NCT02973633 Diffusion MRI in Heart Failure
| NCT ID | NCT02973633 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Massachusetts General Hospital |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2017-06-30 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 160 participants in total. It began in 2017-06-30 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
David E. Sosnovik, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT02973633 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02973633 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02973633 currently recruiting?
Yes, NCT02973633 is actively recruiting participants. Contact the research team at sosnovik@nmr.mgh.harvard.edu for enrollment information.
Where is the NCT02973633 trial being conducted?
This trial is being conducted at Charlestown, United States.
Who is sponsoring the NCT02973633 clinical trial?
NCT02973633 is sponsored by Massachusetts General Hospital. The principal investigator is David E. Sosnovik, MD at Massachusetts General Hospital. The trial plans to enroll 160 participants.
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