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

Qualifiers

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 design

Treatments tested in this trial

  • Fontan Procedure

Treatment groups

52 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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