Heart imaging may reveal hidden clues in rare heart disease
NCT ID NCT05379101
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This study uses advanced heart imaging to understand how blood flows inside the heart in people with cardiac amyloidosis, a condition where abnormal proteins build up in heart tissue. Researchers will compare these images with those from healthy volunteers to find unique patterns, or biomarkers, that could help diagnose or track the disease. Participants will undergo MRI scans, echocardiograms, and a six-minute walk test.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could identify new imaging markers to help diagnose or monitor cardiac amyloidosis more accurately.
- What could go wrong
- This is an observational study, not a treatment trial. It may not lead to direct patient benefits or change clinical practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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81 people
The number who actually took part.
- Started
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Jul 2022
- Finished
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May 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with amyloidosis without and with cardiac involvement, and normal healthy volunteers
- Ages
-
40 years and older
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subject is clinically stable without cardio-vascular-related hospitalizations within 6 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. * Currently in sinus rhythm by clinical assessment or documented electrocardiographic studies. * Subject and disease characteristics noted by medical record review: * Healthy control volunteers must also meet the following criteria: Karnofsky performance scale \> 80%; ECOG status 0 or 1. * ATTR cardiac amyloidosis based on meeting all the following criteria: Diagnosis of amyloidosis within five years prior to study screening; Documentation of absence of AL, heavy chain disease, multiple myeloma or malignant lymphoproliferative disorders; Transthyretin amyloid deposits in cardiac tissue OR technetium (99mTc) pyrophosphate 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 \>12mm OR Transthyretin amyloid deposits in non-cardiac tissue with CMR diagnostic of amyloidosis * AL with cardiac involvement based on meeting all the following criteria: Diagnosis of amyloidosis within five years prior to study screening; Histopathologic diagnosis of amyloidosis with AL protein identification; Documented clinical signs or symptoms consistent with heart failure; 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 CMR diagnostic of amyloidosis; * AL without cardiac involvement based on meeting all the following criteria: Diagnosis of amyloidosis within five years prior to study screening; Histopathologic diagnosis of amyloidosis with AL protein identification; No documented clinical signs and symptoms consistent with heart failure from AL; Absence of cardiac involvement as defined by: Echocardiography with an end-diastolic mean wall thickness \< 13 mm if the subject does not have other causes for increased wall thickness AND NT-proBNP \<333 ng/L if the subject does not have renal failure or atrial fibrillation AND No CMR diagnostic of amyloidosis if CMR is available prior to screening. Exclusion Criteria: * Unable to consent or unable to complete all study procedures. * Unable to ambulate for 6 minutes (confirmed at study coordinator visit). * Unable to maintain in supine position for 30 minutes. * Unable to maintain breath-holding for 10 seconds (confirmed at study coordinator visit). * Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator). * Presence of implantable cardiac pacemaker or defibrillator. * History of complex congenital heart disease, intracardiac shunt (except for patent foramen ovale), prosthetic valves, prosthesis in the main pulmonary artery or ascending thoracic aorta. * Significant artifact from prior MRI studies. * Pregnant or breast-feeding women. * Weight equal to or greater than 155 kg. * Maximum body side-to-side or anterior-posterior diameter equal to or greater than 70 cm. * Documented non-sinus rhythm within 1 week prior to screening. * For healthy controls, the following exclusion criteria apply, confirmed per chart review and/or patient report: * History of cardiomyopathy or structural heart disease; * History of valvular disease of greater than mild severity; * History of coronary artery disease or coronary heart disease; * History of cardiac or thoracic surgery. * History of symptomatic, persistent atrial tachyarrhythmia, ventricular tachyarrhythmia, or bradyarrhythmia; * Left ventricular hypertrophy or abnormally increased myocardial thickness by prior echocardiography, cardiac computed tomography, or CMR; * Acute kidney injury, OR chronic renal disease with glomerular filtration rate \< 45 mL/min/1.73m\^2 as per medical record review. * Uncontrolled hypertension of systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg as per medical record review; * Taking three or more anti-hypertensive medications; * Type 1 diabetes, OR uncontrolled type 2 diabetes mellitus of hemoglobin A1c greater than 8, as per medical record review; * Taking three or more diabetic medications; * History of confirmed stroke or transient ischemic attack, as per medical record review; * Current cigarette smoker; * History of plasma cell dyscrasia or chronic malignant hematologic diagnosis; * BMI \> 35 kg/m\^2.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Other studies related to the condition(s) this trial covers.
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