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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

Tracking Information
First Submitted Date March 6, 2018
First Posted Date March 20, 2018
Last Update Posted Date July 28, 2021
Actual Study Start Date March 5, 2018
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 16, 2018)
  • 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.
  • 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."
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Characteristics and Associations of the "Good Fontan" Patient
Official Title Clinical Characteristics and Associations of the "Good Fontan" Patient
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with congenital heart disease who have undergone the Fontan procedure.
Condition
  • Congenital Heart Disease
  • Single-ventricle
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: March 16, 2018)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2026
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03470428
Other Study ID Numbers IRB-P00024716
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Rahul Rathod, Boston Children's Hospital
Original Responsible Party Same as current
Current Study Sponsor Boston Children's Hospital
Original Study Sponsor Same as current
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
Investigators
Principal Investigator: Rahul Rathod, MD Boston Children's Hospital
PRS Account Boston Children's Hospital
Verification Date July 2021