Clinical Characteristics and Associations of the "Good Fontan" Patient

Boston Children's Hospital146 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

146

Conditions

Congenital Heart Disease Single-ventricle

Eligibility

Sex: ALLMin age: 10 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Surprise question

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

Time frame: 1 year

Secondary Outcomes

Clinical characteristics and associations of the "good Fontan"

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.

Time frame: 1 year

Correlation between patient and provider assessments

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."

Time frame: 1 year

Clinician factors associated with adverse events conversation with patients

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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