Dilated CardiomyopathyNCT02018835
Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study.
A study testing MRI and cardiac echography transthoracic in people with Dilated Cardiomyopathy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Detecting abnormalities in the left ventricular mechanical and hemodynamic response to the stress of exercise may offer early diagnostic indicators in patients suffering from valvular disease such as mitral regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- MRI and cardiac echography transthoracic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2013to 28 Oct 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Autonomous ADULT patient,
- patient Marfan:
- under their usual treatment(processing) (including ß blocking)
- diagnosis confirmed by the molecular biology (transfer(transformation) of the gene FBN1)
- Asymptomatic or Dilation of the aorta = 40 mm on the ascending aorta on an echocardiography or an imaging in cups(cuttings) dating less than 6 months.
- PATIENT Aortic bicuspid :
Show all 21Show fewer
- Diagnosis confirmed by cardiac echography and/or imaging in cups(cuttings)
- Asymptomatic or Dilation of the aorta = 40 mm on the ascending aorta, and absence of valvulopathy aortic significant (IA of rank I in II, absence of significant RA), on the echocardiography or the imaging in cups(cuttings) dating less than 6 months.
- patients Insufficiency mitral organic moderated in severe asymptomatic:
- SOR > 30 mm2, on an echocardiography or an imaging in cups(cuttings) dating less than 6 months
- Absence of ischemic or functional cause
- Patient recovering from a functional evaluation by echography of effort
- patients Insufficiency mitral organic severe surgical
- SOR > 40 mm2, on an echocardiography or an imaging in cups(cuttings) dating less than 6 months
- Absence of ischemic or functional cause
- Status functional: stage(stadium) II of the NYHA
- Patient recovering from a functional evaluation by echography of effort
- Volunteer healthy :
- affiliated to the Social Security
- having given its agreement by signed consent
- not presenting contraindication to the realization of a MRI
Who cannot join
- Patient claustrophobic,
- patient refusing the protocol or the examination
Trial locations and contacts
1 site in 1 country.
About this study
Detecting abnormalities in the left ventricular mechanical and hemodynamic response to the stress of exercise may offer early diagnostic indicators in patients suffering from valvular disease such as mitral regurgitation. Ultrasound-based imaging methods have been gaining importance in providing prognosis among those patients. However, decreased signal to noise ratio in the images and increased motion-related artifacts during exercise stress echocardiography have been reported, with a lack of reproducibility of results and a the limitation of its availability only in reference centers. In our laboratory, we are able to perform supine bicycle exercise MRI (1.5 T) using the Lode ergometer mounted on the far end of the patient table, previously described in healthy volunteers.
The first aim of our study is to demonstrate the safety and the feasibility of our MRI protocol in selected patients with asymptomatic severe organic mitral regurgitation, to assess left ventricular volumes and function, and regurgitant volume in comparison to exercise cardiac echography.
Read more
Besides, few recent studies sustain the relevance of novel markers of central aortic function (compliance, distensibility and pulse wave velocity) assessed by noninvasive MRI to explore vascular aging. In monogenic connective tissue diseases, altered arterial stiffness is the premature signature of the disease in asymptomatic patients. Noninvasive evaluation of aortic stiffness would be useful for risk assessment and preventive follow-up strategies in young asymptomatic relatives of subjects with aortic inherited diseases, such as syndromic and non-syndromic familial forms of thoracic aortic aneurysm and /or dissection. Furthermore, this technique should be able to evaluate the effect of drugs on aortic stiffness change in trials, before and after drug therapy, more relevant than the classic change in aortic diameter measurement.
The second aim of our study is 1) to provide the sensibility of our MRI protocol to estimate local and regional heterogeneity in aortic functional parameters (distensibility, compliance and PWV) 2) to evaluate the predictive value of these regional aortic parameters assessed by MRI to diagnose and to stratify the aortopathy related to presymptomatic Marfan patients and to bicuspid aortic valve in young adults, in comparison to carotids-femoral pulse wave velocity estimation by applanation tonometry.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- MRI, cardiac echography transthoracic
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
cardiac echography transthoracicDevice
| Study group | Role | What they receive |
|---|---|---|
| patients of an insufficiency organic severe surgical mitrale | Other | Not described Receives: Device: MRI; Device: cardiac echography transthoracic |
| insufficiency organic mitrale moderated in severe asymptomatic | Other | Not described Receives: Device: MRI; Device: cardiac echography transthoracic |
| patients of an aortic bicuspidie | Other | Not described Receives: Device: MRI; Device: cardiac echography transthoracic |
| patients of a syndrome of Marfan | Other | Not described Receives: Device: MRI; Device: cardiac echography transthoracic |
| Healthy volunteers | Other | Not described Receives: Device: MRI; Device: cardiac echography transthoracic |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood samples
to estimate local and regional heterogeneity in aortic functional parameters
Measured: 24 MONTHS
Secondary outcomes (1)
aortic function
MRI - magnetic resonance imaging
Measured: 24 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study start5 Dec 2013
- Primary completion30 Jan 2020
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique Hopitaux De Marseillealexis jacquier, Principal investigator, AP HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018835
- Sponsor's protocol ID
- 2012-A01093-40
- Other IDs
- 2012-28
- Status last verified
- Nov 2022
- First submitted
- 26 Nov 2012
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study.
- ClinicalTrials.gov ID
- NCT02018835
- Acronym / sponsor ID
- 2012-A01093-40
- Conditions
- Dilated Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 5 Dec 2013 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 23 Dec 2013 (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.
Detecting abnormalities in the left ventricular mechanical and hemodynamic response to the stress of exercise may offer early diagnostic indicators in patients suffering from valvular disease such as mitral regurgitation. Ultrasound-based imaging methods have been gaining importance in providing prognosis among those patients. However, decreased signal to noise ratio in the images and increased motion-related artifacts during exercise stress echocardiography have been reported, with a lack of reproducibility of results and a the limitation of its availability only in reference centers. In our laboratory, we are able to perform supine bicycle exercise MRI (1.5 T) using the Lode ergometer mounted on the far end of the patient table, previously described in healthy volunteers.
The first aim of our study is to demonstrate the safety and the feasibility of our MRI protocol in selected patients with asymptomatic severe organic mitral regurgitation, to assess left ventricular volumes and function, and regurgitant volume in comparison to exercise cardiac echography.
Besides, few recent studies sustain the relevance of novel markers of central aortic function (compliance, distensibility and pulse wave velocity) assessed by noninvasive MRI to explore vascular aging. In monogenic connective tissue diseases, altered arterial stiffness is the premature signature of the disease in asymptomatic patients. Noninvasive evaluation of aortic stiffness would be useful for risk assessment and preventive follow-up strategies in young asymptomatic relatives of subjects with aortic inherited diseases, such as syndromic and non-syndromic familial forms of thoracic aortic aneurysm and /or dissection. Furthermore, this technique should be able to evaluate the effect of drugs on aortic stiffness change in trials, before and after drug therapy, more relevant than the classic change in aortic diameter measurement.
The second aim of our study is 1) to provide the sensibility of our MRI protocol to estimate local and regional heterogeneity in aortic functional parameters (distensibility, compliance and PWV) 2) to evaluate the predictive value of these regional aortic parameters assessed by MRI to diagnose and to stratify the aortopathy related to presymptomatic Marfan patients and to bicuspid aortic valve in young adults, in comparison to carotids-femoral pulse wave velocity estimation by applanation tonometry.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| patients of an insufficiency organic severe surgical mitrale | Other | Device: MRI, Device: cardiac echography transthoracic |
| insufficiency organic mitrale moderated in severe asymptomatic | Other | Device: MRI, Device: cardiac echography transthoracic |
| patients of an aortic bicuspidie | Other | Device: MRI, Device: cardiac echography transthoracic |
| patients of a syndrome of Marfan | Other | Device: MRI, Device: cardiac echography transthoracic |
| Healthy volunteers | Other | Device: MRI, Device: cardiac echography transthoracic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Autonomous ADULT patient,
- under their usual treatment(processing) (including ß blocking)
- diagnosis confirmed by the molecular biology (transfer(transformation) of the gene FBN1)
- Asymptomatic or Dilation of the aorta = 40 mm on the ascending aorta on an echocardiography or an imaging in cups(cuttings) dating less than 6 months.
- Diagnosis confirmed by cardiac echography and/or imaging in cups(cuttings)
Key exclusion criteria (2 listed)
- Patient claustrophobic,
- patient refusing the protocol or the examination
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 |
|---|---|---|
| MRI | Device | Healthy volunteers, insufficiency organic mitrale moderated in severe asymptomatic, patients of a syndrome of Marfan, patients of an aortic bicuspidie, patients of an insufficiency organic severe surgical mitrale |
| cardiac echography transthoracic | Device | Healthy volunteers, insufficiency organic mitrale moderated in severe asymptomatic, patients of a syndrome of Marfan, patients of an aortic bicuspidie, patients of an insufficiency organic severe surgical mitrale |
Primary outcome
blood samples
Time frame: 24 MONTHS
to estimate local and regional heterogeneity in aortic functional parameters
1 secondary outcome
aortic function
Time frame: 24 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
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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.
BERNARD BELAIGUES study director
Assistance Publique Hopitaux De Marseille
alexis jacquier principal investigator
AP HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and cardiac echography transthoracic in people with Dilated Cardiomyopathy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 21 inclusion and 2 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 14 Nov 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
blood samples (time frame: 24 MONTHS). 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 14 Nov 2022.