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Clinical Characteristics and Associations of the "Good Fontan" Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03470428
Recruitment Status : Active, not recruiting
First Posted : March 20, 2018
Last Update Posted : July 28, 2021
Sponsor:
Collaborators:
New England Congenital Cardiology Association (NECCA)
Yale University
Dartmouth College
Connecticut Children's Medical Center
University of Vermont Children's Hospital
Child Heart Associates
Congenital Heart
University of Massachusetts, Worcester
Massachusetts General Hospital
Information provided by (Responsible Party):
Rahul Rathod, Boston Children's Hospital

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Congenital Heart Disease Single-ventricle

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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Characteristics and Associations of the "Good Fontan" Patient
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Pediatric Fontan Patients
Participants ages 10 to 18 who have had Lateral Tunnel or Extracardiac Fontan procedures.
Adult Fontan Patients
Participants ages 18 to 60 who have had Lateral Tunnel or Extracardiac Fontan procedures.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with congenital heart disease who have undergone the Fontan procedure.
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470428


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
New England Congenital Cardiology Association (NECCA)
Yale University
Dartmouth College
Connecticut Children's Medical Center
University of Vermont Children's Hospital
Child Heart Associates
Congenital Heart
University of Massachusetts, Worcester
Massachusetts General Hospital
Investigators
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Principal Investigator: Rahul Rathod, MD Boston Children's Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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Responsible Party: Rahul Rathod, Cardiologist, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03470428    
Other Study ID Numbers: IRB-P00024716
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rahul Rathod, Boston Children's Hospital:
Fontan
Single Ventricle
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Univentricular Heart
 Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities