MRI for Heart Failure

Recruiting at 1 trial location

Overseen By Jason Ortman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pregnancy, Metal fragments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Who Is on the Research Team?

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.

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?

Group I: Non-Hospitalized Experimental Treatment 1 Intervention

Participants who had heart failure (HF) but did not require hospitalization secondary to the illness.

Group II: Hospitalized Experimental Treatment 1 Intervention

Participants who were hospitalized due to heart failure (HF) illness.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acceleration of cardiovascular MRI using parallel imaging: basic principles, practical considerations, clinical applications and future directions]. Niendorf, T., Sodickson, D.[2006]

Cardiac magnetic resonance imaging (CMR) is a highly accurate and non-invasive method for assessing valvular heart disease (VHD), offering advantages over echocardiography, especially in patients with body habitus-related limitations.

CMR provides precise measurements of valvular dysfunction and ventricular burden, making it an excellent tool for clinical follow-up and evaluating the effectiveness of therapeutic interventions in VHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac magnetic resonance imaging in valvular heart disease. Koskenvuo, JW., Järvinen, V., Pärkkä, JP., et al.[2009]

Cardiovascular magnetic resonance imaging (CMR) is crucial for diagnosing and assessing heart failure, providing accurate and reproducible evaluations without the use of radiation.

CMR not only helps identify the cause of heart failure but also offers detailed insights into heart structure and function, including the assessment of conditions like iron overload cardiomyopathy and emerging roles in cardiac amyloid and Anderson-Fabry disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Cardiovascular Magnetic Resonance Imaging in Heart Failure. Peterzan, MA., Rider, OJ., Anderson, LJ.[2021]

In a study of 671 MR imaging procedures using ferumoxytol in 331 patients, no serious or life-threatening adverse events were reported, indicating a strong safety profile for this contrast agent.

The overall rate of mild adverse events was 10.6%, with common issues including hypertension and nausea, suggesting that while some patients may experience side effects, serious complications are rare when proper precautions are taken.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent. Varallyay, CG., Toth, GB., Fu, R., et al.[2023]

In a study of 728 patients and 25 volunteers, regadenoson stress cardiac magnetic resonance (CMR) was found to be safe, with no serious adverse events like death or myocardial infarction reported.

The most common side effects were mild, including dyspnoea (30%), chest discomfort (27%), and headache (15%), indicating that while some patients experienced discomfort, the overall tolerability of regadenoson CMR is high.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of regadenoson CMR. Nguyen, KL., Bandettini, WP., Shanbhag, S., et al.[2021]

Cardiovascular magnetic resonance (CMR) is a highly accurate and reproducible imaging technique that effectively measures heart function, including left and right ventricular volumes and mass, making it essential for assessing heart failure patients.

CMR not only aids in initial evaluations and ongoing monitoring of cardiac function but also helps predict patient prognosis and assess the effects of therapies on heart remodeling, even in studies with small sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serial assessment of ventricular morphology and function. Grothues, F., Braun-Dullaeus, R.[2009]

In a study of 154,779 patients undergoing cardiac MRI, gadolinium-based contrast agents (GBCAs) were used in 94.2% of cases, with a significant shift towards macrocyclic agents following regulatory changes, which showed a favorable acute safety profile.

The overall rate of acute adverse events (AAEs) associated with GBCAs was low at 0.36%, with severe events occurring in only 0.03% of patients, indicating that GBCAs, particularly macrocyclic types, are generally safe for use in cardiac imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadolinium-based Contrast Agents for Cardiac MRI: Use of Linear and Macrocyclic Agents with Associated Safety Profile from 154 779 European Patients. Uhlig, J., Al-Bourini, O., Salgado, R., et al.[2022]

In a study involving 17,767 patients across 45 European centers, only 30 acute adverse reactions (0.17%) were reported after administering gadolinium-based contrast agents during cardiac magnetic resonance imaging, all classified as mild.

The most common reactions included rashes, hives, nausea, and anxiety, with the incidence of adverse events being comparable to that seen in general radiology settings, indicating that the off-label use of these agents in CMR is safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute adverse reactions to gadolinium-based contrast agents in CMR: multicenter experience with 17,767 patients from the EuroCMR Registry. Bruder, O., Schneider, S., Nothnagel, D., et al.[2016]

The study found that cardiovascular magnetic resonance feature tracking (CMR-FT) shows good to excellent reproducibility for measuring myocardial motion in a mouse model, particularly for global circumferential and longitudinal strain, which are important for assessing heart function.

A preliminary sample size calculation indicated that as few as ten mice could be sufficient for future studies to detect significant changes in myocardial strain, suggesting that CMR-FT could be a practical tool for small-scale animal research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance feature tracking in small animals - a preliminary study on reproducibility and sample size calculation. Lapinskas, T., Grune, J., Zamani, SM., et al.[2018]

Advancements in medical care have significantly improved survival rates for adults with congenital heart disease, leading to increased use of cardiac magnetic resonance imaging (MRI) in their management.

Recent developments in MRI technology, such as 4-dimensional phase-contrast imaging and 3-dimensional modeling, are now routinely used in clinical practice to assess heart function, detect myocardial issues, and aid in preinterventional planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging Adults With Congenital Heart Disease Part II: Advanced CMR Techniques. Sahu, A., Slesnick, TC.[2018]

Magnetic resonance imaging (MRI) is crucial for accurately diagnosing patients with heart failure caused by valvular heart disease, helping to differentiate them from those with other causes of heart failure.

Given the significant prevalence of heart failure, affecting 5.8 million people in the U.S. and over 223 million globally, MRI's role in diagnosis and prognosis is vital for effective patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Magnetic Resonance in Valvular Heart Disease-Related Heart Failure. Uretsky, S., Wolff, SD.[2021]

Cardiovascular magnetic resonance (CMR) is the gold standard for assessing heart function, volumes, and mass, and it can also visualize myocardial infarction using gadolinium contrast, aiding in heart failure diagnosis and treatment planning.

Emerging CMR techniques, such as dobutamine stress testing and perfusion imaging, offer advantages over traditional methods and could provide valuable insights into heart conditions, but increasing access to these advanced imaging techniques remains a significant challenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance and the evaluation of heart failure. Moon, JC., Prasad, SK.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7939452/

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.

2.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.124.039889

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%); ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1097664723005410

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 ...

4.

mdpi.com

mdpi.com/2308-3425/12/6/200

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 ...

5.

jwatch.org

jwatch.org/na57977/2024/10/28/cardiac-magnetic-resonance-imaging-risk-stratification

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), ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11200101/

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 ...

7.

acc.org

acc.org/Latest-in-Cardiology/Articles/2024/05/21/10/30/Current-State-of-MRI-With-Cardiac-Devices

Current State of MRI With Cardiac Devices

MRI examinations in patients with CIEDs are safe when rigorous protocols are followed regardless of the type of CIED.

8.

ahajournals.org

ahajournals.org/doi/10.1161/circulationaha.107.187256

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 ...

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S1050173821000852

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 ...

10.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1604267

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 ...