Congenital Heart DiseasePhase 2NCT01668264
Imaging Assessment of Diastolic Function
A Phase 2 study testing Echocardiograph and Magnetic Resonance Imaging (MRI) in people with Congenital Heart Disease, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Diastolic function is poorly studied in children with congenital heart disease. This is mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared to echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue characterization. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Echocardiograph and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients with tetralogy of Fallot post repair, transposition of great arteries after arterial switch operation, aortic valvulopathy (aortic stenosis and aortic regurgitation), coarctation of the aorta and cardiomyopathy, who are planned to undergo a cardiac MRI will be eligible.
- Informed consent
Who cannot join
- Lack of informed consent
- Need for general anesthesia
- Similar contraindications as for a clinical MRI study apply.
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Luc Mertens, MD, (416)813-7418, luc.mertens@sickkids.ca
Luc Mertens, MD
About this study
Official title: Combined Echocardiographic and MRI Assessment of Diastolic Function in Patients With Congenital Heart Disease
Diastolic function is poorly studied in children with congenital heart disease. This is mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared to echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue characterization. The main advantage of echocardiography is a better temporal resolution which allows the study of short events like early relaxation. Overall there is a lack of studies correlating different echocardiographic and MRI parameters of heart function in pediatric populations with congenital or acquired heart diseases. This study will address specific questions on specific groups of patients that might bring more insight into chamber interaction and cardiac function. This study hypothesizes the following:
- Atrial enlargement is a marker of chronic increase in filling pressures and 3D echo might be the best method for follow-up.
- Cardiac remodeling associated with chronic loading results in changes in diastolic properties related to changes in cardiac mass and volume. This is related to changes in cardiac mechanics influencing diastolic parameters. Especially the influence on twisting and untwisting will be studied.
- Regional myocardial fibrosis and scarring may account for regional systolic and diastolic dysfunction with possible prognostic impact
- Conditions
- Congenital Heart Disease
- Being tested
- Echocardiograph, Magnetic Resonance Imaging (MRI)
- Keywords
- Pediatrics, Congenital Heart Disease, Diastolic Function, Echocardiograph, MRI
- 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.
EchocardiographProcedure or surgery
Magnetic Resonance Imaging (MRI)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Experimental | Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI. Receives: Procedure: Echocardiograph; Procedure: Magnetic Resonance Imaging (MRI) |
| Echocardiograph | Experimental | Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI. Receives: Procedure: Echocardiograph; Procedure: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Volumes
Measure right and left atrial volumes by 2D and 3D echo and correlate the different echocardiographic measurements with MRI. This will allow identifying the most accurate measurement which can be used in clinical practice.
Measured: Day 1
Secondary outcomes (2)
Assess Ventricular Volumes
Assess ventricular volumes and mass and calculate mass/volume ratio. Study the effect of ventricular remodeling on myocardial mechanics especially twisting and untwisting. Relate these changes to evaluation of diastolic function.
Measured: Day 1
Myocardial Scarring
Assess the presence of myocardial scarring in specific populations with congenital heart disease and correlate the findings with regional and global systolic and diastolic dysfunction.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Mertens, The Hospital for Sick Children
- Investigators
- Luc Mertens, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668264
- Sponsor's protocol ID
- 1000017963
- Status last verified
- Jun 2016
- First submitted
- 13 Aug 2012
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Echocardiographic and MRI Assessment of Diastolic Function in Patients With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01668264
- Acronym / sponsor ID
- 1000017963
- Conditions
- Congenital Heart Disease
- Keywords
- Pediatrics, Congenital Heart Disease, Diastolic Function, Echocardiograph, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- First posted
- 20 Aug 2012 (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.
Diastolic function is poorly studied in children with congenital heart disease. This is mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared to echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue characterization. The main advantage of echocardiography is a better temporal resolution which allows the study of short events like early relaxation. Overall there is a lack of studies correlating different echocardiographic and MRI parameters of heart function in pediatric populations with congenital or acquired heart diseases. This study will address specific questions on specific groups of patients that might bring more insight into chamber interaction and cardiac function. This study hypothesizes the following:
- Atrial enlargement is a marker of chronic increase in filling pressures and 3D echo might be the best method for follow-up.
- Cardiac remodeling associated with chronic loading results in changes in diastolic properties related to changes in cardiac mass and volume. This is related to changes in cardiac mechanics influencing diastolic parameters. Especially the influence on twisting and untwisting will be studied.
- Regional myocardial fibrosis and scarring may account for regional systolic and diastolic dysfunction with possible prognostic impact
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Experimental | Procedure: Echocardiograph, Procedure: Magnetic Resonance Imaging (MRI)Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI. |
| Echocardiograph | Experimental | Procedure: Echocardiograph, Procedure: Magnetic Resonance Imaging (MRI)Subjects with congenital heart disease will undergo an echocardiograph, as well as an MRI. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All patients with tetralogy of Fallot post repair, transposition of great arteries after arterial switch operation, aortic valvulopathy (aortic stenosis and aortic regurgitation), coarctation of the aorta and cardiomyopathy, who are planned to undergo a cardiac MRI will be eligible.
- Informed consent
Key exclusion criteria (3 listed)
- Lack of informed consent
- Need for general anesthesia
- Similar contraindications as for a clinical MRI study apply.
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 |
|---|---|---|
| Echocardiograph | Procedure or surgery | Echocardiograph, Magnetic Resonance Imaging (MRI) |
| Magnetic Resonance Imaging (MRI) | Procedure or surgery | Echocardiograph, Magnetic Resonance Imaging (MRI) |
Primary outcome
Atrial Volumes
Time frame: Day 1
Measure right and left atrial volumes by 2D and 3D echo and correlate the different echocardiographic measurements with MRI. This will allow identifying the most accurate measurement which can be used in clinical practice.
2 secondary outcomes
Assess Ventricular Volumes
Time frame: Day 1
Myocardial Scarring
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
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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.
Luc Mertens, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Echocardiograph and Magnetic Resonance Imaging (MRI) in people with Congenital Heart Disease, run by The Hospital for Sick Children at 1 site in Canada.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Jun 2016. 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luc Mertens, MD ((416)813-7418, luc.mertens@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Volumes (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2016.