Evidence map›Paper›PMID 22331056›Full record

Trial reportPediatric cardiology2012

Impact of sildenafil on echocardiographic indices of myocardial performance after the Fontan operation.

David J Goldberg, Benjamin French, Anita L Szwast, Michael G McBride, Bradley S Marino, Nicole Mirarchi, Brian D Hanna, Gil Wernovsky, Stephen M Paridon, Jack Rychik

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pediatric cardiology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01815502 (Response to Sildenafil in Patients With Fontan Physiology, A Pressure-volume Loop Analysis), which is not on this map. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
6.0field-weighted citation impact, top 3% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT01815502 phase4completednot on this mapstarted 2013, after this paper: background citation

Response to Sildenafil in Patients With Fontan Physiology, A Pressure-volume Loop Analysis

TypeinterventionalSponsorMedical University of South CarolinaRan2013 to 2014Enrolled20ConditionsSingle Ventricle Heart Disease After Fontan SurgeryArmsCardiac catheterization
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 1 synthesis or guideline pooled it, 95 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Results of the FUEL Trial.Circulation · 2020
    Trial
  4. Trial
  5. Trial
  6. 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 · 2014
    Trial
  7. 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 · 2013
    Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Review
  13. Observational
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

David J GoldbergDivision of Cardiology, The Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA. goldbergda@email.chop.edu
Benjamin French
Anita L Szwast
Michael G McBride
Bradley S Marino
Nicole Mirarchi
Brian D Hanna
Gil Wernovsky
Stephen M Paridon
Jack Rychik
Children's Hospital of Philadelphia · USUniversity of Pennsylvania · USCincinnati Children's Hospital Medical Center · US

Funding

Training in Molecular Therapeutics for Pediatric CardiologyT32HL007915 · NHLBI · CHILDREN'S HOSP OF PHILADELPHIA · PI Robert J Levy, JOSEPH W ROSSANO · 1999 to 2026
$13.4M
NHLBI NIH HHS T32 HL007915NHLBI NIH HHS T32 HL07915
6 · The paper itself

Abstract

The objective of this study was describe the impact of sildenafil on echocardiographic measures of myocardial performance in children and young adults with a functional single-ventricle physiology late after Fontan surgery. A double-blind, placebo-controlled, crossover trial was conducted in children and young adults after the Fontan operation at a single pediatric center. Subjects were randomized to receive placebo or sildenafil (20 mg tid) for 6 weeks. After a 6-week washout period, subjects were crossed for an additional 6 weeks. Each subject underwent an echocardiogram at the start and finish of each phase. A total of 27 subjects completed study testing at a mean age of 14.9 years and a mean time from Fontan surgery of 11.3 years. After sildenafil, subjects demonstrated improvement in their myocardial performance index (MPI; -0.051; 95% CI -0.095, -0.0077; p 0.02) and in the product of the velocity time integral (VTI) of the dominant outflow tract and the heart rate (HR; 110 cm × bpm; 95% CI 7.5, 220; p = 0.04). Measures of diastolic performance, including inflow velocities, myocardial velocities, and the ratio of blood pool velocity to myocardial velocity during passive inflow, did not change. In this cohort, there were significant improvements in both the MPI and the product of the VTI × HR after 6 weeks of treatment with sildenafil. These findings suggest that sildenafil may be a useful therapy to improve or maintain ventricular performance in select patients after the Fontan operation.

Indexed as

EchocardiographyFontan ProcedureAdministration, OralAdolescentBiomarkersChildCross-Over StudiesDouble-Blind MethodFemaleHeart Defects, CongenitalHemodynamicsHumansLinear ModelsMaleOxygen ConsumptionPhosphodiesterase 5 InhibitorsBiomarkersPhosphodiesterase 5 InhibitorsPiperazinesPlacebosPurinesSildenafil CitrateSulfones

Identifiers

PMID22331056
PMCPMC4379708
OpenAlexW2074903807

What OpenQuestion holds

Textmetadata
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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.