Diffusion MRI in Heart Failure

Heart Failure Clinical Trial

Official title:

Diffusion MRI in Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02973633
• Other study ID #: 2016P001898
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 30, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Massachusetts General Hospital
• Contact: David E. Sosnovik, MD
• Phone: 617-724-3407
• Email: sosnovik[@]nmr.mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Hypertrophy
• Hypertrophy, Left Ventricular
• Infarction
• Left Ventricular Hypertrophy
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mekkaoui C, Reese TG, Jackowski MP, Cauley SF, Setsompop K, Bhat H, Sosnovik DE. Diffusion Tractography of the Entire Left Ventricle by Using Free-breathing Accelerated Simultaneous Multisection Imaging. Radiology. 2017 Mar;282(3):850-856. doi: 10.1148/ra — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Correlation of Myofiber Helix Angle and Strain	The investigators aim to correlate how changes in fiber architecture correlate with changes in left ventricular strain.	12 months