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Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD

NCT07535203 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2026-04-17

No results posted yet for this study

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

Interventions

PROCEDURE

Fontan Procedure

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

Sponsors & Collaborators

  • LMU Klinikum

    collaborator OTHER

  • Fakultas Kedokteran Universitas Indonesia

    collaborator OTHER

  • National Cardiovascular Center Harapan Kita Hospital Indonesia

    collaborator OTHER

  • Sisca Natalia Siagian

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-03-01
Completion
2027-06-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07535203 on ClinicalTrials.gov