ArticleAmerican heart journal2006
Design of a large cross-sectional study to facilitate future clinical trials in children with the Fontan palliation.
Article in American heart journal, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
39 citing papers in PubMed, 61 citations in OpenAlex.
- Revisiting the Effect of Udenafil on Exercise Performance in Patients With Fontan Circulation: Results of a Post Hoc Analysis of the FUEL Trial.Journal of the American Heart Association · 2025Trial
- Results of the FUEL Trial.Circulation · 2020Trial
- Assessment of Diastolic Function in Single-Ventricle Patients After the Fontan Procedure.Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography · 2016Trial
- Factors impacting echocardiographic imaging after the Fontan procedure: a report from the pediatric heart network fontan cross-sectional study.Echocardiography (Mount Kisco, N.Y.) · 2013Trial
- Cardiac performance and quality of life in patients who have undergone the Fontan procedure with and without prior superior cavopulmonary connection.Cardiology in the young · 2013Trial
- Practice variability and outcomes of coil embolization of aortopulmonary collaterals before Fontan completion: a report from the Pediatric Heart Network Fontan Cross-Sectional Study.American heart journal · 2011Trial
- Anthropometric measures after Fontan procedure: implications for suboptimal functional outcome.American heart journal · 2010Trial
- Rationale and design of a trial of angiotensin-converting enzyme inhibition in infants with single ventricle.American heart journal · 2009Trial
- Collaborating to Improve Outcomes in Congenital Heart Disease: The Pediatric Heart Network Experience.Congenital heart disease · 2025Article
- Long-term Outcomes of Fontan Operation in Korea: Different Regions, Different Patients, Different Prognostic Factors?Korean circulation journal · 2024Article
- The Long-term Outcomes and Risk Factors of Complications After Fontan Surgery: From the Korean Fontan Registry (KFR).Korean circulation journal · 2024Article
- Deriving fontan-specific normative exercise data from well-functioning adolescents.International journal of cardiology. Congenital heart disease · 2024Article
- Association of patient-level characteristics with long-term outcomes after Fontan palliation: Rationale, design, and baseline characteristics of the Pediatric Cardiac Care Consortium Fontan cohort study.American heart journal · 2024Article
- Diastolic Dysfunction With Preserved Ejection Fraction After the Fontan Procedure.Journal of the American Heart Association · 2022Article
- Association Between Sleep Disturbances With Neurodevelopmental Problems and Decreased Health-Related Quality of Life in Children With Fontan Circulation.Journal of the American Heart Association · 2021Article
- A multi-national trial of a direct oral anticoagulant in children with cardiac disease: Design and rationale of the Safety of ApiXaban On Pediatric Heart disease On the preventioN of Embolism (SAXOPHONE) study.American heart journal · 2019Article
- Design and rationale of the Fontan Udenafil Exercise Longitudinal (FUEL) trial.American heart journal · 2018Review
- Longitudinal Outcomes of Patients With Single Ventricle After the Fontan Procedure.Journal of the American College of Cardiology · 2017Article
- The pediatric heart network: meeting the challenges to multicenter studies in pediatric heart disease.Current opinion in pediatrics · 2015Review
- Functional health status in children and adolescents after Fontan: comparison of generic and disease-specific assessments.Cardiology in the young · 2014Observational
Corrections and comments
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Authors and funding
12 authors at 10 institutions in 2 countries.
Funding
Abstract
backgroundClinical trials in children with congenital heart disease are often limited by the absence of the following: (1) a primary outcome that can be observed in a reasonable period; (2) information regarding health-related quality of life; (3) knowledge of the correlation between health status and ventricular function and exercise performance; (4) a sufficient number of children at a single institution to provide adequate statistical power; and (5) procedural and management differences between and within institutions.
methodsThe NHLBI-funded Pediatric Heart Network designed a cross-sectional study of children aged 6 to 18 years, from 7 pediatric clinical centers, who had undergone a Fontan procedure as treatment for congenital heart disease. Health-related quality of life was measured by the Child Health Questionnaire and the Congenital Heart Adolescent and Teenager Questionnaire. Ventricular function was assessed by maximal exercise testing, echocardiography, cardiac magnetic resonance imaging, and B-type natriuretic peptide. The study was designed to detect a correlation of R > or = 0.30 between health status scores and measures of ventricular function and performance in a subcohort with all study measures completed.
resultsA total of 1078 children were screened by chart review; 644 (60%) were eligible. The consent rate was 85% and 546 children were enrolled. Acquisition of echocardiograms, B-type natriuretic peptide, and health status was > or = 94%; completion rates were lower for maximal exercise testing (76%) and cardiac magnetic resonance imaging (41%).
conclusionsThis large study provides unique information regarding the relationship between health status and clinical measures in post-Fontan patients that will facilitate the design of future randomized trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.