Intracardiac Flow Assessment in Cardiac Amyloidosis

The primary objective of this study is to define the intracardiac flow imaging biomarkers in cardiac amyloidosis.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adults; Amyloidosis Cardiac
• Intervention / Treatment: Diagnostic test: Cardiac magnetic resonance image (CMR); Diagnostic test: Transthoracic Echocardiogram (TTE); Diagnostic test: Six-minute Walk Test

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Kathy Brown; Phone Number: 507-538-1321; Email: brown.kathy@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Ian C Chang, MD
      • Sub-Investigator: Christopher Francois, MD
      • Contact: Kathy Brown; Phone Number: 507-538-1321; Email: brown.kathy@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with amyloidosis without and with cardiac involvement, and normal healthy volunteers

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transthyretin (ATTR) cardiac amyloidosis; Subjects diagnosed with ATTR cardiac amyloidosis will have CMR, TTE, and 6-minute walk	Diagnostic test: Cardiac magnetic resonance image (CMR); A magnetic resonance imaging study for assessment of cardiac structure and intracardiac flow; Diagnostic test: Transthoracic Echocardiogram (TTE); An imaging test that uses soundwaves that cannot be heard (ultrasound) to take pictures of the heart and vessels.; Diagnostic test: Six-minute Walk Test; A self-paced, test of exercise capacity performed unencouraged intensity that measures the distance that patients can walk on a flat, hard surface in a period of 6 minutes
Light chain amyloidosis (AL) with cardiac involvement; Subjects diagnosed with AL with cardiac involvement will have CMR, TTE, and 6-minute walk	Diagnostic test: Cardiac magnetic resonance image (CMR); A magnetic resonance imaging study for assessment of cardiac structure and intracardiac flow; Diagnostic test: Transthoracic Echocardiogram (TTE); An imaging test that uses soundwaves that cannot be heard (ultrasound) to take pictures of the heart and vessels.; Diagnostic test: Six-minute Walk Test; A self-paced, test of exercise capacity performed unencouraged intensity that measures the distance that patients can walk on a flat, hard surface in a period of 6 minutes
Light chain amyloidosis (AL) without cardiac involvement; Subjects diagnosed with AL without cardiac involvement will have CMR, TTE, and 6-minute walk	Diagnostic test: Cardiac magnetic resonance image (CMR); A magnetic resonance imaging study for assessment of cardiac structure and intracardiac flow; Diagnostic test: Transthoracic Echocardiogram (TTE); An imaging test that uses soundwaves that cannot be heard (ultrasound) to take pictures of the heart and vessels.; Diagnostic test: Six-minute Walk Test; A self-paced, test of exercise capacity performed unencouraged intensity that measures the distance that patients can walk on a flat, hard surface in a period of 6 minutes
Healthy Control; Subjects without history of cardiovascular diseases will have CMR, TTE, and 6-minute walk	Diagnostic test: Cardiac magnetic resonance image (CMR); A magnetic resonance imaging study for assessment of cardiac structure and intracardiac flow; Diagnostic test: Transthoracic Echocardiogram (TTE); An imaging test that uses soundwaves that cannot be heard (ultrasound) to take pictures of the heart and vessels.; Diagnostic test: Six-minute Walk Test; A self-paced, test of exercise capacity performed unencouraged intensity that measures the distance that patients can walk on a flat, hard surface in a period of 6 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Define the intracardiac flow imaging biomarkers in cardiac amyloidosis (CA)	Measured by cardiac magnetic resonance imaging (CMR)	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ian C Chang, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID Numbers: 22-001098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No