NCT02973633RecruitingEarly phase 1
Diffusion MRI in Heart Failure
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 19 Nov 2016
- Start date
- 30 Jun 2017
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT02973633
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 160
- From 30 Jun 2017 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Selected medical devices and implants
- Recent surgery (within the last 3 months)
- Prior stroke with large residual deficit
Other illness
- 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
- Decompensated heart failure (inability to lie flat and perform a breath-hold).
- Presence of liver or respiratory failure
- Known seizure disorder
Lab values
- 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.
Other
- Presence of metallic foreign bodies/objects
- Pacemakers, implantable defibrillators, life vests
- Coronary artery stent within last 6 weeks (unless the stent is a MRI-inert chromium-cobalt stent)
- Syncope within last 6 weeks
- Hemodynamic instability (Systolic BP less than 100 or greater than 180)
- Infiltrative cardiomyopathy (amyloid, sarcoid, hemachromatosis)
- Pregnancy and nursing mothers
- Claustrophobia
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Charlestown | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.