Relationship Between Functional Health Status and Ventricular Performance After Fontan--Pediatric Heart Network

NCT00132782 | Completed DMC

• 2 other identifiers: 242U01HL068270
• Study Type: observational
• Target: 546
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this cross-sectional study was to determine the interrelationships between health status and measures of cardiac performance in children 6 to 18 years of age with congenital heart disease who have undergone a Fontan procedure as surgical treatment for functional single ventricle. The goal was to develop a data set that will permit identification of a clinically relevant endpoint for subsequent trials of medical management of the Fontan patient.

Conditions

Defect, Congenital Heart; Arrhythmia

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects must have had Fontan surgery of any type at least 6 months prior to the time of testing

You may qualify if:

• Age 6 through 18 years at the time of enrollment.
• Fontan surgery of any type at least 6 months prior to the time of testing.
• Agreement and ability to have all of the following testing completed:
• An echocardiogram at the study center,
• Parent health status questionnaire, and
• Blood testing.
• Planned or ongoing cardiac care at the study center that will allow completion of study testing within 3 months of study enrollment.
• Informed consent of a parent or guardian, and assent of the study participant if he/she is able to provide it, according to institutional guidelines.

You may not qualify if:

• Non-cardiac medical or psychiatric disorder that would prevent successful completion of planned study testing or would invalidate the results of study testing.
• Ongoing or planned participation in another research protocol that would either prevent successful completion of planned study testing or invalidate the results of study testing.
• Lack of reading fluency by the primary caregiver in both English and Spanish, languages for which the parental report health status questionnaire has been validated.
• Pregnancy at the time of enrollment or pregnancy planned prior to completion of study testing.

Sponsors & Collaborators

• Carelon Research: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Pediatric Heart Network: collaborator

Related Publications (7)

• Atz AM, Zak V, Mahony L, Uzark K, D'agincourt N, Goldberg DJ, Williams RV, Breitbart RE, Colan SD, Burns KM, Margossian R, Henderson HT, Korsin R, Marino BS, Daniels K, McCrindle BW; Pediatric Heart Network Investigators. Longitudinal Outcomes of Patients With Single Ventricle After the Fontan Procedure. J Am Coll Cardiol. 2017 Jun 6;69(22):2735-2744. doi: 10.1016/j.jacc.2017.03.582.

  PMID: 28571639 DERIVED

• Margossian R, Sleeper LA, Pearson GD, Barker PC, Mertens L, Quartermain MD, Su JT, Shirali G, Chen S, Colan SD; Pediatric Heart Network Investigators. Assessment of Diastolic Function in Single-Ventricle Patients After the Fontan Procedure. J Am Soc Echocardiogr. 2016 Nov;29(11):1066-1073. doi: 10.1016/j.echo.2016.07.016. Epub 2016 Sep 10.

  PMID: 27624592 DERIVED

• Uzark K, Zak V, Shrader P, McCrindle BW, Radojewski E, Varni JW, Daniels K, Handisides J, Hill KD, Lambert LM, Margossian R, Pemberton VL, Lai WW, Atz AM; Pediatric Heart Network Investigators. Assessment of Quality of Life in Young Patients with Single Ventricle after the Fontan Operation. J Pediatr. 2016 Mar;170:166-72.e1. doi: 10.1016/j.jpeds.2015.11.016. Epub 2015 Dec 10.

  PMID: 26685073 DERIVED

• Atz AM, Zak V, Mahony L, Uzark K, Shrader P, Gallagher D, Paridon SM, Williams RV, Breitbart RE, Colan SD, Kaltman JR, Margossian R, Pasquali SK, Allen K, Lai WW, Korsin R, Marino BS, Mirarchi N, McCrindle BW; Pediatric Heart Network Investigators. Survival data and predictors of functional outcome an average of 15 years after the Fontan procedure: the pediatric heart network Fontan cohort. Congenit Heart Dis. 2015 Jan-Feb;10(1):E30-42. doi: 10.1111/chd.12193. Epub 2014 Jun 17.

  PMID: 24934522 DERIVED

• Atz AM, Travison TG, McCrindle BW, Mahony L, Glatz AC, Kaza AK, Breitbart RE, Colan SD, Kaltman JR, Margossian R, Pasquali SK, Wang Y, Gersony WM; Pediatric Heart Network Investigators. Cardiac performance and quality of life in patients who have undergone the Fontan procedure with and without prior superior cavopulmonary connection. Cardiol Young. 2013 Jun;23(3):335-43. doi: 10.1017/S1047951112001175. Epub 2012 Jul 24.

  PMID: 22824161 DERIVED

• Cohen MS, Zak V, Atz AM, Printz BF, Pinto N, Lambert L, Pemberton V, Li JS, Margossian R, Dunbar-Masterson C, McCrindle BW. Anthropometric measures after Fontan procedure: implications for suboptimal functional outcome. Am Heart J. 2010 Dec;160(6):1092-8, 1098.e1. doi: 10.1016/j.ahj.2010.07.039.

  PMID: 21146663 DERIVED

• Stephenson EA, Lu M, Berul CI, Etheridge SP, Idriss SF, Margossian R, Reed JH, Prakash A, Sleeper LA, Vetter VL, Blaufox AD; Pediatric Heart Network Investigators. Arrhythmias in a contemporary fontan cohort: prevalence and clinical associations in a multicenter cross-sectional study. J Am Coll Cardiol. 2010 Sep 7;56(11):890-6. doi: 10.1016/j.jacc.2010.03.079.

  PMID: 20813285 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lynn Sleeper, ScD

  Carelon Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 22, 2005
• Study Start: March 1, 2003
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: March 4, 2014

Record last verified: 2009-02