Hypertrophic CardiomyopathyCMHStressNCT02500420
Study of Hypertrophic Cardiomyopathy Under Stress Conditions. Concordance Between Two Complementary Tests: Stress MRI and Exercice Stress Echocardiography
A study testing Diagnosis examens in people with Hypertrophic Cardiomyopathy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Hypertrophic cardiomyopathy (HCM) is a primitive myocardic disease and the first of genetic cardiac diseases. The definition of HCM is an increase of the myocardial thickness of the left ventricle (LV) wall without any other causes of hypertrophy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Diagnosis examens
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Aug 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is adult (> or = 18 years) and informed.
- He's agree for a 24-month follow-up.
- The patient must be member or beneficiary of a health insurance system.
- He must have a clear diagnosis of HCM defined by a left ventricular hypertrophy in tranthoracic echocardiography (superior to 15mm or 13mm if there is a familial history) without other causes of hypertrophy (severe hypertension, aortic stenosis, amyloidosis or fabry disease, ..)
Who cannot join
- The patient is under safeguarding justice, tutorship or curatorship.
- The patient formalizes his opposition.
- It's impossible to give enlightened information.
- The patient doesn't read French.
- The patient is pregnant or breastfeeding.
- Contraindication to the realization of a MRI (defibrillator, no-MRI compatible PMK, claustrophobia,..)
Show all 9Show fewer
- Contraindication to the Persantine° injection (asthma, high degree block, ..)
- Contraindication or impossibility to realize a stress echocardiography.
- Comorbidity that can be responsible of the studied anomalies: coronaropathy, myomectomy, multicomplicated diabetes, …
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Arnaud de Villeneuve - CHRU de Montpellier
Montpellier, 34295
About this study
Hypertrophic cardiomyopathy (HCM) is a primitive myocardic disease and the first of genetic cardiac diseases. The definition of HCM is an increase of the myocardial thickness of the left ventricle (LV) wall without any other causes of hypertrophy. It's characterized by an important heterogeneity of prognosis and clinical expression going from a asymptomatic state until the devastating sudden death occurring in a young person.The diagnosis of HCM is definite by a myocardial thickness greater or equal to 15mm (or 13mm if there is a familial history).This hypertrophy is often accompanied by other abnormalities detected by echocardiography: dynamic left ventricular outflow obstruction at rest or stress, mitral regurgitation …Now, the current challenge is to determine the prognosis factors of the disease that could help to identify the patients with high risk of sudden death. Some prognosis factors are knowed and used in the calculation of a new risk score. This risk score allows to estimate the risk of sudden death at 5 years and propose depending on the result, the implantation of a defibrillator for primary prevention.The physiopathological mechanism of HCM is very complex and still misunderstood. Myocardial fibrosis could be a major mechanism of the disease evolution. Indeed, fibrosis is responsible of scar areas where ventricular tachycardia may develop. Moreover, if the fibrosis is very extensive, it can be the responsible of a systolic or diastolic dysfunction of the left ventricle leading to heart failure.Myocardial ischemia caused by a microvascular dysfunction is now recognized as an important mechanism of the disease evolution. Acute ischemic events could be a trigger of malignant arrhythmia whereas chronic ischemia leads to fibrosis.Left ventricle function is long time preserved in HCM. Segmentary hypokinesia corresponding to extensive fibrosis appears at a very advanced stage of the disease. Exercice stress echocardiography permits to detect myocardial ischemia caused by microvascular dysfunction in the HCM before the fibrosis apparition. Moreover the investigators suggest to study the deformation parameters by speckle tracking or 2D strain witness of a contractile LV dysfunction before the apparition of segmentary hypokinesia.Magnetic resonance imaging (MRI) is now recognized as the more sensible technique to identify focal myocardial fibrosis resulting in areas of late gadolinium enhancement (LGE). LGE is frequent in HCM and his extension is correlated with the severity of the hypertrophy and the risk of sudden death. Myocardial ischemia is detected by hypoperfused defects in the perfusion sequences and as LGE, is correlated with the degree of hypertrophy. Some studies using stress MRI with vasodilatator agent show inductible hypoperfused areas correlated to the degree of hypertrophy. T1 mapping is a new hopeful sequence of MRI permitting to detect the diffuse and early myocardial fibrosis. Some studies show that T1 mapping values are reduced in the areas of LGE in HCM but also in areas without LGE which reflects the presence of new fibrosis.The objective of study is to compare these two imagery techniques in order to detect ischemia and fibrosis. These techniques are usually used in the diagnosis or the monitoring of the disease. The investigators propose to realize an exercise stress echocardiography to study: the segmentary kinetic of the left ventricle and the 2D strain and a stress MRI to study the LGE, the stress perfusion and the T1 mapping.Actually the investigators consider that LGE is a risk factor of the disease (although not yet involved in the calculation of the risk of sudden death) and need to be study in each MRI realized for HCM. From the same way, the investigators suggest to follow patients to determine if the abnormalities detected by these two techniques and particularly 2D strain abnormalities, stress myocardial ischemia and T1 mapping abnormalities are prognosis factors of the disease and appear more precociously than LGE.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Diagnosis examens
- Keywords
- Hypertrophic cardiomyopathy, Stress MRI, Cardiac MRI, Stress echocardiography, T1 mapping, 2D strain
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis examensOther
- Cardiac MRI: is usually recommended in the diagnosis or in the follow-up of the disease. The MRI will respect the standard protocol: cineMRI sequences, perfusion sequences, LGE sequences at 10 minutes after gadolinium injection. The investigators will realize some additional sequences: T1 mapping before and after gadolinium injection to study the diffuse fibrosis and stress perfusion sequences after injection of a vasodilatator (Persantine°).
- Exercice stress echocardiography: is realized almost systematically in all the diagnosis of HCM and it's very informative. The investigators will research left ventricular dysfunction: in particular segmentary hypokinesia and anomalies of deformation parameters (2D Strain) and the development of a dynamic left ventricular outflow obstruction or a mitral regurgitation at exercice.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis examens | Other | * Cardiac MRI: is usually recommended in the diagnosis or in the follow-up of the disease. The MRI will respect the standard protocol: cineMRI sequences, perfusion sequences, LGE sequences at 10 minutes after gadolinium injection. The investigators will realize some additional sequences: T1 mapping before and after gadolinium injection to study the diffuse fibrosis and stress perfusion sequences after injection of a vasodilatator (Persantine°).
* Exercice stress echocardiography: is realized almost systematically in all the diagnosis of HCM and it's very informative. The investigators will research left ventricular dysfunction: in particular segmentary hypokinesia and anomalies of deformation parameters (2D Strain) and the development of a dynamic left ventricular outflow obstruction or a mitral regurgitation at exercice. Receives: Other: Diagnosis examens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with myocardial ischemia in MRI without segmental wall-motion abnormality in exercise echocardiography.
In MRI, myocardial ischemia is defined as the presence of an hypoperfused defect in the stress perfusion sequences. Presence of hypoperfused defects: YES / NO; if YES: number of segments affected among the 17-segments bullseye plot of the left ventricle (LV).In echocardiography, segmental wall-motion abnormality is recognized as significant if it affects more than 10% of the left ventricle. Presence of a significant wall-motion abnormality at exercise: YES / NO; if YES: number of LV segments affected.
Measured: Baseline
Secondary outcomes (4)
Number of patient with myocardial ischemia in MRI (same definition as defined in the primary outcome measure) and presence of late gadolinium enhancement (LGE) in MRI.
LGE is defined as the presence of an hyperintense signal in the LGE sequences at 10 minutes in at least one segment among the 17-segments bullseye plot of the LV. Presence of LGE: YES / NO; if YES: extension calculated with the number of affected segments among the 17-segments bullseye plot of the LV .
Measured: Baseline
Number of patient with myocardial ischemia in MRI (same definition as defined in the primary outcome measure) and elevation of T1 mapping before gadolinium injection or decrease of T1 mapping after gadolinium injection.
A significant increase of T1 mapping before gadolinium injection is retained for a rate higher than 1050. A significant decrease of T1 mapping after gadolinium injection is retained for a rate lower than 350.
Measured: Baseline
Number of patient with myocardial ischemia in MRI (same definition as defined in the primary outcome measure) and alteration of global and segmentary longitudinal speckle tracking or "2D Strain" at rest and exercise in echocardiography.
We retain a significant alteration of 2D strain for a rate lower than 16%. The segmental analysis is realized with the 17-segments bullseye plot of the LV.
Measured: Baseline
Time between inclusion and the occurence of an interest event like: hospitalization for cardiovascular reasons or cardiovascular death.
Measured: 24 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500420
- Sponsor's protocol ID
- 9517
- Acronym
- CMHStress
- Status last verified
- Sep 2015
- First submitted
- 23 Mar 2015
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hypertrophic Cardiomyopathy Under Stress Conditions. Concordance Between Two Complementary Tests: Stress MRI and Exercice Stress Echocardiography
- ClinicalTrials.gov ID
- NCT02500420
- Acronym / sponsor ID
- CMHStress / 9517
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Hypertrophic cardiomyopathy, Stress MRI, Cardiac MRI, Stress echocardiography, T1 mapping, 2D strain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2017 (estimated)
- First posted
- 16 Jul 2015 (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.
Hypertrophic cardiomyopathy (HCM) is a primitive myocardic disease and the first of genetic cardiac diseases. The definition of HCM is an increase of the myocardial thickness of the left ventricle (LV) wall without any other causes of hypertrophy. It's characterized by an important heterogeneity of prognosis and clinical expression going from a asymptomatic state until the devastating sudden death occurring in a young person.The diagnosis of HCM is definite by a myocardial thickness greater or equal to 15mm (or 13mm if there is a familial history).This hypertrophy is often accompanied by other abnormalities detected by echocardiography: dynamic left ventricular outflow obstruction at rest or stress, mitral regurgitation …Now, the current challenge is to determine the prognosis factors of the disease that could help to identify the patients with high risk of sudden death. Some prognosis factors are knowed and used in the calculation of a new risk score. This risk score allows to estimate the risk of sudden death at 5 years and propose depending on the result, the implantation of a defibrillator for primary prevention.The physiopathological mechanism of HCM is very complex and still misunderstood. Myocardial fibrosis could be a major mechanism of the disease evolution. Indeed, fibrosis is responsible of scar areas where ventricular tachycardia may develop. Moreover, if the fibrosis is very extensive, it can be the responsible of a systolic or diastolic dysfunction of the left ventricle leading to heart failure.Myocardial ischemia caused by a microvascular dysfunction is now recognized as an important mechanism of the disease evolution. Acute ischemic events could be a trigger of malignant arrhythmia whereas chronic ischemia leads to fibrosis.Left ventricle function is long time preserved in HCM. Segmentary hypokinesia corresponding to extensive fibrosis appears at a very advanced stage of the disease. Exercice stress echocardiography permits to detect myocardial ischemia caused by microvascular dysfunction in the HCM before the fibrosis apparition. Moreover the investigators suggest to study the deformation parameters by speckle tracking or 2D strain witness of a contractile LV dysfunction before the apparition of segmentary hypokinesia.Magnetic resonance imaging (MRI) is now recognized as the more sensible technique to identify focal myocardial fibrosis resulting in areas of late gadolinium enhancement (LGE). LGE is frequent in HCM and his extension is correlated with the severity of the hypertrophy and the risk of sudden death. Myocardial ischemia is detected by hypoperfused defects in the perfusion sequences and as LGE, is correlated with the degree of hypertrophy. Some studies using stress MRI with vasodilatator agent show inductible hypoperfused areas correlated to the degree of hypertrophy. T1 mapping is a new hopeful sequence of MRI permitting to detect the diffuse and early myocardial fibrosis. Some studies show that T1 mapping values are reduced in the areas of LGE in HCM but also in areas without LGE which reflects the presence of new fibrosis.The objective of study is to compare these two imagery techniques in order to detect ischemia and fibrosis. These techniques are usually used in the diagnosis or the monitoring of the disease. The investigators propose to realize an exercise stress echocardiography to study: the segmentary kinetic of the left ventricle and the 2D strain and a stress MRI to study the LGE, the stress perfusion and the T1 mapping.Actually the investigators consider that LGE is a risk factor of the disease (although not yet involved in the calculation of the risk of sudden death) and need to be study in each MRI realized for HCM. From the same way, the investigators suggest to follow patients to determine if the abnormalities detected by these two techniques and particularly 2D strain abnormalities, stress myocardial ischemia and T1 mapping abnormalities are prognosis factors of the disease and appear more precociously than LGE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis examens | Other | Other: Diagnosis examens* Cardiac MRI: is usually recommended in the diagnosis or in the follow-up of the disease. The MRI will respect the standard protocol: cineMRI sequences, perfusion sequences, LGE sequences at 10 minutes after gadolinium injection. The investigators will realize some additional sequences: T1 mapping before and after gadolinium injection to study the diffuse fibrosis and stress perfusion sequences after injection of a vasodilatator (Persantine°). * Exercice stress echocardiography: is realized almost systematically in all the diagnosis of HCM and it's very informative. The investigators will research left ventricular dysfunction: in particular segmentary hypokinesia and anomalies of deformation parameters (2D Strain) and the development of a dynamic left ventricular outflow obstruction or a mitral regurgitation at exercice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is adult (> or = 18 years) and informed.
- He's agree for a 24-month follow-up.
- The patient must be member or beneficiary of a health insurance system.
- He must have a clear diagnosis of HCM defined by a left ventricular hypertrophy in tranthoracic echocardiography (superior to 15mm or 13mm if there is a familial history) without other causes of hypertrophy (severe hypertension, aortic stenosis, amyloidosis or fabry disease, ..)
Key exclusion criteria (9 listed)
- The patient is under safeguarding justice, tutorship or curatorship.
- The patient formalizes his opposition.
- It's impossible to give enlightened information.
- The patient doesn't read French.
- The patient is pregnant or breastfeeding.
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 |
|---|---|---|
| Diagnosis examens* Cardiac MRI: is usually recommended in the diagnosis or in the follow-up of the disease. The MRI will respect the standard protocol: cineMRI sequences, perfusion sequences, LGE sequences at 10 minutes after gadolinium injection. The investigators will realize some additional sequences: T1 mapping before and after gadolinium injection to study the diffuse fibrosis and stress perfusion sequences after injection of a vasodilatator (Persantine°). * Exercice stress echocardiography: is realized almost systematically in all the diagnosis of HCM and it's very informative. The investigators will research left ventricular dysfunction: in particular segmentary hypokinesia and anomalies of deformation parameters (2D Strain) and the development of a dynamic left ventricular outflow obstruction or a mitral regurgitation at exercice. | Other | Diagnosis examens |
Primary outcome
Number of patients with myocardial ischemia in MRI without segmental wall-motion abnormality in exercise echocardiography.
Time frame: Baseline
In MRI, myocardial ischemia is defined as the presence of an hypoperfused defect in the stress perfusion sequences. Presence of hypoperfused defects: YES / NO; if YES: number of segments affected among the 17-segments bullseye plot of the left ventricle (LV).In echocardiography, segmental wall-motion abnormality is recognized as significant if it affects more than 10% of the left ventricle. Presence of a significant wall-motion abnormality at exercise: YES / NO; if YES: number of LV segments affected.
4 secondary outcomes
Number of patient with myocardial ischemia in MRI (same definition as defined in the primary outcome measure) and presence of late gadolinium enhancement (LGE) in MRI.
Time frame: Baseline
Number of patient with myocardial ischemia in MRI (same definition as defined in the primary outcome measure) and elevation of T1 mapping before gadolinium injection or decrease of T1 mapping after gadolinium injection.
Time frame: Baseline
Number of patient with myocardial ischemia in MRI (same definition as defined in the primary outcome measure) and alteration of global and segmentary longitudinal speckle tracking or "2D Strain" at rest and exercise in echocardiography.
Time frame: Baseline
Time between inclusion and the occurence of an interest event like: hospitalization for cardiovascular reasons or cardiovascular death.
Time frame: 24 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnosis examens in people with Hypertrophic Cardiomyopathy, run by University Hospital, Montpellier 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 4 inclusion and 9 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 3 Sep 2015. 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?
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?
Number of patients with myocardial ischemia in MRI without segmental wall-motion abnormality in exercise echocardiography. (time frame: Baseline). 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 3 Sep 2015.