Evidence map›Paper›PMID 21315203›Full record

Trial reportAmerican heart journal2011

Lessons learned from a pediatric clinical trial: the Pediatric Heart Network angiotensin-converting enzyme inhibition in mitral regurgitation study.

Jennifer S Li, Steven D Colan, Lynn A Sleeper, Jane W Newburger, Victoria L Pemberton, Andrew M Atz, Meryl S Cohen, Fraser Golding, Gloria L Klein, Ronald V Lacro and 3 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in American heart journal, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.8field-weighted citation impact, top 14% 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

16 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Current State of Pediatric Heart Failure.Children (Basel, Switzerland) · 2018 · on this map
    Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Comparative effectiveness of digoxin and propranolol for supraventricular tachycardia in infants.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
    Article
  15. Article
  16. Pediatric cardiovascular drug trials, lessons learned.Journal of cardiovascular pharmacology · 2011
    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

13 authors at 9 institutions in 2 countries.

Jennifer S LiDuke University Medical Center, Durham, NC, USA. jennifer.li@duke.edu
Steven D Colan
Lynn A Sleeper
Jane W Newburger
Victoria L Pemberton
Andrew M Atz
Meryl S Cohen
Fraser Golding
Gloria L Klein
Ronald V Lacro
Elizabeth Radojewski
Marc E Richmond
L Luann Minich
New England Research (United States) · USBoston Children's Museum · USHospital for Sick Children · CAChildren's Hospital of Philadelphia · USColumbia University · USDuke Medical Center · USMedical University of South Carolina · USNational Heart Lung and Blood Institute · USUniversity of Utah · 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
Randomized Trial of Nonflouroscopic Technologies in Pediatric SVT AblationU10HL109816 · NHLBI · BOSTON CHILDREN'S HOSPITAL · PI NEWBURGER, JANE W., TRIEDMAN, JOHN K · 2011 to 2015
$2.6M
The Duke-UNC-CH Pediatric Cardiology Clinical CenterU01HL068269 · NHLBI · DUKE UNIVERSITY · PI LI, JENNIFER S · 2001 to 2010
$2.6M
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 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 HL109816
6 · The paper itself

Abstract

backgroundMitral regurgitation is the most common indication for reoperation in children following repair of atrioventricular septal defect (AVSD). We hypothesized that angiotensin-converting enzyme inhibitor therapy would decrease the severity of mitral regurgitation and limit left ventricular volume overload in children following AVSD repair.

methodsThe Pediatric Heart Network designed a placebo-controlled randomized trial of enalapril in this population. The primary aim was to test the effect of enalapril on the change in left ventricular end-diastolic dimension body surface area-adjusted z score. Before the launch of the trial, a feasibility study was performed to estimate the number of patients with at least moderate mitral regurgitation following AVSD repair. TRIAL EXPERIENCE: Seventeen months after the start of the study, 349 patients were screened, 8 were trial eligible, and only 5 were enrolled. The study was subsequently terminated because of low patient accrual. Several factors led to the problems with patient accrual, including (1) the use of criteria to assess disease severity in the feasibility study that were not identical to those used in the trial, (2) failure to achieve equipoise for the study among clinicians and referring physicians, (3) reliance on methodology developed in adult populations with different disease mechanisms, and (4) absence of adequate data to define the natural history of the disease process under study. Progress in the treatment of children with cardiovascular disease will depend on the future of multicenter collaborative clinical trials. The lessons learned from this study may contribute to improvements in this research.

Indexed as

Early Termination of Clinical TrialsAngiotensin-Converting Enzyme InhibitorsChild, PreschoolEnalaprilHumansMitral Valve InsufficiencyAngiotensin-Converting Enzyme InhibitorsEnalapril

Identifiers

PMID21315203
PMCPMC3053082
OpenAlexW2060461090

What OpenQuestion holds

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Registered trials

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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.