Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01HL068270 | U.S. NIH Grant/Contract | View source | |
| U01HL068279 | U.S. NIH Grant/Contract | View source | |
| U01HL068281 | U.S. NIH Grant/Contract | View source | |
| U01HL068285 | U.S. NIH Grant/Contract | View source | |
| U01HL068288 | U.S. NIH Grant/Contract | View source | |
| U01HL068290 | U.S. NIH Grant/Contract | View source | |
| U01HL068292 | U.S. NIH Grant/Contract | View source | |
| U01HL068269 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pediatric Heart Network | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enalapril | Active Comparator | Enalapril (angiotensin converting enzyme inhibitor) |
|
| Placebo | Placebo Comparator | Placebo (Ora-Plus and Ora-Sweet) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enalapril | Drug | Enalapril to target dose of .4mg/kg/day divided to twice per day (BID) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Page Anderson, MD | Duke University Medical Center, Durham, NC | Principal Investigator |
| Daphne Hsu, MD | The Children's Hospital at Montefiore, NYC, NY | Principal Investigator |
| Brian McCrindle, MD | The Hospital for Sick Children | Principal Investigator |
| LuAnn Minich, MD | Primary Children's Hospital, Salt Lake City, UT | Principal Investigator |
| Jane Newburger, MD | Children's Hospital Boston, Boston, MA | Principal Investigator |
| J. Philip Saul, MD | Medical University of South Carolina | Principal Investigator |
| Lynn Sleeper, Sc.D. | New England Research Institute, Watertown, MA | Principal Investigator |
| Victoria Vetter, MD | Children's Hospital of Philadelphia, Philadelphia, PA | Principal Investigator |
| Woodrow Benson, MD | Cincinnati Children's Medical Center, Cincinnati, OH |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States | ||
| Columbia College of Physicians and Surgeons |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26490132 | Derived | 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. | |
| 22939929 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enalapril | ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Participants will receive placebo |
|
| 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 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. | 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 at 14 months of age |
| B-Type Natriuretic Peptide | B-Type Natriuretic Peptide (BNP) level. | Measured just prior to the Glenn surgery |
| B-type Natriuretic Peptide Level | B-type natriuretic peptide (BNP) level. | 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 . | 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 . | 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. | at 14 months of age |
| MacArthur-Bates Inventory -Phrases Understood | MacArthur-Bates Communicative Development inventory( Words and Gestures)-Phrases Understood z-score. | at 14 months of age |
| MacArthur-Bates Inventory -Words Understood | MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Understood z-score. | at 14 months of age |
| MacArthur-Bates Inventory -Total Gestures | MacArthur-Bates Communicative Development inventory( Words and Gestures)-Total Gestures z-score. | at 14 months of age |
| MacArthur-Bates Inventory -Words Produced | MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Produced z-score. | 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. | 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. | at 14 months of age |
| Ventricular Mass | Two-dimensional echocardiography endpoint - Total Ventricular mass (g) per Core Laboratory assessment. | 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 | At 14 months of age |
| Ventricular Mass Z-score | Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment. | just before the Glenn surgery |
| Ventricular Mass Z-score | Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment. | at 14 months of age |
| End-diastolic Volume | Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment. | just before the Glenn surgery |
| End-diastolic Volume | Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment. | at 14 months of age |
| End Diastolic Volume Z-score | Two-dimensional echocardiography endpoint -total End diastolic volume z-score per Core Laboratory assessment. | just before the Glenn surgery |
| End-diastolic Volume Z-score | Two-dimensional echocardiography endpoint -total end-diastolic volume z-score per Core Laboratory assessment. | at 14 months of age |
| Ventricular Mass to Volume Ratio | Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment. | 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 at 14 months of age |
| Ventricular Filling Pressure | Ventricular filling pressure measured by catherization | 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. | 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. | at age 14 months |
| New York |
| New York |
| 10032 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| 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. |
| 22939855 | Derived | 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. |
| 22931751 | Derived | 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. |
| 21784436 | Derived | 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. |
| 21576655 | Derived | 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. |
| 20625111 | Derived | 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. |
| 19081394 | Derived | 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. |
Placebo suspension
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enalapril | ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses |
| BG001 | Placebo | Placebo suspension |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | days |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | ITT, no imputation | Posted | Nov 2009 | Least Squares Mean | Standard Error | standard deviation | 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 | 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) | Posted | Least Squares Mean | Standard Error | standard deviation | 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 | 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) | ITT, no imputation | Posted | Least Squares Mean | Standard Error | standard deviation | 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 | 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. | Intention-to-treat analysis of participants measured just prior to the Glenn surgery | Posted | Number | Participants | Just prior to the pre-Glenn surgery |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intention-to-treat analysis of participants completing the final study visit (target visit window age 14 months) | Posted | Number | participants | Measured at 14 months of age |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | B-Type Natriuretic Peptide | B-Type Natriuretic Peptide (BNP) level. | ITT analysis, no imputation | Posted | Nov 2009 | Median | Inter-Quartile Range | pg/ml | Measured just prior to the Glenn surgery |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | B-type Natriuretic Peptide Level | B-type natriuretic peptide (BNP) level. | ITT, no imputation | Posted | Median | Inter-Quartile Range | pg/ml | at the time of the 14 month visit |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 . | ITT, no imputation | Posted | Nov 2009 | Mean | Standard Deviation | standard deviation | at 14 months of age |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 . | ITT, not imputation | Posted | Mean | Standard Deviation | standard deviation | at 14 months of age |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT, no imputation | Posted | Median | Inter-Quartile Range | units on a scale | at 14 months of age |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MacArthur-Bates Inventory -Phrases Understood | MacArthur-Bates Communicative Development inventory( Words and Gestures)-Phrases Understood z-score. | ITT, no imputation | Posted | Nov 2009 | Mean | Standard Deviation | standard deviation | at 14 months of age |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MacArthur-Bates Inventory -Words Understood | MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Understood z-score. | ITT, no imputation | Posted | Nov 2009 | Mean | Standard Deviation | standard deviation | at 14 months of age |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MacArthur-Bates Inventory -Total Gestures | MacArthur-Bates Communicative Development inventory( Words and Gestures)-Total Gestures z-score. | ITT, no imputation | Posted | Nov 2009 | Mean | Standard Deviation | standard deviation | at 14 months of age |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MacArthur-Bates Inventory -Words Produced | MacArthur-Bates Communicative Development inventory( Words and Gestures)-Words Produced z-score. | ITT, no imputation | Posted | Median | Inter-Quartile Range | standard deviation | at 14 months of age |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT, no imputation | Posted | Mean | Standard Deviation | percent (of end diastolic volume) | just before the Glenn surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT, no imputation | Posted | Mean | Standard Deviation | percent (of end diastolic volume) | at 14 months of age |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ventricular Mass | Two-dimensional echocardiography endpoint - Total Ventricular mass (g) per Core Laboratory assessment. | ITT, no imputation | Posted | Mean | Standard Deviation | g | just before the Glenn surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ventricular Mass | Two-Dimensional Echocardiography endpoint-Total Ventricular mass (g) per Core Laboratory assessment. Range from 15.60 to 70.40 | ITT, no imputation | Posted | Mean | Standard Deviation | g | At 14 months of age |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ventricular Mass Z-score | Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment. | ITT, no imputation | Posted | Nov 2009 | Mean | Standard Deviation | standard deviation | just before the Glenn surgery |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ventricular Mass Z-score | Two-dimensional echocardiography endpoint -Total Ventricular mass z-score per Core Laboratory assessment. | ITT, no imputation | Posted | Nov 2009 | Mean | Standard Deviation | standard deviation | at 14 months of age |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | End-diastolic Volume | Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment. | ITT, no imputation | Posted | Mean | Standard Deviation | ml | just before the Glenn surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | End-diastolic Volume | Two-Dimensional Echocardiography endpoint - Total End-diastolic volume (ml) per Core Laboratory assessment. | ITT, no imputation | Posted | Mean | Standard Deviation | ml | at 14 months of age |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | End Diastolic Volume Z-score | Two-dimensional echocardiography endpoint -total End diastolic volume z-score per Core Laboratory assessment. | ITT, no imputation | Posted | Nov 2009 | Mean | Standard Deviation | standard deviation | just before the Glenn surgery |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | End-diastolic Volume Z-score | Two-dimensional echocardiography endpoint -total end-diastolic volume z-score per Core Laboratory assessment. | ITT, no imputation | Posted | Nov 2009 | Mean | Standard Deviation | standard deviation | at 14 months of age |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ventricular Mass to Volume Ratio | Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment. | Intention-to-treat analysis of participants completing the pre-Glenn visit | Posted | Mean | Standard Deviation | g/ml | Measured just before the Glenn surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ventricular Mass to Volume Ratio | Two-Dimensional Echocardiography endpoint -Ventricular Mass to Volume ratio per Core Laboratory assessment. | Intention-to-treat analysis of participants completing the final study visit (target visit window age 14 months) | Posted | Mean | Standard Deviation | g/ml | Measured at 14 months of age |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ventricular Filling Pressure | Ventricular filling pressure measured by catherization | ITT, no imputation | Posted | Mean | Standard Deviation | mmHg | just before the Glenn surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Moderate to Severe AV Valve Regurgitation | Number of participants with Moderate to severe AV valve regurgitation. | ITT, no imputation | Posted | Number | participants | just before the pre-Glenn surgery |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Moderate to Severe AV Valve Regurgitation | Number of participants with moderate to severe AV valve regurgitation. | ITT, no imputation | Posted | Number | participants | at age 14 months |
|
|
Randomization to 14 months of age
All serious AE counts by body system are presented. The total count of affected by SAE is based on all reported SAEs.
All other AE counts by body system are presented. The total count of affected by "other AE" is based on all reported AEs other than serious.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enalapril | ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses | 88 | 115 | 77 | 115 | ||
| EG001 | Placebo | Placebo suspension | 87 | 115 | 70 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac general | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Neurology | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vascular | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| auditory/ear | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| blood/bone marrow | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| cardiac arrhythmia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| coagulation | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| constitutional symptoms | General disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| death | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| dermatology/skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| gastrointestinal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| growth and development | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| hemorrhage/bleeding | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| lymphatics | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| metabolic/laboratory | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| musculoskeletal/soft issue | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| renal/genitourinary | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| surgery/intra-operative injury | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| syndromes | Congenital, familial and genetic disorders | CTCAE (3.0) | Systematic Assessment | Adjudication by independent medical monitor for all serious adverse events |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac General | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neurology | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vascular | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| allergy/immunology | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| auditory/ear | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| blood/bone marrow | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| cardiac arrhythmia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| coagulation | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| constitutional symptoms | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| dermatology/skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| endocrine | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| gastrointestinal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hemorrhage/bleeding | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hepatobillary | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| metabolic/laboratory | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| renal/genitourinary | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| surgery/intra-operative injury | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
| |
| growth and development | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| musculoskeletal/soft tissue | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynn Sleeper | New England Research Institute | 617-972-3235 | lsleeper@neriscience.com |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D004656 | Enalapril |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Black/African-American |
|
| Asian |
|
| Other |
|
| Canada |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|