BridgeMD
New treatment option for Heart Failure
Official title Diffusion MRI in Heart Failure
ClinicalTrials.gov ID: NCT02973633
What this study is testing
What is Gadolinium DOTA Meglumine?
Gadolinium DOTA Meglumine is an investigational medicine, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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)
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Charlestown, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlestown, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.