Heart Defects, CongenitalPhase 3ISVNCT00113087
Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network
A Phase 3 study testing Enalapril in people with Heart Defects, Congenital and Heart Failure, Congestive, run by National Heart, Lung, and Blood Institute (NHLBI) at 9 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 45 days
- Conditions the study is for
- Heart Defects, Congenital, Heart Failure, Congestive
- What is being tested?
- Enalapril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Aug 2003to Jul 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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%
Show all 12Show fewer
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University Medical Center
Durham, North Carolina, 27710
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Columbia College of Physicians and Surgeons
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Primary Children's Hospital
Salt Lake City, Utah, 84113
About this study
Official title: Trial of ACE Inhibition in Infants With Single Ventricle (A Trial Conducted by the Pediatric Heart Network)
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.
Read the 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.
- Being tested
- Enalapril, Placebo
- Medical subject headings
- Heart Defects, Congenital, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnalaprilDrug
Enalapril to target dose of .4mg/kg/day divided to twice per day (BID)
PlaceboDrug
Participants will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| Enalapril | Active comparator | Enalapril (angiotensin converting enzyme inhibitor) Receives: Drug: Enalapril |
| Placebo | Placebo comparator | Placebo (Ora-Plus and Ora-Sweet) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 outcomes (28)
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)
Measured: 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
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)
Measured: 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
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.
Measured: Just prior to the pre-Glenn surgery
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.
Measured: Measured at 14 months of age
B-Type Natriuretic Peptide
B-Type Natriuretic Peptide (BNP) level.
Measured: Measured just prior to the Glenn surgery
B-type Natriuretic Peptide Level
B-type natriuretic peptide (BNP) level.
Measured: at the time of the 14 month visit
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 .
Measured: at 14 months of age
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 .
Measured: at 14 months of age
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.
Measured: at 14 months of age
MacArthur-Bates Inventory -Phrases Understood
MacArthur-Bates Communicative Development inventory( Words and Gestures)-Phrases Understood z-score.
Measured: at 14 months of age
MacArthur-Bates Inventory -Words Understood
MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Understood z-score.
Measured: at 14 months of age
MacArthur-Bates Inventory -Total Gestures
MacArthur-Bates Communicative Development inventory( Words and Gestures)-Total Gestures z-score.
Measured: at 14 months of age
MacArthur-Bates Inventory -Words Produced
MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Produced z-score.
Measured: at 14 months of age
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.
Measured: just before the Glenn surgery
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.
Measured: at 14 months of age
Ventricular Mass
Two-dimensional echocardiography endpoint - Total Ventricular mass (g) per Core Laboratory assessment.
Measured: just before the Glenn surgery
Ventricular Mass
Two-Dimensional Echocardiography endpoint-Total Ventricular mass (g) per Core Laboratory assessment. Range from 15.60 to 70.40
Measured: At 14 months of age
Ventricular Mass Z-score
Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.
Measured: just before the Glenn surgery
Ventricular Mass Z-score
Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment.
Measured: at 14 months of age
End-diastolic Volume
Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.
Measured: just before the Glenn surgery
End-diastolic Volume
Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment.
Measured: at 14 months of age
End Diastolic Volume Z-score
Two-dimensional echocardiography endpoint -total End diastolic volume z-score per Core Laboratory assessment.
Measured: just before the Glenn surgery
End-diastolic Volume Z-score
Two-dimensional echocardiography endpoint -total end-diastolic volume z-score per Core Laboratory assessment.
Measured: at 14 months of age
Ventricular Mass to Volume Ratio
Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.
Measured: Measured just before the Glenn surgery
Ventricular Mass to Volume Ratio
Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment.
Measured: Measured at 14 months of age
Ventricular Filling Pressure
Ventricular filling pressure measured by catherization
Measured: just before the Glenn surgery
Number of Participants With Moderate to Severe AV Valve Regurgitation
Number of participants with Moderate to severe AV valve regurgitation.
Measured: just before the pre-Glenn surgery
Number of Participants With Moderate to Severe AV Valve Regurgitation
Number of participants with moderate to severe AV valve regurgitation.
Measured: at age 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2005 (estimated)
- Study startAug 2003
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Pediatric Heart Network
- Investigators
- Page Anderson, MD, Principal investigator, Duke University Medical Center, Durham, NCDaphne Hsu, MD, Principal investigator, The Children's Hospital at Montefiore, NYC, NYBrian McCrindle, MD, Principal investigator, The Hospital for Sick ChildrenLuAnn Minich, MD, Principal investigator, Primary Children's Hospital, Salt Lake City, UTJane Newburger, MD, Principal investigator, Children's Hospital Boston, Boston, MAJ. Philip Saul, MD, Principal investigator, Medical University of South CarolinaLynn Sleeper, Sc.D., Principal investigator, New England Research Institute, Watertown, MAVictoria Vetter, MD, Principal investigator, Children's Hospital of Philadelphia, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113087
- Sponsor's protocol ID
- 177
- Other IDs
- U01HL068270, U01HL068279, U01HL068281, U01HL068285, U01HL068288, U01HL068290, U01HL068292, U01HL068269
- Acronym
- ISV
- Status last verified
- Sep 2009
- First submitted
- 3 Jun 2005
- Last updated
- 28 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26490132Ravishankar 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.
PubMed 22939929Cnota 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.
PubMed 22939855Pike 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.
PubMed 22931751Williams 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.
PubMed 21784436Mital 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.
PubMed 21576655Hsu 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.
PubMed 20625111Hsu 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.
PubMed 19081394
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of ACE Inhibition in Infants With Single Ventricle (A Trial Conducted by the Pediatric Heart Network)
- ClinicalTrials.gov ID
- NCT00113087
- Acronym / sponsor ID
- ISV / 177
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Pediatric Heart Network
- Study start
- Aug 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Jun 2005 (estimated)
- Results
- Posted 16 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enalapril | Active comparator | Drug: EnalaprilEnalapril (angiotensin converting enzyme inhibitor) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (Ora-Plus and Ora-Sweet) |
Who may qualify
- Ages
- Up to 45 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnalaprilEnalapril to target dose of .4mg/kg/day divided to twice per day (BID) | Drug | Enalapril |
| PlaceboParticipants will receive placebo | Drug | Placebo |
Primary outcome
Weight-for-age Z-score at 14 Months of Age
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
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)
28 secondary outcomes
Height-for-age Z-score
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
Head Circumference-for-age Z-score
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
Number of Participants With Ross Heart Failure Class I
Time frame: Just prior to the pre-Glenn surgery
Number of Participants With Ross Heart Failure Class I
Time frame: Measured at 14 months of age
B-Type Natriuretic Peptide
Time frame: Measured just prior to the Glenn surgery
B-type Natriuretic Peptide Level
Time frame: at the time of the 14 month visit
Neurodevelopmental Status (PDI): the Bayley Scales of Infant Development,Psychomotor Development Index Z-score
Time frame: at 14 months of age
Neurodevelopmental Status(MDI): Bayley Scales of Infant Development, Mental Developmental Index Z-score
Time frame: at 14 months of age
Neurodevelopmental Status (FSII)
Time frame: at 14 months of age
MacArthur-Bates Inventory -Phrases Understood
Time frame: at 14 months of age
MacArthur-Bates Inventory -Words Understood
Time frame: at 14 months of age
MacArthur-Bates Inventory -Total Gestures
Time frame: at 14 months of age
MacArthur-Bates Inventory -Words Produced
Time frame: at 14 months of age
Ejection Fraction (%)
Time frame: just before the Glenn surgery
Ejection Fraction (%)
Time frame: at 14 months of age
Ventricular Mass
Time frame: just before the Glenn surgery
Ventricular Mass
Time frame: At 14 months of age
Ventricular Mass Z-score
Time frame: just before the Glenn surgery
Ventricular Mass Z-score
Time frame: at 14 months of age
End-diastolic Volume
Time frame: just before the Glenn surgery
End-diastolic Volume
Time frame: at 14 months of age
End Diastolic Volume Z-score
Time frame: just before the Glenn surgery
End-diastolic Volume Z-score
Time frame: at 14 months of age
Ventricular Mass to Volume Ratio
Time frame: Measured just before the Glenn surgery
Ventricular Mass to Volume Ratio
Time frame: Measured at 14 months of age
Ventricular Filling Pressure
Time frame: just before the Glenn surgery
Number of Participants With Moderate to Severe AV Valve Regurgitation
Time frame: just before the pre-Glenn surgery
Number of Participants With Moderate to Severe AV Valve Regurgitation
Time frame: at age 14 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26490132Miller 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.
- Derived from this study: PubMed 22939929Ravishankar 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.
- Derived from this study: PubMed 22939855Cnota 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.
- Derived from this study: PubMed 22931751Pike 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.
- Derived from this study: PubMed 21784436Williams 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.
- Derived from this study: PubMed 21576655Mital 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.
- Derived from this study: PubMed 20625111Hsu 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.
- Derived from this study: PubMed 19081394Hsu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Page Anderson, MD principal investigator
Duke University Medical Center, Durham, NC
Daphne Hsu, MD principal investigator
The Children's Hospital at Montefiore, NYC, NY
Brian McCrindle, MD principal investigator
The Hospital for Sick Children
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enalapril in people with Heart Defects, Congenital and Heart Failure, Congestive, run by National Heart, Lung, and Blood Institute (NHLBI) at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight-for-age Z-score at 14 Months of Age (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00113087, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2010.