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NCT Number: NCT02973633

Diffusion MRI in Heart Failure

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.

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Key information

Conditions

Heart Failure Cardiomegaly Cardiovascular Diseases Heart Diseases Hypertrophy Hypertrophy, Left Ventricular Infarction Ischemia Left Ventricular Hypertrophy Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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)
  • Known untreated ventricular arrhythmia such as sustained ventricular tachycardia within last 12 months
  • Atrial fibrillation that is not well rate controlled (heart rate >125)
  • Unstable angina within last 2 months that has not been fully evaluated by a cardiologist
  • Syncope within last 6 weeks
  • Hemodynamic instability (Systolic BP less than 100 or greater than 180)
  • Decompensated heart failure (inability to lie flat and perform a breath-hold).
  • Glomerular filtration rate (GFR) < 60 for those receiving gadolinium.
  • Labile GFR that is not stable/similar on last 2 measurements (for those receiving gadolinium).
  • Patients with GFR < 20 or on any form of dialysis.
  • Infiltrative cardiomyopathy (amyloid, sarcoid, hemachromatosis)
  • Recent surgery (within the last 3 months)
  • Prior stroke with large residual deficit
  • Presence of liver or respiratory failure
  • Pregnancy and nursing mothers
  • Claustrophobia
  • Known seizure disorder

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David E. Sosnovik, MD

CONTACT

[email protected]

617-724-3407

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2027
Study completion
2028
First posted
Nov 25, 2016
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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