Heart Defects, CongenitalPhase 3AceiMRNCT00113698
Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation
A Phase 3 study testing Enalapril in people with Heart Defects, Congenital and Heart Septal Defects, Ventricular, run by University of Utah at 7 sites in 2 countries.
Trial summary
This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition (ACE-I) therapy for the treatment of mitral regurgitation (MR). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Heart Defects, Congenital, Heart Septal Defects, Ventricular, Heart Failure, Congestive
- What is being tested?
- Enalapril
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2004to Jan 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children less than 18 years of age and at least 6 months post AVSD repair or reoperation
- At least moderate MR
- Asymptomatic or minimally symptomatic, defined by Ross Heart Failure Class I or II
- Atrioventricular synchrony (paced or intrinsic)
Who cannot join
- Tetrology of Fallot, total or partial anomalous venous connection
- More than trivial MS or outflow obstruction
- Other sources of LV volume overload
- Hypertrophic obstructive cardiomyopathy
- Significant residual coarctation
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Duke University Medical Center
Durham, North Carolina, 27710
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, 84132
About this study
Official title: Trial of ACE Inhibition in Children With Mitral Regurgitation After Repair of AVSD
This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition (ACE-I) therapy for the treatment of mitral regurgitation (MR).
Read the detailed description
BACKGROUND:
MR causes volume overload and hemodynamic burden on the left ventricle. Initial compensatory mechanisms may fail, leading to increased severity. Patients who have had repair of an atrioventricular septal defect (AVSD) are selected for this study as they have a relatively high incidence of moderate MR and their regurgitant orifice is mobile and dynamic, contributing to the likelihood that they might respond to medical therapy.
DESIGN NARRATIVE:
This is a randomized, double-blind, placebo-controlled trial of ACE-I therapy in children less than 18 years of age with at least moderate MR who are at least 6 months postoperative from repair of an AVSD. A non-randomized Observational Phase enrolled 181 children who were less than 6 months postoperative from repair of an AVSD, who were then evaluated at 6 months for trial eligibility.
- Being tested
- Enalapril, Placebo
- Medical subject headings
- Heart Defects, Congenital, Heart Septal Defects, Ventricular, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnalaprilDrug
Up-titration period is to reach the highest tolerated dose up to a maximum of 0.4 mg/kg/day
PlaceboOther
Placebo An inert preparation with similar appearance and taste to the drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Other: Placebo |
| 2 | Active comparator | Ace inhibition (enalapril) Receives: Drug: Enalapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the effect of ACE-I therapy with that of placebo on left ventricular size
Measured: Measured after six months of therapy
Secondary outcomes (3)
Comparison of the effect of ACE-I therapy with placebo on MR severity, left ventricular geometry, hemodynamics, and signs and symptoms of congestive heart failure
Measured: 6 months on study drug
Evaluation of the early natural history of MR in the six months after repair of an AVSD
Measured: 6 months on study drug
Comparison of the incidence of adverse events occurring in subjects treated with ACE-I therapy to that in subjects receiving placebo (measured after six months of therapy)
Measured: 6 months on safety drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2005 (estimated)
- Study startDec 2004
- Primary completionNov 2005
- Study completionJan 2006
Why it stopped: lower than expected enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 University of UtahThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network
- Responsible party
- Principal investigator, Lois LuAnn Minich, University of Utah
- Investigators
- LuAnn Minich, MD, Principal investigator, Primary Children's Hospital, Salt Lake City, UT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113698
- Sponsor's protocol ID
- 185
- Other IDs
- U01HL068269, U01HL068270, U01HL068279, U01HL068281, U01HL068285, U01HL068288, U01HL068290, U01HL068292
- Acronym
- AceiMR
- Status last verified
- Mar 2014
- First submitted
- 9 Jun 2005
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li JS, Colan SD, Sleeper LA, Newburger JW, Pemberton VL, Atz AM, Cohen MS, Golding F, Klein GL, Lacro RV, Radojewski E, Richmond ME, Minich LL. Lessons learned from a pediatric clinical trial: the Pediatric Heart Network angiotensin-converting enzyme inhibition in mitral regurgitation study. Am Heart J. 2011 Feb;161(2):233-40. doi: 10.1016/j.ahj.2010.10.030.
PubMed 21315203Atz AM, Hawkins JA, Lu M, Cohen MS, Colan SD, Jaggers J, Lacro RV, McCrindle BW, Margossian R, Mosca RS, Sleeper LA, Minich LL; Pediatric Heart Network Investigators. Surgical management of complete atrioventricular septal defect: associations with surgical technique, age, and trisomy 21. J Thorac Cardiovasc Surg. 2011 Jun;141(6):1371-9. doi: 10.1016/j.jtcvs.2010.08.093. Epub 2010 Dec 15.
PubMed 21163497
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of ACE Inhibition in Children With Mitral Regurgitation After Repair of AVSD
- ClinicalTrials.gov ID
- NCT00113698
- Acronym / sponsor ID
- AceiMR / 185
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lower than expected enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network
- Study start
- Dec 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 10 Jun 2005 (estimated)
- Results
- Not posted in the source record
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 angiotensin converting enzyme inhibition (ACE-I) therapy for the treatment of mitral regurgitation (MR).
Detailed description
BACKGROUND:
MR causes volume overload and hemodynamic burden on the left ventricle. Initial compensatory mechanisms may fail, leading to increased severity. Patients who have had repair of an atrioventricular septal defect (AVSD) are selected for this study as they have a relatively high incidence of moderate MR and their regurgitant orifice is mobile and dynamic, contributing to the likelihood that they might respond to medical therapy.
DESIGN NARRATIVE:
This is a randomized, double-blind, placebo-controlled trial of ACE-I therapy in children less than 18 years of age with at least moderate MR who are at least 6 months postoperative from repair of an AVSD. A non-randomized Observational Phase enrolled 181 children who were less than 6 months postoperative from repair of an AVSD, who were then evaluated at 6 months for trial eligibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: Placebo |
| 2 | Active comparator | Drug: EnalaprilAce inhibition (enalapril) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children less than 18 years of age and at least 6 months post AVSD repair or reoperation
- At least moderate MR
- Asymptomatic or minimally symptomatic, defined by Ross Heart Failure Class I or II
- Atrioventricular synchrony (paced or intrinsic)
Key exclusion criteria (5 listed)
- Tetrology of Fallot, total or partial anomalous venous connection
- More than trivial MS or outflow obstruction
- Other sources of LV volume overload
- Hypertrophic obstructive cardiomyopathy
- Significant residual coarctation
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 |
|---|---|---|
| EnalaprilUp-titration period is to reach the highest tolerated dose up to a maximum of 0.4 mg/kg/day | Drug | 2 |
| PlaceboPlacebo An inert preparation with similar appearance and taste to the drug | Other | 1 |
Primary outcome
Comparison of the effect of ACE-I therapy with that of placebo on left ventricular size
Time frame: Measured after six months of therapy
3 secondary outcomes
Comparison of the effect of ACE-I therapy with placebo on MR severity, left ventricular geometry, hemodynamics, and signs and symptoms of congestive heart failure
Time frame: 6 months on study drug
Evaluation of the early natural history of MR in the six months after repair of an AVSD
Time frame: 6 months on study drug
Comparison of the incidence of adverse events occurring in subjects treated with ACE-I therapy to that in subjects receiving placebo (measured after six months of therapy)
Time frame: 6 months on safety drug
Results and safety
The study was stopped early (reason given: lower than expected enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
- Derived from this study: PubMed 21315203Li JS, Colan SD, Sleeper LA, Newburger JW, Pemberton VL, Atz AM, Cohen MS, Golding F, Klein GL, Lacro RV, Radojewski E, Richmond ME, Minich LL. Lessons learned from a pediatric clinical trial: the Pediatric Heart Network angiotensin-converting enzyme inhibition in mitral regurgitation study. Am Heart J. 2011 Feb;161(2):233-40. doi: 10.1016/j.ahj.2010.10.030.
- Derived from this study: PubMed 21163497Atz AM, Hawkins JA, Lu M, Cohen MS, Colan SD, Jaggers J, Lacro RV, McCrindle BW, Margossian R, Mosca RS, Sleeper LA, Minich LL; Pediatric Heart Network Investigators. Surgical management of complete atrioventricular septal defect: associations with surgical technique, age, and trisomy 21. J Thorac Cardiovasc Surg. 2011 Jun;141(6):1371-9. doi: 10.1016/j.jtcvs.2010.08.093. Epub 2010 Dec 15.
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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.
LuAnn Minich, MD principal investigator
Primary Children's Hospital, Salt Lake City, UT
7 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 Septal Defects, Ventricular, run by University of Utah at 7 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study was stopped early (reason given: lower than expected enrollment). Results are not available in the source record.
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?
Comparison of the effect of ACE-I therapy with that of placebo on left ventricular size (time frame: Measured after six months of therapy). 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 NCT00113698, which also lists 2 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 13 Mar 2014.