Congenital Heart Disease (CHD)NCT07535203
Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD
An observational study of Congenital Heart Disease (CHD) and Univentricular Heart, run by Sisca Natalia Siagian at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease (CHD), Univentricular Heart
- What is being tested?
- Fontan Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Diagnosed cyanotic CHD
- Univentricular heart physiology
- Planned staged palliation including Fontan procedure
- Informed consent obtained (patient or guardian)
Who cannot join
- Refusal to participate
- Incomplete clinical data
- Inability to complete follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
National Cardiovascular Center Harapan Kita
Jakarta, DKI Jakarta, 11420
Sisca Natalia Siagian, MD, +6281212716332, sisca.ped.car@gmail.com
About this study
Official title: Comparison of Outcomes of Pulmonary Oligemia Versus Pulmonary Plethora in Cyanotic Congenital Heart Disease With Univentricular Heart After Fontan Procedure
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.
Read the detailed description
Univentricular heart physiology represents a complex form of congenital heart disease requiring staged surgical palliation. The Fontan procedure has improved survival; however, outcomes remain variable and are influenced by pulmonary vascular conditions. Pulmonary blood flow abnormalities-oligemia (reduced flow) and plethora (increased flow)-may affect lung development from fetal life. Oligemia has been associated with pulmonary hypoplasia, impaired alveolar formation, and increased pulmonary vascular resistance, which may adversely affect Fontan circulation.
This prospective cohort study aims to compare outcomes between patients with oligemia and those with plethora. Participants will undergo standard clinical care, including staged procedures (Bidirectional Glenn and Fontan), and comprehensive assessments (clinical, laboratory, imaging, and hemodynamic). Follow-up will be conducted for approximately 1.5 years post-Fontan.
The study will evaluate mortality, morbidity, pulmonary hemodynamics, biomarkers (NT-proBNP, ET-1, Activin-A), exercise capacity, neurocognitive outcomes, and quality of life. Findings are expected to improve risk stratification and management strategies in univentricular CHD.
- Being tested
- Fontan Procedure
- Keywords
- univentricular heart, congenital heart disease, fontan procedure, pulmonary blood flow, oligemia, plethora, pulmonary hemodynamics
- Medical subject headings
- Heart Defects, Congenital, Univentricular Heart, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fontan ProcedureProcedure or surgery
Standard staged palliation including Bidirectional Glenn and Fontan procedure. No experimental intervention; observational classification only.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Oligemia | Patients with cyanotic CHD and univentricular physiology characterized by reduced pulmonary blood flow. Receives: Procedure: Fontan Procedure | |
| Pulmonary Plethora | Patients with cyanotic CHD and univentricular physiology characterized by increased pulmonary blood flow. Receives: Procedure: Fontan Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause mortality following completion of Fontan procedure.
Measured: From recruitment through study completion (an average of 1 year post-Fontan)
Secondary outcomes (17)
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
Measured: From Fontan procedure through study completion (up to 12 months post-Fontan)
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)
Measured: From hospital discharge post-Fontan through study completion (up to 12 months post-Fontan)
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)
Measured: 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
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)
Measured: - 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)
Assessment of functional exercise capacity using the six-minute walk test (6MWT), performed according to standardized protocol.
Measurement Tool: Six-minute walk test (6MWT) Unit of Measure: Distance in meters (m) Interpretation: More distance covered means higher exercise capacity
Measured: Follow-up (6 months post-Fontan procedure)
Neurodevelopmental Score Using Bayley Scales of Infant and Toddler Development, Fourth Edition (BSID-IV)
Assessment of neurocognitive and developmental function in pediatric patients using the Bayley Scales of Infant and Toddler Development, Fourth Edition (BSID-IV). The instrument evaluates multiple domains including cognitive, language (receptive and expressive), motor (fine and gross), social-emotional, and adaptive behavior. Raw scores are converted into standardized composite scores based on age-specific norms.
Measurement Tool:
Bayley Scales of Infant and Toddler Development, Fourth Edition (BSID-IV)
Unit of Measure:
Standard score (composite score), typically ranging from 40 to 160, with a mean of 100 and standard deviation of 15 Higher scores indicate better neurodevelopmental performance
Measured: Follow-up (6 months post-Fontan procedure)
Cognitive Function Score Using Montreal Cognitive Assessment (MoCA)
Assessment of cognitive function in adult patients using the Montreal Cognitive Assessment (MoCA), a screening tool evaluating domains including memory, executive function, attention, language, visuospatial ability, and orientation.
Measurement Tool:
Montreal Cognitive Assessment (MoCA)
Unit of Measure:
Score on a scale from 0 to 30, where higher scores indicate better cognitive function; a score of 26 or above is considered normal
Measured: Follow-up (6 months post-Fontan Procedure)
Quality of Life Score Using Child Health Questionnaire (CHQ)
Assessment of quality of life in pediatric patients using the Child Health Questionnaire (CHQ). The instrument evaluates multiple health domains, which are aggregated into Physical Health Summary (PhS) and Psychosocial Summary (PsS) scores.
Measurement Tool: Child Health Questionnaire (CHQ) Unit of Measure: Score on a scale from 0 to 100 (higher scores indicate better health status)
Measured: Follow-up (6 months post-Fontan procedure)
Quality of Life Score Using 36-Item Short Form Survey (SF-36)
Assessment of quality of life in adult patients using the 36-item Short Form Survey (SF-36). The instrument includes 8 domains aggregated into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.
Measurement Tool: 36-item Short Form Survey (SF-36) Unit of Measure: Score on a scale from 0 to 100 (higher scores indicate better health status)
Measured: Follow-up (6 months post-Fontan Procedure)
Histopathological Score of Pulmonary Artery Remodeling Using Hematoxylin and Eosin (H&E) Staining
Semi-quantitative assessment of pulmonary artery structural changes (e.g., medial hypertrophy, intimal proliferation, luminal narrowing) using Hematoxylin and Eosin (H\&E) staining. A standardized Pulmonary Artery Remodeling Histopathological Scoring System is used to grade the severity of vascular changes.
Measurement Tool:
Light microscopy using a semi-quantitative histopathological scoring system
Unit of Measure:
Score on a scale from 0 to 3, where:
0 = no structural abnormality
- = mild remodeling
- = moderate remodeling
- = severe remodeling Higher scores indicate worse pulmonary artery remodeling
Measured: At time of tissue collection during BCPS and Fontan procedures; analysis performed within 1 month after each collection
Percentage of Collagen Deposition Using Masson's Trichrome Staining
Quantification of collagen accumulation in pulmonary artery tissue using Masson's Trichrome staining, analyzed via digital image analysis software.
Measurement Tool: Image analysis software (e.g., ImageJ or equivalent) Unit of Measure: Percentage (%) of stained area per total vessel area
Measured: At time of tissue collection during BCPS and Fontan procedures; analysis performed within 1 month after each collection
Elastin Density Measured by Verhoeff-Van Gieson (VVG) Staining
Evaluation of elastin fiber integrity and distribution in pulmonary artery tissue using Elastica Van Gieson staining.
Measurement Tool: Microscopy with image analysis Unit of Measure: Percentage (%) elastin-positive area
Measured: At time of tissue collection during BCPS and Fontan procedures; analysis performed within 1 month after each collection
Percentage of PAS-Positive Area in Pulmonary Artery Tissue
Assessment of glycoprotein/glycogen and basement membrane components using Periodic Acid-Schiff (PAS) staining.
Measurement Tool: Microscopy with quantitative image analysis Unit of Measure: Percentage (%) PAS-positive area
Measured: At time of tissue collection during BCPS and Fontan procedures; analysis performed within 1 month after each collection
Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization
Measurement of mean pulmonary artery pressure (mPAP) obtained from right heart catheterization to assess pulmonary hemodynamics.
Measurement Tool: Right heart catheterization Unit of Measure: Millimeters of mercury (mmHg)
Measured: Baseline, Post-BCPS preparing for Fontan (average of 3 months post-BCPS procedure), Follow-up (average of 6 months post-Fontan procedure)
Pulmonary Vascular Resistance Measured by Right Heart Catheterization
Calculation of pulmonary vascular resistance (PVR) derived from catheterization data using standard hemodynamic formulas.
Measurement Tool: Right heart catheterization with hemodynamic calculation Unit of Measure: Wood units (WU)
Measured: Baseline, Post-BCPS preparing for Fontan (average of 3 months post-BCPS procedure), Follow-up (average of 6 months post-Fontan procedure)
McGoon Ratio Assessed by Angiography
Evaluation of pulmonary artery size using the McGoon ratio, calculated as the sum of the diameters of the right and left pulmonary arteries divided by the diameter of the descending aorta, measured from angiographic images.
Measurement Tool: Angiography with standardized measurement method Unit of Measure: Ratio (unitless)
Measured: Baseline, Post-BCPS preparing for Fontan (average of 3 months post-BCPS procedure), Follow-up (average of 6 months post-Fontan procedure)
Nakata Index Measured by Angiography
Quantification of pulmonary artery size using the Nakata index, calculated as the sum of cross-sectional areas of the right and left pulmonary arteries normalized to body surface area.
Measurement Tool: Angiography with body surface area calculation Unit of Measure: mm²/m²
Measured: Baseline, Post-BCPS preparing for Fontan (average of 3 months post-BCPS procedure), Follow-up (average of 6 months post-Fontan procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Jan 2025
- Primary completion1 Mar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisca Natalia Siagian
- Sponsor type
- University, hospital or other
- Collaborators
- LMU Klinikum, Fakultas Kedokteran Universitas Indonesia, National Cardiovascular Center Harapan Kita Hospital Indonesia
- Responsible party
- Sponsor-investigator, Sisca Natalia Siagian, National Cardiovascular Center Harapan Kita Hospital Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535203
- Sponsor's protocol ID
- DP.04.03/D.XIII/6681/2025
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared. Data may be available upon reasonable request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Pulmonary Oligemia Versus Pulmonary Plethora in Cyanotic Congenital Heart Disease With Univentricular Heart After Fontan Procedure
- ClinicalTrials.gov ID
- NCT07535203
- Acronym / sponsor ID
- DP.04.03/D.XIII/6681/2025
- Keywords
- univentricular heart, congenital heart disease, fontan procedure, pulmonary blood flow, oligemia, plethora, pulmonary hemodynamics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sisca Natalia SiagianUniversity, hospital or other
- Collaborators
- LMU Klinikum, Fakultas Kedokteran Universitas Indonesia, National Cardiovascular Center Harapan Kita Hospital Indonesia
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Univentricular heart physiology represents a complex form of congenital heart disease requiring staged surgical palliation. The Fontan procedure has improved survival; however, outcomes remain variable and are influenced by pulmonary vascular conditions. Pulmonary blood flow abnormalities-oligemia (reduced flow) and plethora (increased flow)-may affect lung development from fetal life. Oligemia has been associated with pulmonary hypoplasia, impaired alveolar formation, and increased pulmonary vascular resistance, which may adversely affect Fontan circulation.
This prospective cohort study aims to compare outcomes between patients with oligemia and those with plethora. Participants will undergo standard clinical care, including staged procedures (Bidirectional Glenn and Fontan), and comprehensive assessments (clinical, laboratory, imaging, and hemodynamic). Follow-up will be conducted for approximately 1.5 years post-Fontan.
The study will evaluate mortality, morbidity, pulmonary hemodynamics, biomarkers (NT-proBNP, ET-1, Activin-A), exercise capacity, neurocognitive outcomes, and quality of life. Findings are expected to improve risk stratification and management strategies in univentricular CHD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Oligemia | – | Procedure: Fontan ProcedurePatients with cyanotic CHD and univentricular physiology characterized by reduced pulmonary blood flow. |
| Pulmonary Plethora | – | Procedure: Fontan ProcedurePatients with cyanotic CHD and univentricular physiology characterized by increased pulmonary blood flow. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Diagnosed cyanotic CHD
- Univentricular heart physiology
- Planned staged palliation including Fontan procedure
- Informed consent obtained (patient or guardian)
Key exclusion criteria (3 listed)
- Refusal to participate
- Incomplete clinical data
- Inability to complete follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fontan ProcedureStandard staged palliation including Bidirectional Glenn and Fontan procedure. No experimental intervention; observational classification only. | Procedure or surgery | Pulmonary Oligemia, Pulmonary Plethora |
Primary outcome
Mortality
Time frame: From recruitment through study completion (an average of 1 year post-Fontan)
All-cause mortality following completion of Fontan procedure.
17 secondary outcomes
Number of Participants with Postoperative Complications
Time frame: From Fontan procedure through study completion (up to 12 months post-Fontan)
Number of Participants with Rehospitalization
Time frame: From hospital discharge post-Fontan through study completion (up to 12 months post-Fontan)
Concentration of Activin-A in Blood
Time frame: 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
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 collection
Distance Covered in Six-Minute Walk Test (6MWT)
Time frame: Follow-up (6 months post-Fontan procedure)
Neurodevelopmental Score Using Bayley Scales of Infant and Toddler Development, Fourth Edition (BSID-IV)
Time frame: Follow-up (6 months post-Fontan procedure)
Cognitive Function Score Using Montreal Cognitive Assessment (MoCA)
Time frame: Follow-up (6 months post-Fontan Procedure)
Quality of Life Score Using Child Health Questionnaire (CHQ)
Time frame: Follow-up (6 months post-Fontan procedure)
Quality of Life Score Using 36-Item Short Form Survey (SF-36)
Time frame: Follow-up (6 months post-Fontan Procedure)
Histopathological Score of Pulmonary Artery Remodeling Using Hematoxylin and Eosin (H&E) Staining
Time frame: At time of tissue collection during BCPS and Fontan procedures; analysis performed within 1 month after each collection
Percentage of Collagen Deposition Using Masson's Trichrome Staining
Time frame: At time of tissue collection during BCPS and Fontan procedures; analysis performed within 1 month after each collection
Elastin Density Measured by Verhoeff-Van Gieson (VVG) Staining
Time frame: At time of tissue collection during BCPS and Fontan procedures; analysis performed within 1 month after each collection
Percentage of PAS-Positive Area in Pulmonary Artery Tissue
Time frame: At time of tissue collection during BCPS and Fontan procedures; analysis performed within 1 month after each collection
Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization
Time frame: Baseline, Post-BCPS preparing for Fontan (average of 3 months post-BCPS procedure), Follow-up (average of 6 months post-Fontan procedure)
Pulmonary Vascular Resistance Measured by Right Heart Catheterization
Time frame: Baseline, Post-BCPS preparing for Fontan (average of 3 months post-BCPS procedure), Follow-up (average of 6 months post-Fontan procedure)
McGoon Ratio Assessed by Angiography
Time frame: Baseline, Post-BCPS preparing for Fontan (average of 3 months post-BCPS procedure), Follow-up (average of 6 months post-Fontan procedure)
Nakata Index Measured by Angiography
Time frame: Baseline, Post-BCPS preparing for Fontan (average of 3 months post-BCPS procedure), Follow-up (average of 6 months post-Fontan procedure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared. Data may be available upon reasonable request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease (CHD) and Univentricular Heart, run by Sisca Natalia Siagian at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sisca Natalia Siagian, MD (+6281212716332, sisca.ped.car@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From recruitment through study completion (an average of 1 year post-Fontan)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.