Hypertrophic CardiomyopathyCMHFLUXNCT04439942
4D-flow MRI to Assess Left Ventricular Obstruction in Hypertrophic Cardiomyopathy
An observational study of Hypertrophic Cardiomyopathy and Obstruction, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Hypertrophic cardiomyopathy (HCM) is a frequent cardiac pathology with an estimated prevalence of 1/500 in France. The main risk factor for sudden death in this pathology is the presence and extent of left ventricular obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Obstruction, Echocardiography
- What is being tested?
- cardiac magnetic resonance imaging (MRI)
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2020to 1 Jun 2023
- Phase
- Observational
- 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
Study population: All patients with Hypertrophic cardiomyopathy will undergo Doppler-echocardiography followed promptly (within the same hour) by a complete cardiac MRI with the addition of a 4D Flow sequence (does not require the injection of a contrast agent and does not prolong the duration of the examination).
Who may be able to join
- Age ≥ 18 years old
- Presence of a Hypertrophic cardiomyopathy (HCM)
- Affiliation to a social security program
- Ability of the subject to understand and express opposition
Who cannot join
- Major obesity (> 140 kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70cm,
- Age < 18,
- Person under guardianship or curators,
- Pregnant woman,
- Allergy to gadolinium chelates,
- Claustrophobia,
- Any contraindications to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 4D Flow Cardiac MRI Velocity Mapping in Patients With Hypertrophic Cardiomyopathy: Assessment of the Severity of the Left Ventricular Obstruction and Comparison With Echocardiography
Hypertrophic cardiomyopathy (HCM) is a frequent cardiac pathology with an estimated prevalence of 1/500 in France. The main risk factor for sudden death in this pathology is the presence and extent of left ventricular obstruction. To date, the only method allowing a reliable assessment of the extent of left ventricular obstruction is Doppler echocardiography. All patients with HCM should undergo cardiac magnetic resonance imaging (MRI) to confirm the diagnosis and for the detection of fibrosis, but conventional sequences cannot reliably assess the obstruction. 4D-flow MRI provides a complete coverage of an entire volume with the ability to simultaneously measure the outputs of all vessels within that volume in a single sequence and might be able to quantify left ventricular obstruction.
The main objective of this study is to compare the quantification of left ventricular obstruction in hypertrophic cardiomyopathy by Doppler echocardiography and 4D flow MRI.
- Conditions
- Hypertrophic Cardiomyopathy, Obstruction, Echocardiography
- Being tested
- cardiac magnetic resonance imaging (MRI)
- Keywords
- Hypertrophic Cardiomyopathy, 4D-flow magnetic resonance imaging, Obstruction, maximal gradient, echocardiography
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac magnetic resonance imaging (MRI)Other
Cardiac MRI is a mandatory examination for Hypertrophic cardiomyopathy patients as it provides important information about the presence of fibrosis which is also directly associated with sudden cardiac death.
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by echocardiography.
Correlation coefficient assessment between the maximum gradient obtained by 4D flow
Measured: day 1
Secondary outcomes (1)
Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast
Correlation coefficient assessment between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast
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 posted19 Jun 2020
- Study start17 Jun 2020
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
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 Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédric Renard, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439942
- Sponsor's protocol ID
- PI2020_843_0047
- Acronym
- CMHFLUX
- Status last verified
- Aug 2023
- First submitted
- 18 Jun 2020
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4D Flow Cardiac MRI Velocity Mapping in Patients With Hypertrophic Cardiomyopathy: Assessment of the Severity of the Left Ventricular Obstruction and Comparison With Echocardiography
- ClinicalTrials.gov ID
- NCT04439942
- Acronym / sponsor ID
- CMHFLUX / PI2020_843_0047
- Conditions
- Hypertrophic Cardiomyopathy, Obstruction, Echocardiography
- Keywords
- Hypertrophic Cardiomyopathy, 4D-flow magnetic resonance imaging, Obstruction, maximal gradient, echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 19 Jun 2020 (actual)
- 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 frequent cardiac pathology with an estimated prevalence of 1/500 in France. The main risk factor for sudden death in this pathology is the presence and extent of left ventricular obstruction. To date, the only method allowing a reliable assessment of the extent of left ventricular obstruction is Doppler echocardiography. All patients with HCM should undergo cardiac magnetic resonance imaging (MRI) to confirm the diagnosis and for the detection of fibrosis, but conventional sequences cannot reliably assess the obstruction. 4D-flow MRI provides a complete coverage of an entire volume with the ability to simultaneously measure the outputs of all vessels within that volume in a single sequence and might be able to quantify left ventricular obstruction.
The main objective of this study is to compare the quantification of left ventricular obstruction in hypertrophic cardiomyopathy by Doppler echocardiography and 4D flow MRI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with Hypertrophic cardiomyopathy will undergo Doppler-echocardiography followed promptly (within the same hour) by a complete cardiac MRI with the addition of a 4D Flow sequence (does not require the injection of a contrast agent and does not prolong the duration of the examination).
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Presence of a Hypertrophic cardiomyopathy (HCM)
- Affiliation to a social security program
- Ability of the subject to understand and express opposition
Key exclusion criteria (7 listed)
- Major obesity (> 140 kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70cm,
- Age < 18,
- Person under guardianship or curators,
- Pregnant woman,
- Allergy to gadolinium chelates,
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 |
|---|---|---|
| cardiac magnetic resonance imaging (MRI)Cardiac MRI is a mandatory examination for Hypertrophic cardiomyopathy patients as it provides important information about the presence of fibrosis which is also directly associated with sudden cardiac death. | Other | – |
Primary outcome
Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by echocardiography.
Time frame: day 1
Correlation coefficient assessment between the maximum gradient obtained by 4D flow
1 secondary outcome
Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast
Time frame: day 1
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 23 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Cédric Renard, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy and Obstruction, run by Centre Hospitalier Universitaire, Amiens 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 7 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 23 Aug 2023. 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?
Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by echocardiography. (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 23 Aug 2023.