Recruiting

Myocardial Stiffness

Sponsor:

Mayo Clinic

Code:

NCT07216469

Conditions

Amyloidosis

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Interventions

Magnetic Resonance Elastography (MRE)

Study Details

Brief summary:

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.

Conditions

Amyloidosis

Study ID

NCT07216469

Start date

Oct 14, 2025

Status verified date

Dec, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Inclusion Criteria

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

1. Adult, age 20 and greater
2. Subject is clinically stable without cardiovascular-related hospitalizations within 2 weeks prior to enrollment as assessed by the investigators
3. Subject is able to provide written informed consent and is willing and able to complete study procedures
4. 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:

1\. 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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Cardiac Amyloidosis

Interventions

Magnetic Resonance Elastography (MRE)

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

Primary outcome measure

  • Percentage of subjects able to complete a Magnetic Resonance Elastography exam [ Time Frame: Baseline ]
  • Mean Myocardial Stiffness [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Ian C Chang, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-12-26.