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OpenTrials
Completed

NCT Number: NCT03470428

Clinical Characteristics and Associations of the "Good Fontan" Patient

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Single-ventricle Univentricular Heart

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Surprise question

    Time frame: 1 year

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

Secondary outcomes

  1. Clinical characteristics and associations of the "good Fontan"

    Time frame: 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.

  2. Correlation between patient and provider assessments

    Time frame: 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."

  3. Clinician factors associated with adverse events conversation with patients

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Child Heart Associates
  • Congenital Heart
  • Connecticut Children's Medical Center
  • Dartmouth College
  • Massachusetts General Hospital
  • New England Congenital Cardiology Association (NECCA)
  • University of Massachusetts, Worcester
  • University of Vermont
  • Yale University

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2018
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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