Clinical Characteristics and Associations of the "Good Fontan" Patient

Congenital Heart Disease Clinical Trial

Official title:

Clinical Characteristics and Associations of the "Good Fontan" Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470428
• Other study ID #: IRB-P00024716
• Status: Completed
• Start date: March 5, 2018
• Est. completion date: April 18, 2023

Study information

• Verified date: April 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: April 18, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Single-ventricle
• Univentricular Heart

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (10)

Lead Sponsor	Collaborator
Boston Children's Hospital	Child Heart Associates, Congenital Heart, Connecticut Children's Medical Center, Dartmouth College, Massachusetts General Hospital, New England Congenital Cardiology Association (NECCA), University of Massachusetts, Worcester, University of Vermont Children's Hospital, Yale University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surprise question	The ability of the cardiologist's response to the "surprise" question to predict adverse cardiac events within 1 year	1 year
Secondary	Clinical characteristics and associations of the "good Fontan"	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.	1 year
Secondary	Correlation between patient and provider assessments	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."	1 year
Secondary	Clinician factors associated with adverse events conversation with patients	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.	1 year