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

Trial Summary

What is the purpose of this trial?

Patients with heart failure (HF) exhibit greater structural brain alterations and higher dementia risks than the general population. Neural atrophy in nearly every region of medical limbic circuit has been observed in HF patients. Reduction of cerebral blood flow has been suggested as the pathophysiological pathway linking HF and structural brain changes. Indeed, lower cardiac index levels were related to lower cerebral blood flow in older adults without stroke, dementia, or heart failure. A few prior studies have examined the subcortical structural differences in patients with HF compared to controls. Brain volume loss (including putamen and hippocampal volumes) have been reported in patients with low ejection fraction. Significant gray matter loss was found in specific brain regions of HF patients and included structures that serve demonstrated roles in cognitive functions. In the investigator's previous study (Comprehensive Imaging Exam of Convalesced COVID-19 Patients - COVID-19 RELATED SUBMISSION-IRB00252436), involving 100 participants (volunteers with normal heart function (ejection fraction; 50%)), the investigators observed significant correlations between thalamic volumes and ventricular stroke volumes in volunteers. Building on these findings, the investigators intend to expand the research to include individuals with heart failure (HF), employing the same MRI protocol. The study will involve obtaining a set of T1-weighted brain images to measure the volumes of seven subcortical structures. The investigators goal is to explore the relationship between subcortical volumes and cardiac parameters. Additionally, the investigators will examine whether patients with HF experience a more rapid reduction in subcortical volumes compared to those with normal cardiac function (EF;50%).

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 data supports the effectiveness of MRI as a treatment for heart failure?

MRI is a powerful tool for assessing heart function and structure in heart failure patients. It helps doctors understand the cause of heart failure and guides treatment decisions by accurately measuring heart function and identifying heart tissue changes. ^{1 2 3 4 5}

Is MRI safe for heart failure patients?

MRI, when using gadolinium-based contrast agents, has been studied for safety in heart imaging. Research shows that these agents are generally safe, with some risk of mild adverse reactions. It's important to discuss any concerns with your doctor, especially if you have kidney issues, as they can affect how your body handles these agents. ^{6 7 8 9 10}

How does MRI differ from other treatments for heart failure?

MRI for heart failure is unique because it is a non-invasive imaging technique that provides detailed pictures of the heart's structure and function, unlike traditional treatments that may involve medication or surgery. It can be particularly useful for patients with complex heart conditions or those who cannot undergo other imaging methods due to body size or metal implants. ^{1 11 12 13 14}

Research Team

Joao AC Lima, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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 have given my informed consent.

I am not claustrophobic.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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 (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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cardiac MRI at Low Field Strengths. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The Role of Cardiovascular Magnetic Resonance Imaging in Heart Failure. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Serial assessment of ventricular morphology and function. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular Magnetic Resonance in Valvular Heart Disease-Related Heart Failure. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance and the evaluation of heart failure. [2019]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of gadoversetamide in patients with acute and chronic myocardial infarction. [2017]

8. United States 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. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of regadenoson CMR. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Cardiac magnetic resonance imaging in valvular heart disease. [2009]

12. Germany pubmed.ncbi.nlm.nih.gov

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

13. England pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance feature tracking in small animals - a preliminary study on reproducibility and sample size calculation. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Imaging Adults With Congenital Heart Disease Part II: Advanced CMR Techniques. [2018]