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Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network (ISV)

Primary Purpose

Heart Defects, Congenital, Heart Failure, Congestive

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Enalapril
Placebo
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Defects, Congenital

Eligibility Criteria

undefined - 45 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Less than or equal to 45 days of age Age greater than 1 week if born at 35 weeks gestation Single ventricle physiology Stable systemic and pulmonary blood flow Planned Glenn shunt surgery (or variant known as hemi-Fontan) Exclusion Criteria: Birth weight less than or equal to 2.5 kg if gestational age is greater than or equal to 38 weeks Birth weight less than the 10th percentile for gestational age if gestational age is 35 to 37 weeks Less than 35 weeks gestation Anatomic diagnosis of pulmonary atresia with intact ventricular septum Less than 3 days after palliative cardiac surgical procedure, if performed Aortic oxygen saturation less than 65% Current mechanical ventilatory support Current intravenous inotropic support Creatinine greater than 1.0 mg/dL Absolute neutrophil count less than 1,000 cells/mL Chromosomal or recognizable phenotypic syndrome of noncardiac congenital abnormalities associated with growth failure (e.g., Trisomy 21, Noonan's syndrome, Turner's syndrome) Prior ACE inhibitor use for greater than 7 consecutive days

Sites / Locations

  • Children's Hospital Boston
  • Columbia College of Physicians and Surgeons
  • Duke University Medical Center
  • Cincinnati Children's Hospital Medical Center
  • Children's Hospital of Philadelphia
  • Medical University of South Carolina
  • Primary Children's Hospital
  • Children's Hospital of Wisconsin
  • Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Enalapril

Placebo

Arm Description

Enalapril (angiotensin converting enzyme inhibitor)

Placebo (Ora-Plus and Ora-Sweet)

Outcomes

Primary Outcome Measures

Weight-for-age Z-score at 14 Months of Age
Weight-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of weight z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values)

Secondary Outcome Measures

Height-for-age Z-score
Height-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of height z-score at age 14 months based on longitudinal modeling (adjusted bor baseline value)
Head Circumference-for-age Z-score
Head circumference-for-age z-score at 14 months of age.In primary analysis outcome is defined as predicted mean of Head circumference z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values)
Number of Participants With Ross Heart Failure Class I
Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise.
Number of Participants With Ross Heart Failure Class I
Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise.
B-Type Natriuretic Peptide
B-Type Natriuretic Peptide (BNP) level.
B-type Natriuretic Peptide Level
B-type natriuretic peptide (BNP) level.
Neurodevelopmental Status (PDI): the Bayley Scales of Infant Development,Psychomotor Development Index Z-score
Neurodevelopmental status (PDI): the Bayley Scales of Infant Development: Psychomotor Development index z-score .
Neurodevelopmental Status(MDI): Bayley Scales of Infant Development, Mental Developmental Index Z-score
Neurodevelopmental status(MDI):Bayley Scales of infant development, Mental Developmental Index z-score .
Neurodevelopmental Status (FSII)
Functional status II (Revised) Total Score. Scale ranges up to 100.00, the higher the better. The score presents an instrument for assessing health status for children surviving long term with chronic physcial disorders.
MacArthur-Bates Inventory -Phrases Understood
MacArthur-Bates Communicative Development inventory( Words and Gestures)-Phrases Understood z-score.
MacArthur-Bates Inventory -Words Understood
MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Understood z-score.
MacArthur-Bates Inventory -Total Gestures
MacArthur-Bates Communicative Development inventory( Words and Gestures)-Total Gestures z-score.
MacArthur-Bates Inventory -Words Produced
MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Produced z-score.
Ejection Fraction (%)
Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction % is defined as the percentage of the stroke volume (i.e. difference between end-diastolic and end-systolic volumes) in a ventricle relative to end-diastolic volume.
Ejection Fraction (%)
Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction (%) is defined as percentage of stroke volume of a ventricle (i.e. the difference between end diastolic and end systolic volumes)relative to end diastolic volume.
Ventricular Mass
Two-dimensional echocardiography endpoint - Total Ventricular mass (g) per Core Laboratory assessment.
Ventricular Mass
Two-Dimensional Echocardiography endpoint-Total Ventricular mass (g) per Core Laboratory assessment. Range from 15.60 to 70.40
Ventricular Mass Z-score
Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.
Ventricular Mass Z-score
Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.
End-diastolic Volume
Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.
End-diastolic Volume
Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.
End Diastolic Volume Z-score
Two-dimensional echocardiography endpoint -total End diastolic volume z-score per Core Laboratory assessment.
End-diastolic Volume Z-score
Two-dimensional echocardiography endpoint -total end-diastolic volume z-score per Core Laboratory assessment.
Ventricular Mass to Volume Ratio
Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.
Ventricular Mass to Volume Ratio
Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.
Ventricular Filling Pressure
Ventricular filling pressure measured by catherization
Number of Participants With Moderate to Severe AV Valve Regurgitation
Number of participants with Moderate to severe AV valve regurgitation.
Number of Participants With Moderate to Severe AV Valve Regurgitation
Number of participants with moderate to severe AV valve regurgitation.

Full Information

First Posted
June 3, 2005
Last Updated
September 16, 2010
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
Pediatric Heart Network
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1. Study Identification

Unique Protocol Identification Number
NCT00113087
Brief Title
Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network
Acronym
ISV
Official Title
Trial of ACE Inhibition in Infants With Single Ventricle (A Trial Conducted by the Pediatric Heart Network)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
Pediatric Heart Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of administering an angiotensin converting enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle. The study will also compare the effect of ACE-I therapy to placebo on somatic growth and compare the effect of ACE-I therapy to placebo on signs and symptoms of heart failure, neurodevelopmental and functional status, ventricular geometry, function, and atrioventricular (AV) valve regurgitation. In addition, the study will determine the relationship between genetic polymorphisms linked to ventricular hypertrophy (enlarged heart) and the response to ACE-I therapy and compare the incidence of adverse events in subjects treated with ACE-I with those in subjects treated with placebo.
Detailed Description
BACKGROUND: Growth impairment is common in infants and children with congenital heart disease, most often in the presence of congestive heart failure and/or cyanosis. Growth failure is noted in many infants with a single ventricle who manifest both cyanosis and heart failure that commonly persist after palliative surgery. Whether this impairment is related to persistent or progressive abnormalities in cardiac structure and function is not known. ACE-Is are widely used in the treatment of infants with severe congestive heart failure to improve cardiac function and somatic growth. The ability of an ACE-I to improve somatic growth in infants with a single ventricle has not been previously studied. This study has been approved by the Institutional Review Boards/Research Ethics Boards of all participating clinical centers: Hospital for Sick Children, Toronto, Canada Children's Hospital Boston, Boston, MA Columbia College of Physicians and Surgeons, New York, NY Children's Hospital of Philadelphia, Philadelphia, PA Duke University Medical Center, Durham, NC Brody School of Medicine at East Carolina University, Greenville, NC Wake Forest Baptist Medical Center, Winston Salem, NC Medical University of South Carolina, Charleston, SC Primary Children's Medical Center, Salt Lake City, UT Children's Hospital of Wisconsin, Milwaukee, WI Cincinnati Children's Hospital Medical Center, Cincinnati, OH DESIGN NARRATIVE: This is a prospective, randomized, double-blind, placebo-controlled trial of ACE-I in infants with a single ventricle. After stratification by ventricular anatomy, neonates will be randomly assigned to receive enalapril or placebo and then followed for 14 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital, Heart Failure, Congestive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enalapril
Arm Type
Active Comparator
Arm Description
Enalapril (angiotensin converting enzyme inhibitor)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (Ora-Plus and Ora-Sweet)
Intervention Type
Drug
Intervention Name(s)
Enalapril
Intervention Description
Enalapril to target dose of .4mg/kg/day divided to twice per day (BID)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo
Primary Outcome Measure Information:
Title
Weight-for-age Z-score at 14 Months of Age
Description
Weight-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of weight z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values)
Time Frame
Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age
Secondary Outcome Measure Information:
Title
Height-for-age Z-score
Description
Height-for-age z-score at 14 months of age. In primary analysis outcome is defined as predicted mean of height z-score at age 14 months based on longitudinal modeling (adjusted bor baseline value)
Time Frame
Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age
Title
Head Circumference-for-age Z-score
Description
Head circumference-for-age z-score at 14 months of age.In primary analysis outcome is defined as predicted mean of Head circumference z-score at age 14 months based on longitudinal modeling(and adjusted for baseline values)
Time Frame
Measured at baseline, 2 weeks after starting study drug, just prior to the Glenn surgery, 7 days after restarting drug following the Glenn surgery, at 10 months of age, and at 14 months of age
Title
Number of Participants With Ross Heart Failure Class I
Description
Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise.
Time Frame
Just prior to the pre-Glenn surgery
Title
Number of Participants With Ross Heart Failure Class I
Description
Class I is defined as having no limitations or symptoms of heart failure. Classes II to IV include increasing degrees of growth failure, prolonged feeding time, tachypnea, diaphoresis, and in older children, dyspnea on exercise.
Time Frame
Measured at 14 months of age
Title
B-Type Natriuretic Peptide
Description
B-Type Natriuretic Peptide (BNP) level.
Time Frame
Measured just prior to the Glenn surgery
Title
B-type Natriuretic Peptide Level
Description
B-type natriuretic peptide (BNP) level.
Time Frame
at the time of the 14 month visit
Title
Neurodevelopmental Status (PDI): the Bayley Scales of Infant Development,Psychomotor Development Index Z-score
Description
Neurodevelopmental status (PDI): the Bayley Scales of Infant Development: Psychomotor Development index z-score .
Time Frame
at 14 months of age
Title
Neurodevelopmental Status(MDI): Bayley Scales of Infant Development, Mental Developmental Index Z-score
Description
Neurodevelopmental status(MDI):Bayley Scales of infant development, Mental Developmental Index z-score .
Time Frame
at 14 months of age
Title
Neurodevelopmental Status (FSII)
Description
Functional status II (Revised) Total Score. Scale ranges up to 100.00, the higher the better. The score presents an instrument for assessing health status for children surviving long term with chronic physcial disorders.
Time Frame
at 14 months of age
Title
MacArthur-Bates Inventory -Phrases Understood
Description
MacArthur-Bates Communicative Development inventory( Words and Gestures)-Phrases Understood z-score.
Time Frame
at 14 months of age
Title
MacArthur-Bates Inventory -Words Understood
Description
MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Understood z-score.
Time Frame
at 14 months of age
Title
MacArthur-Bates Inventory -Total Gestures
Description
MacArthur-Bates Communicative Development inventory( Words and Gestures)-Total Gestures z-score.
Time Frame
at 14 months of age
Title
MacArthur-Bates Inventory -Words Produced
Description
MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Produced z-score.
Time Frame
at 14 months of age
Title
Ejection Fraction (%)
Description
Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction % is defined as the percentage of the stroke volume (i.e. difference between end-diastolic and end-systolic volumes) in a ventricle relative to end-diastolic volume.
Time Frame
just before the Glenn surgery
Title
Ejection Fraction (%)
Description
Two-dimensional echocardiography endpoint -Total Ejection Fraction (%) per Core Laboratory assessment. Ejection Fraction (%) is defined as percentage of stroke volume of a ventricle (i.e. the difference between end diastolic and end systolic volumes)relative to end diastolic volume.
Time Frame
at 14 months of age
Title
Ventricular Mass
Description
Two-dimensional echocardiography endpoint - Total Ventricular mass (g) per Core Laboratory assessment.
Time Frame
just before the Glenn surgery
Title
Ventricular Mass
Description
Two-Dimensional Echocardiography endpoint-Total Ventricular mass (g) per Core Laboratory assessment. Range from 15.60 to 70.40
Time Frame
At 14 months of age
Title
Ventricular Mass Z-score
Description
Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.
Time Frame
just before the Glenn surgery
Title
Ventricular Mass Z-score
Description
Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.
Time Frame
at 14 months of age
Title
End-diastolic Volume
Description
Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.
Time Frame
just before the Glenn surgery
Title
End-diastolic Volume
Description
Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.
Time Frame
at 14 months of age
Title
End Diastolic Volume Z-score
Description
Two-dimensional echocardiography endpoint -total End diastolic volume z-score per Core Laboratory assessment.
Time Frame
just before the Glenn surgery
Title
End-diastolic Volume Z-score
Description
Two-dimensional echocardiography endpoint -total end-diastolic volume z-score per Core Laboratory assessment.
Time Frame
at 14 months of age
Title
Ventricular Mass to Volume Ratio
Description
Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.
Time Frame
Measured just before the Glenn surgery
Title
Ventricular Mass to Volume Ratio
Description
Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.
Time Frame
Measured at 14 months of age
Title
Ventricular Filling Pressure
Description
Ventricular filling pressure measured by catherization
Time Frame
just before the Glenn surgery
Title
Number of Participants With Moderate to Severe AV Valve Regurgitation
Description
Number of participants with Moderate to severe AV valve regurgitation.
Time Frame
just before the pre-Glenn surgery
Title
Number of Participants With Moderate to Severe AV Valve Regurgitation
Description
Number of participants with moderate to severe AV valve regurgitation.
Time Frame
at age 14 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
45 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Less than or equal to 45 days of age Age greater than 1 week if born at 35 weeks gestation Single ventricle physiology Stable systemic and pulmonary blood flow Planned Glenn shunt surgery (or variant known as hemi-Fontan) Exclusion Criteria: Birth weight less than or equal to 2.5 kg if gestational age is greater than or equal to 38 weeks Birth weight less than the 10th percentile for gestational age if gestational age is 35 to 37 weeks Less than 35 weeks gestation Anatomic diagnosis of pulmonary atresia with intact ventricular septum Less than 3 days after palliative cardiac surgical procedure, if performed Aortic oxygen saturation less than 65% Current mechanical ventilatory support Current intravenous inotropic support Creatinine greater than 1.0 mg/dL Absolute neutrophil count less than 1,000 cells/mL Chromosomal or recognizable phenotypic syndrome of noncardiac congenital abnormalities associated with growth failure (e.g., Trisomy 21, Noonan's syndrome, Turner's syndrome) Prior ACE inhibitor use for greater than 7 consecutive days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Page Anderson, MD
Organizational Affiliation
Duke University Medical Center, Durham, NC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daphne Hsu, MD
Organizational Affiliation
The Children's Hospital at Montefiore, NYC, NY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian McCrindle, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LuAnn Minich, MD
Organizational Affiliation
Primary Children's Hospital, Salt Lake City, UT
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jane Newburger, MD
Organizational Affiliation
Children's Hospital Boston, Boston, MA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Philip Saul, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lynn Sleeper, Sc.D.
Organizational Affiliation
New England Research Institute, Watertown, MA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victoria Vetter, MD
Organizational Affiliation
Children's Hospital of Philadelphia, Philadelphia, PA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Woodrow Benson, MD
Organizational Affiliation
Cincinnati Children's Medical Center, Cincinnati, OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Columbia College of Physicians and Surgeons
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26490132
Citation
Miller TA, Zak V, Shrader P, Ravishankar C, Pemberton VL, Newburger JW, Shillingford AJ, Dagincourt N, Cnota JF, Lambert LM, Sananes R, Richmond ME, Hsu DT, Miller SG, Zyblewski SC, Williams RV; Pediatric Heart Network Investigators. Growth Asymmetry, Head Circumference, and Neurodevelopmental Outcomes in Infants with Single Ventricles. J Pediatr. 2016 Jan;168:220-225.e1. doi: 10.1016/j.jpeds.2015.09.041. Epub 2015 Oct 17.
Results Reference
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PubMed Identifier
22939929
Citation
Ravishankar C, Zak V, Williams IA, Bellinger DC, Gaynor JW, Ghanayem NS, Krawczeski CD, Licht DJ, Mahony L, Newburger JW, Pemberton VL, Williams RV, Sananes R, Cook AL, Atz T, Khaikin S, Hsu DT; Pediatric Heart Network Investigators. Association of impaired linear growth and worse neurodevelopmental outcome in infants with single ventricle physiology: a report from the pediatric heart network infant single ventricle trial. J Pediatr. 2013 Feb;162(2):250-6.e2. doi: 10.1016/j.jpeds.2012.07.048. Epub 2012 Aug 30.
Results Reference
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PubMed Identifier
22939855
Citation
Cnota JF, Allen KR, Colan S, Covitz W, Graham EM, Hehir DA, Levine JC, Margossian R, McCrindle BW, Minich LL, Natarajan S, Richmond ME, Hsu DT; Pediatric Heart Network Investigators. Superior cavopulmonary anastomosis timing and outcomes in infants with single ventricle. J Thorac Cardiovasc Surg. 2013 May;145(5):1288-96. doi: 10.1016/j.jtcvs.2012.07.069. Epub 2012 Aug 28.
Results Reference
derived
PubMed Identifier
22931751
Citation
Pike NA, Pemberton V, Allen K, Jacobs JP, Hsu DT, Lewis AB, Ghanayem N, Lambert L, Crawford K, Atz T, Korsin R, Xu M, Ravishankar C, Cnota J, Pearson GD. Challenges and successes of recruitment in the "angiotensin-converting enzyme inhibition in infants with single ventricle trial" of the Pediatric Heart Network. Cardiol Young. 2013 Apr;23(2):248-57. doi: 10.1017/S1047951112000832. Epub 2012 Jul 5. Erratum In: Cardiol Young. 2013 Apr;23(2):314.
Results Reference
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PubMed Identifier
21784436
Citation
Williams RV, Zak V, Ravishankar C, Altmann K, Anderson J, Atz AM, Dunbar-Masterson C, Ghanayem N, Lambert L, Lurito K, Medoff-Cooper B, Margossian R, Pemberton VL, Russell J, Stylianou M, Hsu D; Pediatric Heart Network Investigators. Factors affecting growth in infants with single ventricle physiology: a report from the Pediatric Heart Network Infant Single Ventricle Trial. J Pediatr. 2011 Dec;159(6):1017-22.e2. doi: 10.1016/j.jpeds.2011.05.051. Epub 2011 Jul 23.
Results Reference
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PubMed Identifier
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Citation
Mital S, Chung WK, Colan SD, Sleeper LA, Manlhiot C, Arrington CB, Cnota JF, Graham EM, Mitchell ME, Goldmuntz E, Li JS, Levine JC, Lee TM, Margossian R, Hsu DT; Pediatric Heart Network Investigators. Renin-angiotensin-aldosterone genotype influences ventricular remodeling in infants with single ventricle. Circulation. 2011 May 31;123(21):2353-62. doi: 10.1161/CIRCULATIONAHA.110.004341. Epub 2011 May 16.
Results Reference
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PubMed Identifier
20625111
Citation
Hsu DT, Zak V, Mahony L, Sleeper LA, Atz AM, Levine JC, Barker PC, Ravishankar C, McCrindle BW, Williams RV, Altmann K, Ghanayem NS, Margossian R, Chung WK, Border WL, Pearson GD, Stylianou MP, Mital S; Pediatric Heart Network Investigators. Enalapril in infants with single ventricle: results of a multicenter randomized trial. Circulation. 2010 Jul 27;122(4):333-40. doi: 10.1161/CIRCULATIONAHA.109.927988. Epub 2010 Jul 12.
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PubMed Identifier
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Citation
Hsu DT, Mital S, Ravishankar C, Margossian R, Li JS, Sleeper LA, Williams RV, Levine JC, McCrindle BW, Atz AM, Servedio D, Mahony L; Pediatric Heart Network Investigators. Rationale and design of a trial of angiotensin-converting enzyme inhibition in infants with single ventricle. Am Heart J. 2009 Jan;157(1):37-45. doi: 10.1016/j.ahj.2008.08.030.
Results Reference
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Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network

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