Diffusion MRI in Heart Failure

ConditionsHeart Failure Myocardial Infarction Left Ventricular Hypertrophy

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-85

SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Diffusion Tensor MRI (DTI)
Device
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.
Gadolinium DOTA Meglumine
Drug
Late Gadolinium enhancement

Treatment groups

160 Participants

are divided into 3 treatment groups

Group A: Healthy VolunteersActive comparator 1 intervention

Group B: Patients with Recent Myocardial InfarctionActive comparator 2 interventions

Group C: Patients with Left Ventricular HypertrophyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

12 months

Secondary outcomes

Correlation of Myofiber Helix Angle and Strain

The investigators aim to correlate how changes in fiber architecture correlate with changes in left ventricular strain.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov

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