Diffusion MRI in Heart Failure

December 18, 2025 updated by: David E Sosnovik, Massachusetts General Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Recruiting
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. Presence of metallic foreign bodies/objects
  2. Selected medical devices and implants
  3. Pacemakers, implantable defibrillators, life vests
  4. Coronary artery stent within last 6 weeks (unless the stent is a MRI-inert chromium-cobalt stent)
  5. Known untreated ventricular arrhythmia such as sustained ventricular tachycardia within last 12 months
  6. Atrial fibrillation that is not well rate controlled (heart rate >125)
  7. Unstable angina within last 2 months that has not been fully evaluated by a cardiologist
  8. Syncope within last 6 weeks
  9. Hemodynamic instability (Systolic BP less than 100 or greater than 180)
  10. Decompensated heart failure (inability to lie flat and perform a breath-hold).
  11. Glomerular filtration rate (GFR) < 60 for those receiving gadolinium.
  12. Labile GFR that is not stable/similar on last 2 measurements (for those receiving gadolinium).
  13. Patients with GFR < 20 or on any form of dialysis.
  14. Infiltrative cardiomyopathy (amyloid, sarcoid, hemachromatosis)
  15. Recent surgery (within the last 3 months)
  16. Prior stroke with large residual deficit
  17. Presence of liver or respiratory failure
  18. Pregnancy and nursing mothers
  19. Claustrophobia
  20. Known seizure disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy Volunteers
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.
Device: 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.
Active Comparator: Patients with Recent Myocardial Infarction
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.
Device: 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.
Drug: Gadolinium DOTA Meglumine
Late Gadolinium enhancement
Active Comparator: Patients with Left Ventricular Hypertrophy
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Myofiber Helix Angle and Strain
Time Frame: 12 months
The investigators aim to correlate how changes in fiber architecture correlate with changes in left ventricular strain.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: David E. Sosnovik, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2017

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 19, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimated)

November 25, 2016

Study Record Updates

Last Update Posted (Estimated)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P001898

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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