Clinical Characteristics and Associations of the "Good Fontan" Patient

• ClinicalTrials.gov Identifier: NCT03470428
• Recruitment Status: Active, not recruiting
• First Posted: March 20, 2018
• Last Update Posted: July 28, 2021
• Sponsor: Boston Children's Hospital
• 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

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 *

• d'Udekem Y, Iyengar AJ, Cochrane AD, Grigg LE, Ramsay JM, Wheaton GR, Penny DJ, Brizard CP. The Fontan procedure: contemporary techniques have improved long-term outcomes. Circulation. 2007 Sep 11;116(11 Suppl):I157-64. doi: 10.1161/CIRCULATIONAHA.106.676445.
• Diller GP, Giardini A, Dimopoulos K, Gargiulo G, Muller J, Derrick G, Giannakoulas G, Khambadkone S, Lammers AE, Picchio FM, Gatzoulis MA, Hager A. Predictors of morbidity and mortality in contemporary Fontan patients: results from a multicenter study including cardiopulmonary exercise testing in 321 patients. Eur Heart J. 2010 Dec;31(24):3073-83. doi: 10.1093/eurheartj/ehq356. Epub 2010 Oct 7.
• Blume ED, Balkin EM, Aiyagari R, Ziniel S, Beke DM, Thiagarajan R, Taylor L, Kulik T, Pituch K, Wolfe J. Parental perspectives on suffering and quality of life at end-of-life in children with advanced heart disease: an exploratory study*. Pediatr Crit Care Med. 2014 May;15(4):336-42. doi: 10.1097/PCC.0000000000000072.
• Lakin JR, Robinson MG, Bernacki RE, Powers BW, Block SD, Cunningham R, Obermeyer Z. Estimating 1-Year Mortality for High-Risk Primary Care Patients Using the "Surprise" Question. JAMA Intern Med. 2016 Dec 1;176(12):1863-1865. doi: 10.1001/jamainternmed.2016.5928. No abstract available.
• Hamano J, Morita T, Inoue S, Ikenaga M, Matsumoto Y, Sekine R, Yamaguchi T, Hirohashi T, Tajima T, Tatara R, Watanabe H, Otani H, Takigawa C, Matsuda Y, Nagaoka H, Mori M, Yamamoto N, Shimizu M, Sasara T, Kinoshita H. Surprise Questions for Survival Prediction in Patients With Advanced Cancer: A Multicenter Prospective Cohort Study. Oncologist. 2015 Jul;20(7):839-44. doi: 10.1634/theoncologist.2015-0015. Epub 2015 Jun 8.

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

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