hospital discharge post-Fontan through study completion (up to 12 months post-Fontan)

• Concentration of Activin-A in Blood

  Baseline (pre-BCPS procedure), Perioperative at Stage II (Bidirectional Cavopulmonary Shunt [BCPS]), Perioperative at Stage III (Fontan procedure)

• Concentration of Activin-A in Pulmonary Artery Tissue

  - At time of tissue collection during Stage II (Bidirectional Cavopulmonary Shunt [BCPS]) - At time of tissue collection during Stage III (Fontan procedure) Analysis performed within 1 month after each collection

• Distance Covered in Six-Minute Walk Test (6MWT)

  Follow-up (6 months post-Fontan procedure)

Study Arms (2)

Pulmonary Oligemia

Patients with cyanotic CHD and univentricular physiology characterized by reduced pulmonary blood flow.

Procedure: Fontan Procedure

Pulmonary Plethora

Patients with cyanotic CHD and univentricular physiology characterized by increased pulmonary blood flow.

Procedure: Fontan Procedure

Interventions

Fontan Procedure PROCEDURE

Standard staged palliation including Bidirectional Glenn and Fontan procedure. No experimental intervention; observational classification only.

Pulmonary Oligemia; Pulmonary Plethora

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will involve a cohort of clinically diagnosed patients with univentricular heart physiology who are undergoing the Fontan procedure as their final intervention.

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

Sponsors & Collaborators

• Sisca Natalia Siagian: lead
• LMU Klinikum: collaborator
• Fakultas Kedokteran Universitas Indonesia: collaborator
• National Cardiovascular Center Harapan Kita Hospital Indonesia: collaborator

Study Sites (1)

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, 11420, Indonesia

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Univentricular Heart; Hypovolemia

Interventions

Fontan Procedure

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Bypass, Right; Anastomosis, Surgical; Surgical Procedures, Operative; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Norwood Procedures; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Central Study Contacts

Sisca Natalia Siagian, MD

CONTACT

+6281212716332; sisca.ped.car@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Sponsor

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 17, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)