Clinical Characteristics and Associations of the "Good Fontan" Patient
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Primary Outcome Measures
- Surprise question [1 year]
The ability of the cardiologist's response to the "surprise" question to predict adverse cardiac events within 1 year
Secondary Outcome Measures
- Clinical characteristics and associations of the "good Fontan" [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 [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 [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
Criteria
Inclusion Criteria:
- Extracardiac or Lateral Funnel Fontan
Exclusion Criteria:
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Currently being evaluated for or listed for cardiac transplant
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Underwent Fontan revision or conversion
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Currently pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
- Principal Investigator: Rahul Rathod, MD, Boston Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Diller GP, Giardini A, Dimopoulos K, Gargiulo G, Müller 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.
- 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.
- 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.
- 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.
- IRB-P00024716