Clinical Characteristics and Associations of the "Good Fontan" Patient

Completed

• Conditions: Single-ventricle; Congenital Heart Disease

• Registration Number: NCT03470428
• Lead Sponsor: Boston Children's Hospital

Brief Summary

This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse event in their Fontan patients.

Detailed Description

This is a multi-center prospective study that involves collecting data from patients as well as their cardiology providers in order to determine whether there is correlation between patient-reported quality of life assessments and clinician-identified assessments of their patients. The study also involves collecting data from the medical records of participating patients and entering it into our study database.

Study Timeline

• Study Start: 2018-03-05
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-20
• Primary Completion: 2023-03-20
• Status Verified: 2023-04
• Study Completion: 2023-04-18
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Extracardiac or Lateral Funnel Fontan

Exclusion Criteria

• Currently being evaluated for or listed for cardiac transplant
• Underwent Fontan revision or conversion
• Currently pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surprise question	1 year	The ability of the cardiologist's response to the "surprise" question to predict adverse cardiac events within 1 year

Secondary Outcome Measures

Name	Time	Method
Clinical characteristics and associations of the "good Fontan"	1 year	Clinical characteristics and associations of this group (the "good Fontan") are different compared to those that are in the "at-risk" category (all others that do not fit into the "good Fontan" category). Data measurements will include relevant clinical data available for each patient, including but not limited to data from cardiac surgeries, catheterizations, MRIs, echocardiograms, exercise stress tests, current medications, labs, and patient responses to questionnaires.
Correlation between patient and provider assessments	1 year	There will be a positive correlation of the patient's own assessment of quality of life with the clinician-identified designation of a "good Fontan."
Clinician factors associated with adverse events conversation with patients	1 year	Clinician factors (years of experience, primary subspecialty, gender, parenthood) are associated with beliefs in regard to appropriate timing to discuss potential long-term adverse events to Fontan patients.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States