Diffusion MRI to image heart muscle microstructure in people after a heart attack or with left ventricular hypertrophy.

Diffusion MRI in Heart Failure

This trial will try diffusion tensor MRI to see if it can detect tiny changes in heart muscle in people who recently had a heart attack, have left ventricular hypertrophy, or are at risk for heart failure.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Charlestown, Massachusetts)
• Trial ID: NCT02973633 on ClinicalTrials.gov

What this trial studies

Researchers will enroll healthy volunteers, people 6–10 weeks after an ST-elevation myocardial infarction who are angina-free, and patients with a heart failure episode within the past 12 months with documented left ventricular hypertrophy. Participants will undergo serial diffusion tensor MRI (DTI) of the heart, with gadolinium contrast as indicated, to map water diffusion and infer myocardial microstructure over time. The imaging series aims to identify microstructural remodeling that may precede symptomatic heart failure and to distinguish compensated from decompensated myocardium. Imaging findings will be compared with clinical history and standard cardiac imaging to characterize temporal changes.

Who should consider this trial

Good fit: Ideal candidates are adults who are healthy controls, people 6–10 weeks after an ST-elevation myocardial infarction who are angina-free and followed by a cardiologist, or patients with a heart failure episode within the last 12 months plus documented left ventricular hypertrophy.

Not a fit: Patients with implanted pacemakers/defibrillators or other excluded metallic devices, recent coronary stents, uncontrolled arrhythmias, unstable angina, syncope or hemodynamic instability are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could enable earlier detection of harmful microstructural remodeling and improve understanding of how heart failure develops, potentially guiding earlier or more targeted interventions.

How similar studies have performed: Diffusion MRI of the heart is an emerging technique with promising animal and small human studies but remains relatively novel with limited large-scale clinical validation.

Eligibility criteria

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

Where this trial is running

Charlestown, Massachusetts

• Massachusetts General Hospital — Charlestown, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: David E. Sosnovik, MD — Massachusetts General Hospital
• Study coordinator: David E. Sosnovik, MD

Conditions Heart Failure; Myocardial Infarction; Left Ventricular Hypertrophy; Remodeling; Diffusion Tensor MRI