Heart FailureEarly Phase 1NCT02973633
Diffusion MRI in Heart Failure
A Early Phase 1 study testing Diffusion Tensor MRI (DTI) and Gadolinium DOTA Meglumine in people with Heart Failure and Myocardial Infarction, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The development of symptomatic heart failure is frequently preceded by a pre-clinical period of structural remodeling in the heart. The remodeling process driving this transition, however, remains poorly understood. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Myocardial Infarction, Left Ventricular Hypertrophy
- What is being tested?
- Diffusion Tensor MRI (DTI) and Gadolinium DOTA Meglumine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2017to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults with no history of hypertension, diabetes or heart disease
- Patients with ST Elevation MI within last 6-10 weeks who are angina free, and have been seen by a cardiologist since discharge
- Patients with episode of heart failure within last 12 months and left ventricular hypertrophy, documented by echocardiogram or MRI.
Who cannot join
- Presence of metallic foreign bodies/objects
- Selected medical devices and implants
- Pacemakers, implantable defibrillators, life vests
- Coronary artery stent within last 6 weeks (unless the stent is a MRI-inert chromium-cobalt stent)
- Known untreated ventricular arrhythmia such as sustained ventricular tachycardia within last 12 months
- Atrial fibrillation that is not well rate controlled (heart rate >125)
Show all 20Show fewer
- Unstable angina within last 2 months that has not been fully evaluated by a cardiologist
- Syncope within last 6 weeks
- Hemodynamic instability (Systolic BP less than 100 or greater than 180)
- Decompensated heart failure (inability to lie flat and perform a breath-hold).
- Glomerular filtration rate (GFR) < 60 for those receiving gadolinium.
- Labile GFR that is not stable/similar on last 2 measurements (for those receiving gadolinium).
- Patients with GFR < 20 or on any form of dialysis.
- Infiltrative cardiomyopathy (amyloid, sarcoid, hemachromatosis)
- Recent surgery (within the last 3 months)
- Prior stroke with large residual deficit
- Presence of liver or respiratory failure
- Pregnancy and nursing mothers
- Claustrophobia
- Known seizure disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
About this study
The development of symptomatic heart failure is frequently preceded by a pre-clinical period of structural remodeling in the heart. The remodeling process driving this transition, however, remains poorly understood. The investigators hypothesize that imaging the diffusion of water in the heart with MRI will allow its microstructure to be resolved. The investigators further hypothesize that the characterization of microstructural changes in the heart will help elucidate the pathogenesis of heart failure and the transition from a compensated to a decompensated state. Patients with recent myocardial infarcts and left ventricular hypertrophy, who are at risk for the development of heart failure, will be enrolled. The participants will undergo serial diffusion tensor MRI (DTI) imaging of the heart to characterize changes in myocardial microstructure over time.
- Being tested
- Diffusion Tensor MRI (DTI), Gadolinium DOTA Meglumine
- Keywords
- Heart Failure, Remodeling, Myocardial Infarction, Left Ventricular Hypertrophy, Diffusion Tensor MRI
- Medical subject headings
- Heart Failure, Myocardial Infarction, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion Tensor MRI (DTI)Device
Diffusion Tensor MRI (DTI) measures the diffusion of water in the heart, which allows the orientation of the muscle fibers in the heart to be determined.
Gadolinium DOTA MeglumineDrug
Late Gadolinium enhancement
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Active comparator | DTI will be performed in healthy volunteers to characterize normal fiber architecture in the heart and provide a comparison group for the patients imaged in the other arms. Receives: Device: Diffusion Tensor MRI (DTI) |
| Patients with Recent Myocardial Infarction | Active comparator | Patients with recent ST elevation myocardial infarcts will be recruited and imaged serially with DTI to detect changes in fiber architecture and their correlation with remodeling of the left ventricle. Receives: Device: Diffusion Tensor MRI (DTI); Drug: Gadolinium DOTA Meglumine |
| Patients with Left Ventricular Hypertrophy | Active comparator | Patients with left ventricular hypertrophy and a history of heart failure will be recruited and imaged serially with DTI to detect changes in fiber architecture and their correlation with the onset and progression of heart failure. Receives: Device: Diffusion Tensor MRI (DTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myofiber Helix Angle
The investigators aim to determine how the myofibers in the heart change their orientation in heart disease by measuring their helix angle.
Measured: 12 months
Secondary outcomes (1)
Correlation of Myofiber Helix Angle and Strain
The investigators aim to correlate how changes in fiber architecture correlate with changes in left ventricular strain.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study start30 Jun 2017
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David E Sosnovik, Massachusetts General Hospital
- Investigators
- David E. Sosnovik, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973633
- Sponsor's protocol ID
- 2016P001898
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2016
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared
Publications
Mekkaoui C, Reese TG, Jackowski MP, Cauley SF, Setsompop K, Bhat H, Sosnovik DE. Diffusion Tractography of the Entire Left Ventricle by Using Free-breathing Accelerated Simultaneous Multisection Imaging. Radiology. 2017 Mar;282(3):850-856. doi: 10.1148/radiol.2016152613. Epub 2016 Sep 28.
PubMed 27681278
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion MRI in Heart Failure
- ClinicalTrials.gov ID
- NCT02973633
- Acronym / sponsor ID
- 2016P001898
- Keywords
- Heart Failure, Remodeling, Myocardial Infarction, Left Ventricular Hypertrophy, Diffusion Tensor MRI
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Nov 2016 (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.
The development of symptomatic heart failure is frequently preceded by a pre-clinical period of structural remodeling in the heart. The remodeling process driving this transition, however, remains poorly understood. The investigators hypothesize that imaging the diffusion of water in the heart with MRI will allow its microstructure to be resolved. The investigators further hypothesize that the characterization of microstructural changes in the heart will help elucidate the pathogenesis of heart failure and the transition from a compensated to a decompensated state. Patients with recent myocardial infarcts and left ventricular hypertrophy, who are at risk for the development of heart failure, will be enrolled. The participants will undergo serial diffusion tensor MRI (DTI) imaging of the heart to characterize changes in myocardial microstructure over time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Active comparator | Device: Diffusion Tensor MRI (DTI)DTI will be performed in healthy volunteers to characterize normal fiber architecture in the heart and provide a comparison group for the patients imaged in the other arms. |
| Patients with Recent Myocardial Infarction | Active comparator | Device: Diffusion Tensor MRI (DTI), Drug: Gadolinium DOTA MegluminePatients with recent ST elevation myocardial infarcts will be recruited and imaged serially with DTI to detect changes in fiber architecture and their correlation with remodeling of the left ventricle. |
| Patients with Left Ventricular Hypertrophy | Active comparator | Device: Diffusion Tensor MRI (DTI)Patients with left ventricular hypertrophy and a history of heart failure will be recruited and imaged serially with DTI to detect changes in fiber architecture and their correlation with the onset and progression of heart failure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults with no history of hypertension, diabetes or heart disease
- Patients with ST Elevation MI within last 6-10 weeks who are angina free, and have been seen by a cardiologist since discharge
- Patients with episode of heart failure within last 12 months and left ventricular hypertrophy, documented by echocardiogram or MRI.
Key exclusion criteria (20 listed)
- Presence of metallic foreign bodies/objects
- Selected medical devices and implants
- Pacemakers, implantable defibrillators, life vests
- Coronary artery stent within last 6 weeks (unless the stent is a MRI-inert chromium-cobalt stent)
- Known untreated ventricular arrhythmia such as sustained ventricular tachycardia within last 12 months
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 |
|---|---|---|
| Diffusion Tensor MRI (DTI)Diffusion Tensor MRI (DTI) measures the diffusion of water in the heart, which allows the orientation of the muscle fibers in the heart to be determined. | Device | Healthy Volunteers, Patients with Left Ventricular Hypertrophy, Patients with Recent Myocardial Infarction |
| Gadolinium DOTA MeglumineLate Gadolinium enhancement | Drug | Patients with Recent Myocardial Infarction |
Primary outcome
Myofiber Helix Angle
Time frame: 12 months
The investigators aim to determine how the myofibers in the heart change their orientation in heart disease by measuring their helix angle.
1 secondary outcome
Correlation of Myofiber Helix Angle and Strain
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Results publication: PubMed 27681278Mekkaoui C, Reese TG, Jackowski MP, Cauley SF, Setsompop K, Bhat H, Sosnovik DE. Diffusion Tractography of the Entire Left Ventricle by Using Free-breathing Accelerated Simultaneous Multisection Imaging. Radiology. 2017 Mar;282(3):850-856. doi: 10.1148/radiol.2016152613. Epub 2016 Sep 28.
- Individual participant dataSharing planned: No. IPD will not be shared
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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.
David E. Sosnovik, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Diffusion Tensor MRI (DTI) and Gadolinium DOTA Meglumine in people with Heart Failure and Myocardial Infarction, run by Massachusetts General Hospital at 1 site in United States.
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 3 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. 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 States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David E. Sosnovik, MD (617-724-3407, sosnovik@nmr.mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myofiber Helix Angle (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02973633, which also lists 1 linked publication.
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 Dec 2025.