NCT07535203 Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD
| NCT ID | NCT07535203 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sisca Natalia Siagian |
| Condition | Congenital Heart Disease (CHD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 52 participants in total. It began in 2025-01-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07535203 clinical trial?
This trial is open to participants of all sexes, studying Congenital Heart Disease (CHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07535203 currently recruiting?
Yes, NCT07535203 is actively recruiting participants. Contact the research team at sisca.ped.car@gmail.com for enrollment information.
Where is the NCT07535203 trial being conducted?
This trial is being conducted at Jakarta, Indonesia.
Who is sponsoring the NCT07535203 clinical trial?
NCT07535203 is sponsored by Sisca Natalia Siagian. The trial plans to enroll 52 participants.