Document Detail


Enalapril in infants with single ventricle: results of a multicenter randomized trial.
MedLine Citation:
PMID:  20625111     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Angiotensin-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 RESULTS: The 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.
CONCLUSIONS: Administration 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.
Authors:
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; Karen Altmann; Nancy S Ghanayem; Renee Margossian; Wendy K Chung; William L Border; Gail D Pearson; Mario P Stylianou; Seema Mital;
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, Non-P.H.S.     Date:  2010-07-12
Journal Detail:
Title:  Circulation     Volume:  122     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-07-27     Completed Date:  2010-09-13     Revised Date:  2014-06-26    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  333-40     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00113087
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MeSH Terms
Descriptor/Qualifier:
Aldosterone / blood
Angiotensin-Converting Enzyme Inhibitors / therapeutic use*
Antihypertensive Agents / adverse effects,  therapeutic use
Double-Blind Method
Enalapril / adverse effects,  therapeutic use*
Endothelium, Vascular / physiopathology
Glomerular Filtration Rate / physiology
Heart Failure / epidemiology*
Heart Ventricles / abnormalities*
Humans
Infant
Stroke Volume
Grant Support
ID/Acronym/Agency:
HL068269/HL/NHLBI NIH HHS; HL068270/HL/NHLBI NIH HHS; HL068279/HL/NHLBI NIH HHS; HL068281/HL/NHLBI NIH HHS; HL068285/HL/NHLBI NIH HHS; HL068288/HL/NHLBI NIH HHS; HL068290/HL/NHLBI NIH HHS; HL068292/HL/NHLBI NIH HHS; HL085057/HL/NHLBI NIH HHS; U01 HL068270-09/HL/NHLBI NIH HHS; U01 HL068290/HL/NHLBI NIH HHS; U01 HL068290-09/HL/NHLBI NIH HHS; U10 HL109778/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Angiotensin-Converting Enzyme Inhibitors; 0/Antihypertensive Agents; 4964P6T9RB/Aldosterone; 69PN84IO1A/Enalapril
Investigator
Investigator/Affiliation:
Gail Pearson / ; Victoria Pemberton / ; Mario Stylianou / ; Marsha Mathis / ; Lynn Mahony / ; Lynn Sleeper / ; Steven Colan / ; Lisa Virzi / ; Lisa Wruck / ; Victor Zak / ; David F Teitel / ; Leslie Kalish / ; Patty Connell / ; Jane W Newburger / ; Roger Breitbart / ; Jami Levine / ; Ellen McGrath / ; Carolyn Dunbar-Masterson / ; Daphne Hsu / ; William Hellenbrand / ; Ashwin Prakash / ; Seema Mital / ; Darlene Servedio / ; Victoria L Vetter / ; Chitra Ravishankar / ; Sarah Tabbutt / ; Meryl Cohen / ; Katherine Lee / ; Marisa Nolan / ; Stephanie Piacentino / ; Michelle Toms / ; D Woodrow Benson / ; Catherine Dent Krawczeski / ; Lois Bogenschutz / ; Teresa Barnard / ; Steven Schwartz / ; David Nelson / ; Page A W Anderson / ; Jennifer Li / ; Wesley Covitz / ; Kari Crawford / ; Michael Hines / ; James Jaggers / ; Theodore Koutlas / ; Charlie Sang / ; Lori Jo Sutton / ; Mingfen Xu / ; J Philip Saul / ; Andrew Atz / ; Girish Shirali / ; Eric M Graham / ; Teresa Atz / ; LuAnn Minich / ; John A Hawkins / ; Richard V Williams / ; Linda M Lambert / ; Marian E Shearrow / ; Brian McCrindle / ; Elizabeth Radojewski / ; Nancy Slater / ; Svetlana Khaikin / ; Susan McIntyre / ; Nancy Ghanayem / ; Kathy Mussatto / ; Michele Frommelt / ; Lisa Young-Borkowski / ; Albert Rocchini / ; Laurie Rodgers-Augustyniak / ; Steven Colan / ; Renee Margossian / ; Wendy Chung / ; Liyong Deng / ; Patricia Lanzano / ; Michael Artman / ; Judith Massicot-Fisher / ; Timothy Feltes / ; Julie Johnson / ; Thomas Klitzner / ; Jeffrey Krischer / ; G Paul Matherne / ; John Kugler / ; Rae-Ellen Kavey / ; David J Driscoll / ; Mark Galantowicz / ; Sally A Hunsberger / ; Thomas J Knight / ; Holly Taylor / ; Catherine L Webb /
Comments/Corrections
Comment In:
Circulation. 2011 Mar 15;123(10):e374   [PMID:  21403120 ]
Circulation. 2011 Mar 15;123(10):e373   [PMID:  21403119 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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