Evidence map›Paper›PMID 20625111›Full record

Trial reportCirculation2010

Enalapril in infants with single ventricle: results of a multicenter randomized trial.

Daphne T Hsu, Victor Zak, Lynn Mahony, Lynn A Sleeper, Andrew M Atz, Jami C Levine, Piers C Barker, Chitra Ravishankar, Brian W McCrindle, Richard V Williams and 9 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Circulation, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 123 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
123citing papers in PubMed, 2 pooled it
12.0field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

123 citing papers in PubMed, 2 syntheses or guidelines pooled it, 291 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. 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
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Angiotensin-converting enzyme inhibition alters the inflammatory and fibrinolytic response to cardiopulmonary bypass in children.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2011
    Trial
  18. Trial
  19. Trial
  20. Article

63 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 1 institution in 1 country.

Daphne T HsuDivision of Pediatric Cardiology, Children's Hospital at Montefiore, 3415 Bainbridge Ave., Bronx, NY 10457, USA. dhsu@montefiore.org
Victor Zak
Lynn Mahony
Lynn A Sleeper
Andrew M Atz
Jami C Levine
Piers C Barker
Chitra Ravishankar
Brian W McCrindle
Richard V Williams
Karen Altmann
Nancy S Ghanayem
Renee Margossian
Wendy K Chung
William L Border
Gail D Pearson
Mario P Stylianou
Seema Mital
Pediatric Heart Network Investigators
The University of Texas Southwestern Medical Center · US

Funding

Pediatric Heart network DCCU10HL068270 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI MILLER, JULIE ELAINE, TRACHTENBERG, FELICIA LYNN · 2011 to 2016
$44.9M
Ventricular Volumes and Varability (VVV)U01HL068270 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI SLEEPER, LYNN A · 2001 to 2010
$40.3M
Pediatric Heart Network: Follow-up of the Single Ventricle Reconstruction TrialU01HL068290 · NHLBI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI LAI, WYMAN W · 2001 to 2010
$4.1M
Pediatric Heart Disease Network: CHOP MembershipU01HL068279 · NHLBI · CHILDREN'S HOSP OF PHILADELPHIA · PI VETTER, VICTORIA L · 2001 to 2010
$3.7M
Randomized Therapeutic Trials in Pediatric Heart DiseaseU01HL068285 · NHLBI · CHILDREN'S HOSPITAL BOSTON · PI NEWBURGER, JANE W. · 2001 to 2010
$3.4M
Randomized Clinical Trials for Pediatric Heart DiseaseU01HL068281 · NHLBI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI SAUL, J PHILIP · 2001 to 2010
$3.2M
Clinical and genomic responses to remote ischemic preconditioningU01HL068288 · NHLBI · HOSPITAL FOR SICK CHLDRN (TORONTO) · PI MCCRINDLE, BRIAN W · 2001 to 2010
$3.0M
Intermountain Pediatric Heart Disease Research CenterU01HL068292 · NHLBI · UNIVERSITY OF UTAH · PI MINICH, L. LUANN · 2001 to 2010
$2.7M
The Duke-UNC-CH Pediatric Cardiology Clinical CenterU01HL068269 · NHLBI · DUKE UNIVERSITY · PI LI, JENNIFER S · 2001 to 2010
$2.6M
Pediatric Heart Network Medical University of South CarolinaU10HL109778 · NHLBI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI ATZ, ANDREW M, GRAHAM, ERIC M. · 2011 to 2015
$2.2M
Preoperative Therapy for Prevention of Postoperative Low Cardiac Output SyndromeU01HL085057 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI BENSON, DUDLEY WOODROW (WOODY) · 2006 to 2010
$1.5M
NHLBI NIH HHS HL068269NHLBI NIH HHS HL068270NHLBI NIH HHS HL068279NHLBI NIH HHS HL068281NHLBI NIH HHS HL068285NHLBI NIH HHS HL068288NHLBI NIH HHS HL068290NHLBI NIH HHS HL068292NHLBI NIH HHS HL085057NHLBI NIH HHS U01 HL068269NHLBI NIH HHS U01 HL068270NHLBI NIH HHS U01 HL068279NHLBI NIH HHS U01 HL068281NHLBI NIH HHS U01 HL068285NHLBI NIH HHS U01 HL068288NHLBI NIH HHS U01 HL068290NHLBI NIH HHS U01 HL068292NHLBI NIH HHS U01 HL085057NHLBI NIH HHS U10 HL068270NHLBI NIH HHS U10 HL109778
6 · The paper itself

Abstract

backgroundAngiotensin-converting enzyme inhibitor therapy improves clinical outcome and ventricular function in adults with heart failure. Infants with single-ventricle physiology have poor growth and are at risk for abnormalities in ventricular systolic and diastolic function. The ability of angiotensin-converting enzyme inhibitor therapy to preserve ventricular function and improve somatic growth and outcomes in these infants is unknown. METHODS AND

resultsThe Pediatric Heart Network conducted a double-blind trial involving 230 infants with single-ventricle physiology randomized to receive enalapril (target dose 0.4 mg . kg(-1) . d(-1)) or placebo who were followed up until 14 months of age. The primary end point was weight-for-age z score at 14 months. The primary analysis was intention to treat. A total of 185 infants completed the study. There were 24 and 21 withdrawals or deaths in the enalapril and placebo groups, respectively (P=0.74). Weight-for-age z score was not different between the enalapril and placebo groups (mean+/-SE -0.62+/-0.13 versus -0.42+/-0.13, P=0.28). There were no significant group differences in height-for-age z score, Ross heart failure class, brain natriuretic peptide concentration, Bayley scores of infant development, or ventricular ejection fraction. The incidence of death or transplantation was 13% and did not differ between groups. Serious adverse events occurred in 88 patients in the enalapril group and 87 in the placebo group.

conclusionsAdministration of enalapril to infants with single-ventricle physiology in the first year of life did not improve somatic growth, ventricular function, or heart failure severity. The results of this randomized trial do not support the routine use of enalapril in this population.

Indexed as

AldosteroneAngiotensin-Converting Enzyme InhibitorsAntihypertensive AgentsDouble-Blind MethodEnalaprilEndothelium, VascularGlomerular Filtration RateHeart FailureHeart VentriclesHumansInfantStroke VolumeAldosteroneAngiotensin-Converting Enzyme InhibitorsAntihypertensive AgentsEnalapril

Identifiers

PMID20625111
PMCPMC3692364
OpenAlexW2024501954

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.