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Diffusion MRI in Heart Failure

Diffusion MRI in Heart Failure

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02973633
Enrollment
160
Registered
2016-11-25
Start date
2017-06-30
Completion date
2028-12-31
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Left Ventricular Hypertrophy, Myocardial Infarction

Keywords

Heart Failure, Remodeling, Myocardial Infarction, Left Ventricular Hypertrophy, Diffusion Tensor MRI

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.

Interventions

DEVICEDiffusion 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.

DRUGGadolinium DOTA Meglumine

Late Gadolinium enhancement

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Myofiber Helix Angle12 monthsThe investigators aim to determine how the myofibers in the heart change their orientation in heart disease by measuring their helix angle.

Secondary

MeasureTime frameDescription
Correlation of Myofiber Helix Angle and Strain12 monthsThe investigators aim to correlate how changes in fiber architecture correlate with changes in left ventricular strain.

Countries

United States

Contacts

Primary ContactDavid E. Sosnovik, MD
sosnovik@nmr.mgh.harvard.edu617-724-3407

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026