Congenital Heart DiseaseNCT00848250

Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

A study testing Angiotensin Converting Enzyme Inhibitor and No ACE Inhibitor in people with Congenital Heart Disease, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease. Read more about this study

Who is it for?: Ages Up to 17 years
Conditions the study is for: Congenital Heart Disease
What is being tested?: Angiotensin Converting Enzyme Inhibitor and No ACE Inhibitor
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Sep 2008to Jul 2010
Phase: Interventional
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 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Infants or children (newborn to 17 years of age) undergoing cardiopulmonary bypass for elective surgical correction of a congenital heart defect.
Patients must be taking an ACE inhibitor prior to their operation

Who cannot join

Patients in which discontinuing ACEIs is deemed unsafe by their primary cardiologist
Any condition rendering the subjects legal guardian unable to understand the nature, scope, and possible consequences of the study.
Pregnancy as ruled out by standard of care screening procedures.
Individuals whose weight is less than 3.5 kg at the time of enrollment.
Inability to comply with the protocol. ie. Children in whom it is deemed unsafe to have the extra blood draws, and children who are thought to be noncompliant with their medications.

Trial locations and contacts

1 site in 1 country.

United States1 site

Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects

Conditions: Congenital Heart Disease
Being tested: Angiotensin Converting Enzyme Inhibitor, No ACE Inhibitor
Keywords: Cardiopulmonary Bypass, ACE inhibitor, Pediatrics
Medical subject headings: Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Angiotensin Converting Enzyme InhibitorDrug
Patients randomized to this group will continue their current dose of ACE inhibitors until surgery
No ACE InhibitorOther
Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery

Study groups in NCT00848250
Study group	Role	What they receive
ACE inhibitor	Experimental	Patients already on an ACE inhibitor will continue it until the day of surgery Receives: Drug: Angiotensin Converting Enzyme Inhibitor
No ACE inhibitor	Experimental	Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery Receives: Other: No ACE Inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

(PAI-1) Plasminogen Activator Inhibitor -1 Antigen
Measured: Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1
t-PA (Tissue-type Plasminogen Activator) Antigen
Measured: Baseline (prior to surgery) to postoperative day 1

Secondary outcomes (5)

IL-6 (Interleukin-6)
Measured: Baseline (pre-surgery) to postoperative day 1
IL-8 (Interleukin-8)
Measured: Baseline (pre-surgery) to postoperative day 1
(MAP) Mean Arterial Blood Pressure
Measured: Baseline (prior to surgery) to postoperative day 1
Postoperative Bleeding
Chest tube output at 4 and 24 hours after completion of surgery
Measured: 24 hours
Postoperative Renal Function
Acute kidney injury occurring
Measured: Baseline (prior to surgery) to postoperative day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Jul 2010

First posted20 Feb 2009 (estimated)
Study startSep 2008
Primary completionJul 2010
Study completionJul 2010

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.
Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00848250
Sponsor's protocol ID: 071078
Status last verified: Jun 2017
First submitted: 5 Feb 2009
Last updated: 26 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation

All Congenital Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects
ClinicalTrials.gov ID: NCT00848250
Acronym / sponsor ID: 071078
Conditions: Congenital Heart Disease
Keywords: Cardiopulmonary Bypass, ACE inhibitor, Pediatrics
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: Sep 2008
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 20 Feb 2009 (estimated)
Results: Posted 26 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ACE inhibitor	Experimental	Drug: Angiotensin Converting Enzyme InhibitorPatients already on an ACE inhibitor will continue it until the day of surgery
No ACE inhibitor	Experimental	Other: No ACE InhibitorPatients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery

Who may qualify

Ages: Up to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Infants or children (newborn to 17 years of age) undergoing cardiopulmonary bypass for elective surgical correction of a congenital heart defect.
Patients must be taking an ACE inhibitor prior to their operation

Key exclusion criteria (5 listed)

Patients in which discontinuing ACEIs is deemed unsafe by their primary cardiologist
Any condition rendering the subjects legal guardian unable to understand the nature, scope, and possible consequences of the study.
Pregnancy as ruled out by standard of care screening procedures.
Individuals whose weight is less than 3.5 kg at the time of enrollment.
Inability to comply with the protocol. ie. Children in whom it is deemed unsafe to have the extra blood draws, and children who are thought to be noncompliant with their medications.

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
Angiotensin Converting Enzyme InhibitorPatients randomized to this group will continue their current dose of ACE inhibitors until surgery	Drug	ACE inhibitor
No ACE InhibitorPatients randomized to this group will stop their ACE inhibitors 48 hours before surgery	Other	No ACE inhibitor

Primary outcome

(PAI-1) Plasminogen Activator Inhibitor -1 Antigen
Time frame: Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1
t-PA (Tissue-type Plasminogen Activator) Antigen
Time frame: Baseline (prior to surgery) to postoperative day 1

5 secondary outcomes

IL-6 (Interleukin-6)
Time frame: Baseline (pre-surgery) to postoperative day 1
IL-8 (Interleukin-8)
Time frame: Baseline (pre-surgery) to postoperative day 1
(MAP) Mean Arterial Blood Pressure
Time frame: Baseline (prior to surgery) to postoperative day 1
Postoperative Bleeding
Time frame: 24 hours
Postoperative Renal Function
Time frame: Baseline (prior to surgery) to postoperative day 1

Results and safety

Results posted to the registry on 26 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACE Inhibitor	11	11
No ACE Inhibitor	10	9

Primary outcome: (PAI-1) Plasminogen Activator Inhibitor -1 Antigen

Time frame: Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1. Mean (Standard Error). Unit: ng/ml

Measure	ACE Inhibitor n = 11	No ACE Inhibitor n = 9
Baseline, Pre- Cardiopulmonary bypass (CPD)	4.59 (2.36)	3.78 (0.58)
at 30 minutes on CPB	13.59 (2.8)	17.8 (2.49)
Completion of CPB	54.74 (6.63)	58.56 (0.86)
postoperative day 1 (at 8:00AM)	57.13 (12.14)	88.74 (14.02)

ACE Inhibitor vs No ACE Inhibitor: p = 0.03, ANOVA

Primary outcome: t-PA (Tissue-type Plasminogen Activator) Antigen

Time frame: Baseline (prior to surgery) to postoperative day 1. Mean (Standard Error). Unit: ng/ml

Measure	ACE Inhibitor n = 11	No ACE Inhibitor n = 9
Baseline, Pre- Cardiopulmonary bypass (CPD)	10.81 (1.0)	8.31 (0.94)
On CPB for 30 minutes	12.97 (5.43)	20.44 (6.38)
At completion of CPB	16.83 (1.84)	28.03 (3.15)
postoperative day 1 (at 8:00AM)	14.36 (3.05)	20.24 (1.82)

ACE Inhibitor vs No ACE Inhibitor: p = 0.13, ANOVA

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the start of surgery until hospital discharge, approximately 7 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACE Inhibitor	4 of 11 (36.4%)	4 of 11 (36.4%)	0 of 11
No ACE Inhibitor	2 of 9 (22.2%)	0 of 9 (0%)	0 of 9

Limitations and caveats (from the sponsor): While patients were randomized to preoperative ACE inhibition, the present study was neither blinded nor placebo-controlled. However, the dose and type of ACE inhibitor were similar between the two study groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Congenital Heart Disease

Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation

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.

Gregory A Fleming, MD principal investigator

Vanderbilt University Medical Center, Division of Pediatric Cardiology

Mias Pretorius, MBChB, MSCI study director

Vanderbilt University Medical Center, Department of Anesthesiology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Angiotensin Converting Enzyme Inhibitor and No ACE Inhibitor in people with Congenital Heart Disease, run by Vanderbilt University Medical Center at 1 site in United States.

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 2 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: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2017). 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?

(PAI-1) Plasminogen Activator Inhibitor -1 Antigen (time frame: Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1). The study lists 2 primary outcomes in all. 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 NCT00848250.

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 26 Jul 2017.