Trial reportCirculation2011
Impact of oral sildenafil on exercise performance in children and young adults after the fontan operation: a randomized, double-blind, placebo-controlled, crossover trial.
Trial report in Circulation, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 97 papers, 4 of them syntheses that pooled it.
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.
The Sildenafil After Fontan Operation Study
Response to Sildenafil in Patients With Fontan Physiology, A Pressure-volume Loop Analysis
Who cites it
97 citing papers in PubMed, 4 syntheses or guidelines pooled it, 292 citations in OpenAlex.
- Pharmacology Management in Improving Exercise Capacity of Patients with Fontan Circulation: A Systematic Review and Meta-analysis.Current cardiology reviews · 2022Pooled it
- Pulmonary vasodilator therapy after the Fontan procedure: a meta-analysis.Heart failure reviews · 2021Pooled it
- The Long-Term Management of Children and Adults with a Fontan Circulation: A Systematic Review and Survey of Current Practice in Australia and New Zealand.Pediatric cardiology · 2017Pooled it
- Is chronic inhibition of phosphodiesterase type 5 cardioprotective and safe? A meta-analysis of randomized controlled trials.BMC medicine · 2014Pooled it
- The Effect of Udenafil on Heart Rate and Blood Pressure in Adolescents With the Fontan Circulation.The American journal of cardiology · 2024Trial
- The Fontan Udenafil Exercise Longitudinal Trial: Subgroup Analysis.Pediatric cardiology · 2023Trial
- Carvedilol Does Not Improve Exercise Performance in Fontan Patients: Results of a Crossover Trial.Pediatric cardiology · 2021Trial
- A Randomized, Controlled Pharmacokinetic and Pharmacodynamics Trial of Ambrisentan After Fontan Surgery.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2020Trial
- Results of the FUEL Trial.Circulation · 2020Trial
- Results of a phase I/II multi-center investigation of udenafil in adolescents after fontan palliation.American heart journal · 2017Trial
- Tricuspid annular plane systolic excursion correlates with exercise capacity in a cohort of patients with hypoplastic left heart syndrome after Fontan operation.Echocardiography (Mount Kisco, N.Y.) · 2016Trial
- 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
- Pharmacokinetics of intravenous sildenafil in children with palliated single ventricle heart defects: effect of elevated hepatic pressures.Cardiology in the young · 2016Trial
- Effect of Sildenafil on Pressure-Volume Loop Measures of Ventricular Function in Fontan Patients.Pediatric cardiology · 2016Trial
- Factors associated with serum B-type natriuretic peptide in infants with single ventricles.Pediatric cardiology · 2014Trial
- Sildenafil exposure and hemodynamic effect after Fontan surgery.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2014Trial
- Effect of inhaled iloprost on the exercise function of Fontan patients: a demonstration of concept.International journal of cardiology · 2013Trial
- Sildenafil exposure and hemodynamic effect after stage II single-ventricle surgery.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2013Trial
- The effect of bosentan on exercise capacity in Fontan patients; rationale and design for the TEMPO study.BMC cardiovascular disorders · 2013Trial
- Sildenafil and ventriculo-arterial coupling in Fontan-palliated patients: a noninvasive echocardiographic assessment.Pediatric cardiology · 2013Trial
37 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
9 authors at 1 institution in 1 country.
Funding
Abstract
backgroundChildren and young adults with single-ventricle physiology have abnormal exercise capacity after the Fontan operation. A medication capable of decreasing pulmonary vascular resistance should allow improved cardiac filling and improved exercise capacity. METHODS AND
resultsThis study was a double-blind, placebo-controlled, crossover trial conducted in children and young adults after Fontan. Subjects were randomized to receive placebo or sildenafil (20 mg three times daily) for 6 weeks. After a 6-week washout, subjects crossed over for an additional 6 weeks. Each subject underwent an exercise stress test at the start and finish of each phase. After taking sildenafil, subjects had a significantly decreased respiratory rate and decreased minute ventilation at peak exercise. At the anaerobic threshold, subjects had significantly decreased ventilatory equivalents of carbon dioxide. There was no change in oxygen consumption during peak exercise, although there was a suggestion of improved oxygen consumption at the anaerobic threshold. Improvement at the anaerobic threshold was limited to the subgroup with single left or mixed ventricular morphology and to the subgroup with baseline serum brain natriuretic peptide levels ≥100 pg/mL.
conclusionsIn this cohort, sildenafil significantly improved ventilatory efficiency during peak and submaximal exercise. There was also a suggestion of improved oxygen consumption at the anaerobic threshold in 2 subgroups. These findings suggest that sildenafil may be an important agent for improving exercise performance in children and young adults with single-ventricle physiology after the Fontan operation. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00507819.
Indexed as
Identifiers
What OpenQuestion holds
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.