Diffusion MRI in Heart Failure

Mass General Brigham

Status and phase: Enrolling; Early Phase 1

Conditions: Myocardial Infarction; Left Ventricular Hypertrophy; Heart Failure

Treatments: Drug: Gadolinium DOTA Meglumine; Device: Diffusion Tensor MRI (DTI)

Study type: Interventional

Funder types: Other

Identifiers

NCT02973633

2016P001898

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 3 patient groups

Healthy Volunteers

Active Comparator group

Description:

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.

Treatment:

Device: Diffusion Tensor MRI (DTI)

Patients with Recent Myocardial Infarction

Active Comparator group

Description:

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.

Treatment:

Device: Diffusion Tensor MRI (DTI)

Drug: Gadolinium DOTA Meglumine

Patients with Left Ventricular Hypertrophy

Active Comparator group

Description:

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.

Treatment:

Device: Diffusion Tensor MRI (DTI)