~67 spots leftby Oct 2026

MRI for Heart Failure

Recruiting in Palo Alto (17 mi)
+1 other location
JA
Overseen byJoao AC Lima, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Pregnancy, Metal fragments, others
No Placebo Group
Approved in 2 Jurisdictions

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.12345

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.678910

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.111121314

Research Team

JA

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.
See 2 more

Trial 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 (Procedure)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Group I: Non-HospitalizedExperimental Treatment1 Intervention
Participants who had heart failure (HF) but did not require hospitalization secondary to the illness.
Group II: HospitalizedExperimental Treatment1 Intervention
Participants who were hospitalized due to heart failure (HF) illness.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Johns Hopkins Center for Advanced Imaging and Research Science, Johns Hopkins Science + Technology Park at 1812 Ashland Avenue, Baltimore, MDBaltimore, MD
Johns Hopkins HospitalBaltimore, MD
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Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2366
Patients Recruited
15,160,000+

Canon Medical Systems, USA

Industry Sponsor

Trials
14
Patients Recruited
1,300+

Findings from Research

Cardiac MRI at Low Field Strengths.Campbell-Washburn, AE., Varghese, J., Nayak, KS., et al.[2023]
The Role of Cardiovascular Magnetic Resonance Imaging in Heart Failure.Peterzan, MA., Rider, OJ., Anderson, LJ.[2021]
Serial assessment of ventricular morphology and function.Grothues, F., Braun-Dullaeus, R.[2009]
Cardiovascular Magnetic Resonance in Valvular Heart Disease-Related Heart Failure.Uretsky, S., Wolff, SD.[2021]
Cardiovascular magnetic resonance and the evaluation of heart failure.Moon, JC., Prasad, SK.[2019]
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]
Safety of gadoversetamide in patients with acute and chronic myocardial infarction.Huber, S., Muthupillai, R., Cheong, B., et al.[2017]
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.
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]
Safety and tolerability of regadenoson CMR.Nguyen, KL., Bandettini, WP., Shanbhag, S., et al.[2021]
Cardiac magnetic resonance imaging in valvular heart disease.Koskenvuo, JW., Järvinen, V., Pärkkä, JP., et al.[2009]
[Acceleration of cardiovascular MRI using parallel imaging: basic principles, practical considerations, clinical applications and future directions].Niendorf, T., Sodickson, D.[2006]
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]
Imaging Adults With Congenital Heart Disease Part II: Advanced CMR Techniques.Sahu, A., Slesnick, TC.[2018]

References

Cardiac MRI at Low Field Strengths. [2023]
The Role of Cardiovascular Magnetic Resonance Imaging in Heart Failure. [2021]
Serial assessment of ventricular morphology and function. [2009]
Cardiovascular Magnetic Resonance in Valvular Heart Disease-Related Heart Failure. [2021]
Cardiovascular magnetic resonance and the evaluation of heart failure. [2019]
Gadolinium-based Contrast Agents for Cardiac MRI: Use of Linear and Macrocyclic Agents with Associated Safety Profile from 154 779 European Patients. [2022]
Safety of gadoversetamide in patients with acute and chronic myocardial infarction. [2017]
Acute adverse reactions to gadolinium-based contrast agents in CMR: multicenter experience with 17,767 patients from the EuroCMR Registry. [2016]
What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent. [2023]
Safety and tolerability of regadenoson CMR. [2021]
Cardiac magnetic resonance imaging in valvular heart disease. [2009]
[Acceleration of cardiovascular MRI using parallel imaging: basic principles, practical considerations, clinical applications and future directions]. [2006]
Cardiovascular magnetic resonance feature tracking in small animals - a preliminary study on reproducibility and sample size calculation. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
Imaging Adults With Congenital Heart Disease Part II: Advanced CMR Techniques. [2018]