Clinical trial NCT03470428: Clinical Characteristics and Associations of the "Good Fontan" Patient
Official title: Clinical Characteristics and Associations of the "Good Fontan" Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Single-ventricle
Keywords: Fontan
Single Ventricle
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: New England Congenital Cardiology Association (NECCA)
name: Yale University
name: Dartmouth College
name: Connecticut Children's Medical Center
name: University of Vermont
name: Child Heart Associates
name: Congenital Heart
name: University of Massachusetts, Worcester
name: Massachusetts General Hospital
First posted: 2018-03-20
Enrollment: 146
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with congenital heart disease who have undergone the Fontan procedure.

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.

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

Primary outcomes:
measure: Surprise question
timeFrame: 1 year
Secondary outcomes:
measure: Clinical characteristics and associations of the "good Fontan"
timeFrame: 1 year
measure: Correlation between patient and provider assessments
timeFrame: 1 year
measure: Clinician factors associated with adverse events conversation with patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Rahul Rathod, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.