Trial reportAmerican heart journal2009
Rationale and design of a trial of angiotensin-converting enzyme inhibition in infants with single ventricle.
Trial report in American heart journal, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 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
21 citing papers in PubMed, 35 citations in OpenAlex.
- Comparison of echocardiographic measurements to invasive measurements of diastolic function in infants with single ventricle physiology: a report from the Pediatric Heart Network Infant Single Ventricle Trial.Cardiology in the young · 2019Trial
- Passive range of motion exercise to enhance growth in infants following the Norwood procedure: a safety and feasibility trial.Cardiology in the young · 2017Trial
- Growth Asymmetry, Head Circumference, and Neurodevelopmental Outcomes in Infants with Single Ventricles.The Journal of pediatrics · 2016Trial
- Trial
- Factors associated with serum B-type natriuretic peptide in infants with single ventricles.Pediatric cardiology · 2014Trial
- Superior cavopulmonary anastomosis timing and outcomes in infants with single ventricle.The Journal of thoracic and cardiovascular surgery · 2013Trial
- Association of impaired linear growth and worse neurodevelopmental outcome in infants with single ventricle physiology: a report from the pediatric heart network infant single ventricle trial.The Journal of pediatrics · 2013Trial
- A predictive model for neurodevelopmental outcome after the Norwood procedure.Pediatric cardiology · 2013Trial
- Factors affecting growth in infants with single ventricle physiology: a report from the Pediatric Heart Network Infant Single Ventricle Trial.The Journal of pediatrics · 2011Trial
- Reporting adverse events in a surgical trial for complex congenital heart disease: the Pediatric Heart Network experience.The Journal of thoracic and cardiovascular surgery · 2011Trial
- Renin-angiotensin-aldosterone genotype influences ventricular remodeling in infants with single ventricle.Circulation · 2011Trial
- Enalapril in infants with single ventricle: results of a multicenter randomized trial.Circulation · 2010Trial
- Genetic and clinical variables act synergistically to impact neurodevelopmental outcomes in children with single ventricle heart disease.Communications medicine · 2023Article
- Translating clinical trials into clinical practice: a survey assessing the potential impact of the Pediatric Heart Network Infant Single Ventricle Trial.Cardiology in the young · 2017Article
- The Effect of the Superior Cavopulmonary Anastomosis on Ventricular Remodeling in Infants with Single Ventricle.Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography · 2017Article
- The pediatric heart network: meeting the challenges to multicenter studies in pediatric heart disease.Current opinion in pediatrics · 2015Review
- Challenges and successes of recruitment in the "angiotensin-converting enzyme inhibition in infants with single ventricle trial" of the Pediatric Heart Network.Cardiology in the young · 2013Article
- Effect of child health status on parents' allowing children to participate in pediatric research.BMC medical ethics · 2013Article
- Hypoplastic left heart syndrome: current considerations and expectations.Journal of the American College of Cardiology · 2012Review
- Clinical research careers: reports from a NHLBI pediatric heart network clinical research skills development conference.American heart journal · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 10 institutions in 2 countries.
Funding
Abstract
backgroundAngiotensin converting enzyme (ACE) inhibitors are known to improve clinical outcome and ventricular function in adults with heart failure. Infants with single-ventricle physiology show abnormalities in ventricular function as well as poor growth. The ability of an ACE inhibitor to preserve ventricular function and improve growth in these infants is unknown.
methodsThe Pediatric Heart Network designed a randomized, double-blind trial to compare outcomes in infants with single-ventricle physiology receiving enalapril or placebo. Neonates < or =45 days old were eligible. The primary outcome is weight-for-age Z-score at 14 months of age. Secondary outcomes include other measures of somatic growth, laboratory and functional measures of heart failure, developmental indices, measures of ventricular size and function, and the relationship of the renin-angiotensin-aldosterone system genotype to the response to enalapril. The incidence and spectrum of adverse events will also be compared between treatment groups.
resultsA total of 1,245 neonates were screened and 533 (43%) were eligible. The consent rate was 43%; 230 subjects were enrolled. Parental reluctance to participate was the primary reason for non-consent in 79% of the eligible nonconsenting patients. Randomized patients were older, more likely to be male, and more likely to have hypoplastic left heart syndrome than the eligible patients who did not enroll.
conclusionsThe results of this randomized trial will make an important contribution to the management of infants with single-ventricle physiology by determining whether initiation of ACE inhibition therapy in the neonatal period improves growth, clinical outcome, and ventricular function.
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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.