Trial · NCT00113087
Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network
NCT00113087, Phase 3, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2010-09-16
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ConductScience Library. Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network. Trials, record NCT00113087. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00113087
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network
- NCT number
- NCT00113087
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 230 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Heart Defects, Congenital, Heart Failure, Congestive
- Interventions
- Enalapril, Placebo
- First posted
- 2005-06-06
- Last updated
- 2010-09-28
- Results first posted
- 2010-09-16
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Weight-for-age Z-score at 14 Months of Age | 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) |
| Secondary | Height-for-age Z-score | 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 | 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) |
| Secondary | Head Circumference-for-age Z-score | 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 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) |
| Secondary | Number of Participants With Ross Heart Failure Class I | Just prior to the pre-Glenn surgery | 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. |
| Secondary | Number of Participants With Ross Heart Failure Class I | Measured at 14 months of age | 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. |
| Secondary | B-Type Natriuretic Peptide | Measured just prior to the Glenn surgery | B-Type Natriuretic Peptide (BNP) level. |
| Secondary | B-type Natriuretic Peptide Level | at the time of the 14 month visit | B-type natriuretic peptide (BNP) level. |
| Secondary | Neurodevelopmental Status (PDI): the Bayley Scales of Infant Development,Psychomotor Development Index Z-score | at 14 months of age | Neurodevelopmental status (PDI): the Bayley Scales of Infant Development: Psychomotor Development index z-score . |
| Secondary | Neurodevelopmental Status(MDI): Bayley Scales of Infant Development, Mental Developmental Index Z-score | at 14 months of age | Neurodevelopmental status(MDI):Bayley Scales of infant development, Mental Developmental Index z-score . |
| Secondary | Neurodevelopmental Status (FSII) | at 14 months of age | 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. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Weight-for-age Z-score at 14 Months of Age | 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 | ITT, no imputation | standard deviation | LEAST_SQUARES_MEAN |
| SECONDARY | Height-for-age Z-score | 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 | standard deviation | LEAST_SQUARES_MEAN | |
| SECONDARY | Head Circumference-for-age Z-score | 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 | ITT, no imputation | standard deviation | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Ross Heart Failure Class I | Just prior to the pre-Glenn surgery | Intention-to-treat analysis of participants measured just prior to the Glenn surgery | Participants | NUMBER |
| SECONDARY | Number of Participants With Ross Heart Failure Class I | Measured at 14 months of age | Intention-to-treat analysis of participants completing the final study visit (target visit window age 14 months) | participants | NUMBER |
| SECONDARY | B-Type Natriuretic Peptide | Measured just prior to the Glenn surgery | ITT analysis, no imputation | pg/ml | MEDIAN |
| SECONDARY | B-type Natriuretic Peptide Level | at the time of the 14 month visit | ITT, no imputation | pg/ml | MEDIAN |
| SECONDARY | Neurodevelopmental Status (PDI): the Bayley Scales of Infant Development,Psychomotor Development Index Z-score | at 14 months of age | ITT, no imputation | standard deviation | MEAN |
| SECONDARY | Neurodevelopmental Status(MDI): Bayley Scales of Infant Development, Mental Developmental Index Z-score | at 14 months of age | ITT, not imputation | standard deviation | MEAN |
| SECONDARY | Neurodevelopmental Status (FSII) | at 14 months of age | ITT, no imputation | units on a scale | MEDIAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Weight-for-age Z-score at 14 Months of Age | Enalapril | -0.62 | Standard Error 0.13 | standard deviation | |
| Weight-for-age Z-score at 14 Months of Age | Placebo | -0.42 | Standard Error 0.13 | standard deviation | |
| Height-for-age Z-score | Enalapril | -1.00 | Standard Error 0.13 | standard deviation | |
| Height-for-age Z-score | Placebo | -0.86 | Standard Error 0.13 | standard deviation | |
| Head Circumference-for-age Z-score | Enalapril | -0.55 | Standard Error 0.17 | standard deviation | |
| Head Circumference-for-age Z-score | Placebo | 0.09 | Standard Error 0.17 | standard deviation | |
| Number of Participants With Ross Heart Failure Class I | Enalapril | 53 | Participants | ||
| Number of Participants With Ross Heart Failure Class I | Placebo | 56 | Participants | ||
| Number of Participants With Ross Heart Failure Class I | Enalapril | 72 | participants | ||
| Number of Participants With Ross Heart Failure Class I | Placebo | 77 | participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Enalapril | 115 | |
| Overall Study | STARTED | Placebo | 115 | |
| Overall Study | COMPLETED | Enalapril | 91 | |
| Overall Study | COMPLETED | Placebo | 94 | |
| Overall Study | NOT COMPLETED | Enalapril | 24 | |
| Overall Study | NOT COMPLETED | Placebo | 21 |
Source ClinicalTrials.gov
Adverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cardiac General | Cardiac disorders | Enalapril | 18 | 115 | 23 |
| other | Cardiac General | Cardiac disorders | Placebo | 12 | 115 | 15 |
| other | Neurology | Nervous system disorders | Enalapril | 5 | 115 | 6 |
| other | Neurology | Nervous system disorders | Placebo | 6 | 115 | 9 |
| other | Pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | Enalapril | 20 | 115 | 28 |
| other | Pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders | Placebo | 22 | 115 | 25 |
| other | Vascular | Vascular disorders | Enalapril | 7 | 115 | 7 |
| other | Vascular | Vascular disorders | Placebo | 5 | 115 | 5 |
| other | infection | Infections and infestations | Enalapril | 38 | 115 | 66 |
| other | infection | Infections and infestations | Placebo | 33 | 115 | 64 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enalapril | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Enalapril | 77 | 115 |
| Total, other adverse events | Placebo | 70 | 115 |
| Total, serious adverse events | Enalapril | 88 | 115 |
| Total, serious adverse events | Placebo | 87 | 115 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants8
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01HL068269 | Pediatric Heart Network North Carolina Consortium | LI, JENNIFER S | DUKE UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 | NIH RePORTER |
| U01HL068270 | Pediatric Heart Network: Data Coordinating Center | SLEEPER, LYNN A | NEW ENGLAND RESEARCH INSTITUTES, INC. | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 | NIH RePORTER |
| U01HL068279 | ADHD (Attention Deficit Hyperactivity Disorder) after Surgery for Congenital Hear | VETTER, VICTORIA L | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 | NIH RePORTER |
| U01HL068281 | Randomized Clinical Trials for Pediatric Heart Disease | SAUL, J PHILIP | MEDICAL UNIVERSITY OF SOUTH CAROLINA | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 | NIH RePORTER |
| U01HL068285 | Randomized, placebo-controlled, double-blind trial of T3 in infant heart surgery | NEWBURGER, JANE W. | BOSTON CHILDREN'S HOSPITAL | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 | NIH RePORTER |
| U01HL068288 | Clinical and genomic responses to remote ischemic preconditioning | MCCRINDLE, BRIAN W | HOSPITAL FOR SICK CHLDRN (TORONTO) | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 | NIH RePORTER |
| U01HL068290 | Pediatric Heart Network: Follow-up of the Single Ventricle Reconstruction Trial | LAI, WYMAN W | COLUMBIA UNIVERSITY HEALTH SCIENCES | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 | NIH RePORTER |
| U01HL068292 | Intermountain Pediatric Heart Disease Research Center | MINICH, L. LUANN | UNIVERSITY OF UTAH | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 | NIH RePORTER |
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Enalapril vs Placebo: Number of Participants With Moderate to Severe AV Valve Regurgitation | Trial comparisons |
| Enalapril vs Placebo: Number of Participants With Ross Heart Failure Class I | Trial comparisons |
| Enalapril vs Placebo: Number of Participants With Ross Heart Failure Class I | Trial comparisons |
| Enalapril vs Placebo: Number of Participants With Moderate to Severe AV Valve Regurgitation | Trial comparisons |
| Enalapril vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00113087
GET https://conductscience.org/api/trials/v1/NCT00113087/registered?page=2