Diffusion MRI in Heart Failure
1 other identifier
interventional
160
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 heart-failure
Started Jun 2017
Longer than P75 for early_phase_1 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2016
CompletedFirst Posted
Study publicly available on registry
November 25, 2016
CompletedStudy Start
First participant enrolled
June 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
December 24, 2025
December 1, 2025
10.5 years
November 19, 2016
December 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months
Secondary Outcomes (1)
Correlation of Myofiber Helix Angle and Strain
12 months
Study Arms (3)
Healthy Volunteers
ACTIVE COMPARATORDTI 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 COMPARATORPatients 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 COMPARATORPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- 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)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
Related Publications (1)
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.
PMID: 27681278RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David E. Sosnovik, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine, Harvard Medical School
Study Record Dates
First Submitted
November 19, 2016
First Posted
November 25, 2016
Study Start
June 30, 2017
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
IPD will not be shared