Phase
Condition
Amyloidosis
Treatment
Six-minute Walk Test
Cardiac magnetic resonance image (CMR)
Transthoracic Echocardiogram (TTE)
Clinical Study ID
Ages > 40 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 tocomplete study procedures.
Currently in sinus rhythm by clinical assessment or documented electrocardiographicstudies.
Subject and disease characteristics noted by medical record review:
Healthy control volunteers must also meet the following criteria: Karnofskyperformance scale > 80%; ECOG status 0 or 1.
ATTR cardiac amyloidosis based on meeting all the following criteria: Diagnosisof amyloidosis within five years prior to study screening; Documentation ofabsence of AL, heavy chain disease, multiple myeloma or malignantlymphoproliferative disorders; Transthyretin amyloid deposits in cardiac tissueOR technetium (99mTc) pyrophosphate scintigraphy with grade 2 or 3 cardiacuptake OR Transthyretin amyloid deposits in non-cardiac tissue withechocardiographic evidence of cardiac involvement or an end-diastolic mean wallthickness >12mm OR Transthyretin amyloid deposits in non-cardiac tissue withCMR 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; Cardiacinvolvement as defined by: Amyloid deposits in cardiac deposits OREchocardiography with an end-diastolic mean wall thickness > 12 mm in theabsence of other causes OR Elevated NT-proBNP (>332 ng/L) in the absence ofrenal 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; Nodocumented clinical signs and symptoms consistent with heart failure from AL;Absence of cardiac involvement as defined by: Echocardiography with anend-diastolic mean wall thickness < 13 mm if the subject does not have othercauses for increased wall thickness AND NT-proBNP <333 ng/L if the subject doesnot have renal failure or atrial fibrillation AND No CMR diagnostic ofamyloidosis if CMR is available prior to screening.
Exclusion
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 coordinatorvisit).
Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlearimplant, implanted neural stimulator).
Presence of implantable cardiac pacemaker or defibrillator.
History of complex congenital heart disease, intracardiac shunt (except for patentforamen ovale), prosthetic valves, prosthesis in the main pulmonary artery orascending 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 70cm.
Documented non-sinus rhythm within 1 week prior to screening.
For healthy controls, the following exclusion criteria apply, confirmed per chartreview 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, ventriculartachyarrhythmia, or bradyarrhythmia;
Left ventricular hypertrophy or abnormally increased myocardial thickness byprior 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 diastolicblood 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 A1cgreater than 8, as per medical record review;
Taking three or more diabetic medications;
History of confirmed stroke or transient ischemic attack, as per medical recordreview;
Current cigarette smoker;
History of plasma cell dyscrasia or chronic malignant hematologic diagnosis;
BMI > 35 kg/m^2.
Study Design
Connect with a study center
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
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