Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSisca Natalia Siagian
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed cyanotic CHD
Univentricular heart physiology
Planned staged palliation including Fontan procedure
Informed consent obtained (patient or guardian)
Disqualifiers
Refusal to participate
Incomplete clinical data
Inability to complete follow-up
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Fontan Procedure
Procedure/SurgeryStandard staged palliation including Bidirectional Glenn and Fontan procedure. No experimental intervention; observational classification only.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Pulmonary Oligemia1 intervention
Group B: Pulmonary Plethora1 intervention
Trial outcomes
Primary outcomes
1
Mortality
All-cause mortality following completion of Fontan procedure.
Time frame
From recruitment through study completion (an average of 1 year post-Fontan)Secondary outcomes
1
Number of Participants with Postoperative Complications
Assessment of postoperative morbidity defined as the occurrence of complications (e.g., arrhythmia, infection, thrombosis, or other clinically significant adverse events) following the Fontan procedure. Measurement Tool: Clinical assessment and medical record review Unit of Measure: Number of participants with ≥1 complication
Time frame
From Fontan procedure through study completion (up to 12 months post-Fontan)2
Number of Participants with Rehospitalization
Assessment of rehospitalization defined as any unplanned hospital admission after discharge following the Fontan procedure. Measurement Tool: Medical record review Unit of Measure: Number of participants rehospitalized (≥1 admission)
Time frame
From hospital discharge post-Fontan through study completion (up to 12 months post-Fontan)3
Concentration of Activin-A in Blood
Measurement of circulating Activin-A concentration as a biomarker of pulmonary vascular remodeling and inflammation in patients with univentricular congenital heart disease undergoing staged palliation. Blood samples will be collected at predefined perioperative time points. Measurement Tool: Enzyme-linked immunosorbent assay (ELISA) or equivalent validated immunoassay Unit of Measure: Picograms per milliliter (pg/mL)
Time frame
Baseline (pre-BCPS procedure), Perioperative at Stage II (Bidirectional Cavopulmonary Shunt [BCPS]), Perioperative at Stage III (Fontan procedure)4
Concentration of Activin-A in Pulmonary Artery Tissue
Measurement of Activin-A concentration in pulmonary artery tissue obtained during surgical procedures, reflecting local vascular remodeling and inflammatory activity. Measurement Tool: Enzyme-linked immunosorbent assay (ELISA) or equivalent validated immunoassay on homogenized tissue samples Unit of Measure: Picograms per milligram of tissue (pg/mg)
Time frame
- 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 collectionSponsors and contacts
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Sisca Natalia Siagian
Lead sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor institution
LMU Klinikum
Collaborator
Fakultas Kedokteran Universitas Indonesia
Collaborator
National Cardiovascular Center Harapan Kita Hospital Indonesia
Collaborator
Source ClinicalTrials.gov