Diastolic DysfunctionDIAMERNCT05438030
Diastolic Function Assessment With Cardiac Magnetic Resonance Imaging
A study testing Cardiac MRI scan and Echocardiogram scan in people with Diastolic Dysfunction, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Cardiac magnetic resonance (CMR) imaging is excellent at assessing the contractility of the heart muscle. However, relatively little is known about CMR's ability to assess the relaxation (diastolic function) of the heart between heart beats, where echocardiography remains the gold standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diastolic Dysfunction
- What is being tested?
- Cardiac MRI scan and Echocardiogram scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2022to 1 Jun 2024
- 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
- Cohort 1: patients with preserved systolic function, grade 2 or more diastolic dysfunction on echocardiography, a raised BNP, and a diagnosis typically causing HFPEF (e.g., hypertrophic cardiomyopathy, severe aortic stenosis, or cardiac amyloidosis).
- Cohort 2: patients without grade 2 or more diastolic dysfunction on echocardiography.
Who cannot join
- Contraindications to CMR or echocardiographic scanning - for safety.
- Contraindications to gadolinium contrast agents - for safety.
- Severe claustrophobia - extra CMR scanning may prove too difficult.
- Pregnancy - likely to be undergoing progressive physiological changes in the conduct of the study which may invalid assumptions about repeat scanning.
- The ability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hammersmith Hospital
London, W12 0HS
James P Howard, PhD, +44 (0)20 7594 5735, james.howard1@imperial.ac.uk
About this study
Cardiac magnetic resonance (CMR) imaging is excellent at assessing the contractility of the heart muscle. However, relatively little is known about CMR's ability to assess the relaxation (diastolic function) of the heart between heart beats, where echocardiography remains the gold standard. This is important because in 30% of heart failure patients the overwhelming problem is diastolic dysfunction, and so they often need both tests.
The investigators wish to investigate how to best make measurements using CMR to identify those with impaired diastolic function, in the context of the current gold standard test (echocardiography).
Read the detailed description
37 participants will be recruited, comprising a mix of patients with diastolic heart dysfunction and health controls.
The diseased cohort will comprise patients with preserved systolic function and known raised B-type natriuretic peptide levels (BNP, a blood test indicating raised pressures in the heart) from cardiology clinics who are undergoing a clinical CMR scan.
The healthy controls will comprise patients also undergoing MRI scans, but who are strongly expected not to have heart diastolic disease - for example, patients undergoing MRI scans for family screening but displaying no symptoms or other abnormal tests. BNP blood testing will not be necessary for the healthy control arm.
If a participant in the health control arm is found to have diastolic dysfunction, they will be eligible to cross over to the diseased group, after discussing their results with their physician. At this point, a BNP level will be checked if the patient is happy to continue in the study. The criteria for crossover this will be Grade 2 or greater diastolic dysfunction as per the British Society of Echocardiography Diastolic Dysfunction guidelines. If the BNP level is not raised, despite meeting imaging criteria for diastolic dysfunction, the patient will not be eligible for the full analysis and the second visit will not be performed.
Patients in the diseased cohort will represent a range of pathologies that typically cause HFPEF (heart failure with preserved ejection fraction), including hypertrophic cardiomyopathy, aortic stenosis, and cardiac amyloidosis.
On the same day as their clinical CMR scan, participants will undergo a focused research echocardiogram which will include quantification of left atrium size, trans-mitral Doppler, tissue Doppler imaging and global longitudinal strain (GLS). All measurements will be performed in both left lateral decubitus positioning (typical for echocardiography) and supine positioning (typical for CMR).
Participants will then undergo their clinical CMR scan.
After their CMR scan, patients will then undergo repeat focused echocardiography.
When patients return for their clinical follow-up, they will undergo a repeat focused echocardiogram and 15-minute research CMR scan.
This design allows the agreement between each CMR and echocardiographic measure of diastolic function to be assessed. More importantly, this agreement can be described in the context of:
- Changes in diastolic function parameters due to patient positioning
- Changes in diastolic function parameters during a scan, e.g. due to the patient relaxing
- Each modality's test re-test reproducibility over two timescales (less than 1 hour versus several weeks).
- Conditions
- Diastolic Dysfunction
- Being tested
- Cardiac MRI scan, Echocardiogram scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRI scanDiagnostic test
Undertaken at the radiology department at Hammersmith Hospital. The scan will be performed by the MRI radiographers, under the supervision of a consultant radiologist or cardiologist.
Echocardiogram scanDiagnostic test
Undertaken at the Peart Rose research unit, by a British Society of Echocardiography accredited sonographer.
| Study group | Role | What they receive |
|---|---|---|
| Paired cardiac MRI and echocardiographic measurements | Experimental | Not described Receives: Diagnostic Test: Cardiac MRI scan; Diagnostic Test: Echocardiogram scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy using e:E'
The accuracy rate using the ratio (dimensionless) of early mitral valve inflow (centimetres per second) to the mitral valve peak relaxation velocity (centimeters per second), measured using echocardiography and cardiac MRI.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Sep 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438030
- Sponsor's protocol ID
- 21HH7048
- Acronym
- DIAMER
- Status last verified
- Mar 2023
- First submitted
- 21 Jun 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diastolic Function Assessment With Cardiac Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05438030
- Acronym / sponsor ID
- DIAMER / 21HH7048
- Conditions
- Diastolic Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 29 Jun 2022 (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.
Cardiac magnetic resonance (CMR) imaging is excellent at assessing the contractility of the heart muscle. However, relatively little is known about CMR's ability to assess the relaxation (diastolic function) of the heart between heart beats, where echocardiography remains the gold standard. This is important because in 30% of heart failure patients the overwhelming problem is diastolic dysfunction, and so they often need both tests.
The investigators wish to investigate how to best make measurements using CMR to identify those with impaired diastolic function, in the context of the current gold standard test (echocardiography).
Detailed description
37 participants will be recruited, comprising a mix of patients with diastolic heart dysfunction and health controls.
The diseased cohort will comprise patients with preserved systolic function and known raised B-type natriuretic peptide levels (BNP, a blood test indicating raised pressures in the heart) from cardiology clinics who are undergoing a clinical CMR scan.
The healthy controls will comprise patients also undergoing MRI scans, but who are strongly expected not to have heart diastolic disease - for example, patients undergoing MRI scans for family screening but displaying no symptoms or other abnormal tests. BNP blood testing will not be necessary for the healthy control arm.
If a participant in the health control arm is found to have diastolic dysfunction, they will be eligible to cross over to the diseased group, after discussing their results with their physician. At this point, a BNP level will be checked if the patient is happy to continue in the study. The criteria for crossover this will be Grade 2 or greater diastolic dysfunction as per the British Society of Echocardiography Diastolic Dysfunction guidelines. If the BNP level is not raised, despite meeting imaging criteria for diastolic dysfunction, the patient will not be eligible for the full analysis and the second visit will not be performed.
Patients in the diseased cohort will represent a range of pathologies that typically cause HFPEF (heart failure with preserved ejection fraction), including hypertrophic cardiomyopathy, aortic stenosis, and cardiac amyloidosis.
On the same day as their clinical CMR scan, participants will undergo a focused research echocardiogram which will include quantification of left atrium size, trans-mitral Doppler, tissue Doppler imaging and global longitudinal strain (GLS). All measurements will be performed in both left lateral decubitus positioning (typical for echocardiography) and supine positioning (typical for CMR).
Participants will then undergo their clinical CMR scan.
After their CMR scan, patients will then undergo repeat focused echocardiography.
When patients return for their clinical follow-up, they will undergo a repeat focused echocardiogram and 15-minute research CMR scan.
This design allows the agreement between each CMR and echocardiographic measure of diastolic function to be assessed. More importantly, this agreement can be described in the context of:
- Changes in diastolic function parameters due to patient positioning
- Changes in diastolic function parameters during a scan, e.g. due to the patient relaxing
- Each modality's test re-test reproducibility over two timescales (less than 1 hour versus several weeks).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paired cardiac MRI and echocardiographic measurements | Experimental | Diagnostic Test: Cardiac MRI scan, Diagnostic Test: Echocardiogram scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cohort 1: patients with preserved systolic function, grade 2 or more diastolic dysfunction on echocardiography, a raised BNP, and a diagnosis typically causing HFPEF (e.g., hypertrophic cardiomyopathy, severe aortic stenosis, or cardiac amyloidosis).
- Cohort 2: patients without grade 2 or more diastolic dysfunction on echocardiography.
Key exclusion criteria (5 listed)
- Contraindications to CMR or echocardiographic scanning - for safety.
- Contraindications to gadolinium contrast agents - for safety.
- Severe claustrophobia - extra CMR scanning may prove too difficult.
- Pregnancy - likely to be undergoing progressive physiological changes in the conduct of the study which may invalid assumptions about repeat scanning.
- The ability to provide informed consent.
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 MRI scanUndertaken at the radiology department at Hammersmith Hospital. The scan will be performed by the MRI radiographers, under the supervision of a consultant radiologist or cardiologist. | Diagnostic test | Paired cardiac MRI and echocardiographic measurements |
| Echocardiogram scanUndertaken at the Peart Rose research unit, by a British Society of Echocardiography accredited sonographer. | Diagnostic test | Paired cardiac MRI and echocardiographic measurements |
Primary outcome
Diagnostic accuracy using e:E'
Time frame: 15 weeks
The accuracy rate using the ratio (dimensionless) of early mitral valve inflow (centimetres per second) to the mitral valve peak relaxation velocity (centimeters per second), measured using echocardiography and cardiac MRI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac MRI scan and Echocardiogram scan in people with Diastolic Dysfunction, run by Imperial College London at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 2 Mar 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 United Kingdom. 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?
Contact Becky Ward (0207 594 9459, becky.ward@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy using e:E' (time frame: 15 weeks). 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 2 Mar 2023.