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NCT Number: NCT07216469

A Study Of Myocardial Stiffness In Amyloidosis With Magnetic Resonance Elastography

This is a prospective case control study to determine the feasibility and utility of myocardial stiffness assessment by cardiac magnetic resonance elastography (MRE) in patients with cardiac amyloidosis.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Ian C Chang, MD

PRINCIPAL_INVESTIGATOR

Kathy Brown

CONTACT

[email protected]

507-538-1321

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects are eligible to be included in the study if all the following criteria apply:

  • Adult, age 20 and greater
  • Subject is clinically stable without cardiovascular-related hospitalizations within 2 weeks prior to enrollment as assessed by the investigators
  • Subject is able to provide written informed consent and is willing and able to complete study procedures
  • Subject must meet criteria for either ATTR cardiac amyloidosis or AL cardiac amyloidosis from review of medical records as specified below:

a. ATTR cardiac amyloidosis based on meeting all the following criteria:

i. Diagnosis of amyloidosis within ten years prior to study screening

ii. Transthyretin amyloid deposits in cardiac tissue OR Technetium (99mTc) bone scintigraphy with grade 2 or 3 cardiac uptake OR Transthyretin amyloid deposits in non-cardiac tissue with echocardiographic evidence of cardiac involvement or an end-diastolic mean wall thickness > 12 mm OR Transthyretin amyloid deposits in non-cardiac tissue with cardiac MRI diagnostic of amyloidosis OR Clinical diagnosis of cardiac amyloidosis by the clinical provider

b. AL cardiac amyloidosis based on meeting all the following criteria:

i. Diagnosis of amyloidosis within ten years prior to study screening

ii. Histopathologic diagnosis of amyloidosis with AL protein identification

iii. Cardiac involvement as defined by: Amyloid deposits in cardiac deposits OR Echocardiography with an end-diastolic mean wall thickness > 12 mm in the absence of other causes OR Elevated NT-proBNP (>332 ng/L) in the absence of renal failure or atrial fibrillation OR Cardiac MRI diagnostic of amyloidosis OR Clinical diagnosis of cardiac amyloidosis by the clinical provider

Exclusion criteria

Patients are ineligible to be included in the study if any of the following criteria apply:

  • Unable to consent or unable to complete all study procedures 2. Unable to ambulate for 6 minutes (confirmed at study coordinator visit) 3. Unable to maintain in supine position for 30 minutes 4. Unable to maintain breath-holding for 10 seconds (confirmed at study coordinator visit) 5. Contraindications for safe MRI scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator) 6. Presence of implantable cardiac pacemaker or defibrillator 7. History of complex congenital heart disease, prosthetic valves, prosthesis in the main pulmonary artery or ascending thoracic aorta 8. Significant artifact from prior MRI studies 9. Pregnant or breast-feeding women 10. Weight equal to or greater than 155 kg 11. In the judgment of the investigator, has clinically relevant ongoing medical condition or laboratory abnormalities or other condition that might jeopardize the participants safety, increase the participants risk from participation, interfere with the study, or confirmed study results

Treatment and study plan

Magnetic Resonance Elastography (MRE)

Diagnostic Test

Patients will undergo a cardiac MRI with the addition of continuous free-breathing and breath-held MRE sequences.

Primary outcomes

  1. Percentage of subjects able to complete a Magnetic Resonance Elastography exam

    Time frame: Baseline

    Magnetic Resonance Elastography exam completion will be determined by signal to noise (SNR) ratio

  2. Mean Myocardial Stiffness

    Time frame: Baseline

    Mean Myocardial stiffness will be measured by magnetic resonance elastography during early systole, end systole, early diastole and end diastole (kPa).

Study contacts

Contact information is provided by the study sponsor or research team.

Kathy Brown

CONTACT

[email protected]

507-538-8274

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Myocardial Stiffness in Amyloidosis by Magnetic Resonance Elastography - AMREloid Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 14, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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