100 Participants Needed

MRI for Heart Failure

Recruiting at 1 trial location
JL
JO
Overseen ByJason Ortman
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how heart failure might affect the brain. Researchers will use MRI (Magnetic Resonance Imaging) scans to examine brain structures in people with heart failure and compare them to those with normal heart function. The goal is to determine if heart problems could accelerate brain changes, possibly explaining the higher dementia risks in heart failure patients. This trial suits individuals with heart failure, whether hospitalized or not, who have an ejection fraction (a measure of heart pumping ability) below 50%, and do not suffer from severe claustrophobia. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on the link between heart failure and brain health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this MRI protocol is safe for heart failure patients?

Past studies have shown that MRI (Magnetic Resonance Imaging) is very safe for most people. Research indicates that MRIs are even safe for patients with heart devices, like pacemakers, when proper safety steps are followed. Many studies have examined various heart conditions and found that MRIs do not cause harm when used carefully.

These findings suggest that MRI is generally well-tolerated and carries a low risk of side effects. However, discussing any concerns with the research team before joining a study is important. They can provide more details about the MRI process and how they will ensure safety during the trial.12345

Why are researchers excited about this trial?

Researchers are excited about using Magnetic Resonance Imaging (MRI) for heart failure because it offers a non-invasive way to get detailed images of the heart, potentially providing insights that standard treatments like medication or surgery can't offer. Unlike traditional methods that focus on symptom management or improving heart function through drugs or devices, MRI can help identify the underlying causes of heart failure with precision. This could lead to more personalized treatment plans and better outcomes for patients, as doctors can tailor interventions based on specific heart conditions revealed by the MRI.

What evidence suggests that this MRI protocol is effective for studying brain changes in heart failure patients?

Research has shown that Magnetic Resonance Imaging (MRI) aids in understanding heart failure. In this trial, participants will be divided into two groups: those hospitalized due to heart failure and those who were not. Studies have found that cardiac MRI detects new heart issues in about 27% of people with heart failure. This detection helps doctors predict risks such as death and serious heart problems. MRI also identifies changes in the brain related to heart function. This is crucial because heart failure is linked to brain changes that might affect memory and thinking. MRI can further explore these connections.678910

Who Is on the Research Team?

JA

Joao AC Lima, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 21 who can walk on their own and have heart failure with an ejection fraction below 50%. They must not be claustrophobic to undergo MRI scans. Participants need to give informed consent.

Inclusion Criteria

My heart's ejection fraction is below 50%, and I am willing to...
I am 21 years old or older.
I have given my informed consent.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo MRI to measure subcortical brain volumes and assess cardiac parameters

1 week
1 visit (in-person)

Follow-up

Participants are monitored for changes in subcortical volumes and cardiac function

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Magnetic Resonance Imaging
Trial Overview The study uses MRI imaging, with or without contrast, to measure brain volumes in people with heart failure. It aims to find links between the size of certain brain areas and heart function, comparing these findings with those from healthy hearts.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Non-HospitalizedExperimental Treatment1 Intervention
Group II: HospitalizedExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Canon Medical Systems, USA

Industry Sponsor

Trials
14
Recruited
1,300+

Published Research Related to This Trial

Cardiac MRI is a powerful tool for assessing heart health, but it is not used as much as it could be, despite its proven effectiveness in various applications.
Recent advancements in low-field MRI technology have shown that it can provide high-quality images and may open new clinical opportunities, such as imaging patients with metal implants or severe obesity, making cardiac MRI more accessible and cost-effective.
Cardiac MRI at Low Field Strengths.Campbell-Washburn, AE., Varghese, J., Nayak, KS., et al.[2023]
In a study involving 577 patients with acute and chronic myocardial infarction, gadoversetamide was found to be safe as a contrast agent for delayed hyperenhancement MRI, with no serious adverse events linked to its use.
Out of the patients, 21.5% reported mild to moderate adverse events, primarily ECG-related, but only a few were considered likely related to gadoversetamide, indicating a favorable safety profile.
Safety of gadoversetamide in patients with acute and chronic myocardial infarction.Huber, S., Muthupillai, R., Cheong, B., et al.[2017]
Cardiovascular Magnetic Resonance (CVMR) imaging is a valuable non-invasive tool for diagnosing cardiovascular diseases, and its efficiency can be significantly enhanced using parallel MRI techniques that allow for simultaneous data acquisition.
Parallel MRI improves imaging speed and quality, enabling shorter examination times, better spatial and temporal resolution, and the ability to correct for patient movement, which can lead to more accurate diagnoses and streamlined workflows in clinical settings.
[Acceleration of cardiovascular MRI using parallel imaging: basic principles, practical considerations, clinical applications and future directions].Niendorf, T., Sodickson, D.[2006]

Citations

Cardiovascular Magnetic Resonance Imaging and Heart ...Cardiac magnetic resonance (CMR) has become a useful non-invasive tool for the diagnosis and assessment of prognosis in patients suffering from heart failure.
Outcomes and Left Ventricular Ejection Fraction in Cardiac ...The overall composite outcome was 7.9% (2.53 per 100 person‐years). The individual outcomes were as follows: heart failure, 143 (4.4%); ...
Diagnostic and prognostic utility of cardiovascular ...CMR diagnosed new significant pathology in 27% of patients with HFpEF. These patients were at increased risk of death and heart failure ...
Cardiac Magnetic Resonance in Heart Failure: Diagnostic ...The largest body of evidence indicates that LGE is the most effective risk predictor of all-cause mortality, cardiac mortality, and major adverse cardiac events ...
Cardiac Magnetic Resonance Imaging for Risk ...LGE was associated with significantly greater risks for all-cause death (hazard ratios: any LGE, 1.81; per 1% greater LGE extent, 1.07), ...
Safety of magnetic resonance imaging in patients with cardiac ...Based on the available data, caution and a comprehensive risk–benefit assessment are recommended, especially in functional and abandoned ...
Current State of MRI With Cardiac DevicesMRI examinations in patients with CIEDs are safe when rigorous protocols are followed regardless of the type of CIED.
Safety of Magnetic Resonance Imaging in Patients With ...Numerous clinical studies have demonstrated the safety of performing MR examinations in patients with prosthetic heart valves. Of note, 28 ...
Magnetic resonance imaging safety in patients with cardiac ...Indeed, MRI has a very positive safety profile for the majority of the general population, and offers this diagnostic information using high strength electric ...
Safety of Magnetic Resonance Imaging in Patients with ...We evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a ...
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