Diffusion MRI in Heart Failure

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02973633
• Collaborator: (none)
• Enrollment: 160
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 66
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Myocardial Infarction; Left Ventricular Hypertrophy	Device: Diffusion Tensor MRI (DTI); Drug: Gadolinium DOTA Meglumine	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Diffusion MRI in Heart Failure
• Actual Study Start Date: Jun 30, 2017
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Healthy Volunteers 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.	Device: Diffusion 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.
Active Comparator: Patients with Recent Myocardial Infarction 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.	Device: Diffusion 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.; Drug: Gadolinium DOTA Meglumine; Late Gadolinium enhancement
Active Comparator: Patients with Left Ventricular Hypertrophy 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.	Device: Diffusion 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.

Outcome Measures

Primary Outcome Measures

1. Myofiber Helix Angle [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 Outcome Measures

1. Correlation of Myofiber Helix Angle and Strain [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Charlestown	Massachusetts	United States	02129

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: David E. Sosnovik, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David E Sosnovik, Associate Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02973633
• Other Study ID Numbers: 2016P001898
• First Posted: Nov 25, 2016
• Last Update Posted: Mar 2, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by David E Sosnovik, Associate Professor of Medicine, Harvard Medical School, Massachusetts General Hospital: Heart Failure; Remodeling; Myocardial Infarction; Left Ventricular Hypertrophy; Diffusion Tensor MRI
• Additional relevant MeSH terms: Heart Failure; Myocardial Infarction; Hypertrophy, Left Ventricular; Infarction; Hypertrophy; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate

Study Results

No Results Posted as of Mar 2, 2022