Clinical Characteristics and Associations of the "Good Fontan" Patient

NCT03470428 | Completed

• 1 other identifier: IRB-P00024716
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Single-ventricle

Keywords

Fontan; Single Ventricle

Outcome Measures

Primary Outcomes (1)

• Surprise question

  The ability of the cardiologist's response to the "surprise" question to predict adverse cardiac events within 1 year

  1 year

Secondary Outcomes (3)

• Clinical characteristics and associations of the "good Fontan"

  1 year

• Correlation between patient and provider assessments

  1 year

• Clinician factors associated with adverse events conversation with patients

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with congenital heart disease who have undergone the Fontan procedure.

You may qualify if:

• Extracardiac or Lateral Funnel Fontan

You may not qualify if:

• Currently being evaluated for or listed for cardiac transplant
• Underwent Fontan revision or conversion
• Currently pregnant

Sponsors & Collaborators

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

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

• 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.

  PMID: 17846297 BACKGROUND

• 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.

  PMID: 20929979 BACKGROUND

• 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.

  PMID: 24583501 BACKGROUND

• 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.

  PMID: 27695853 BACKGROUND

• 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.

  PMID: 26054631 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Univentricular Heart

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rahul Rathod, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 20, 2018
• Study Start: March 5, 2018
• Primary Completion: March 20, 2023
• Study Completion: April 18, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)