Intracardiac Flow Assessment in Cardiac Amyloidosis

NCT05379101 | Recruiting

• 1 other identifier: 22-001098
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amyloidosis Cardiac; Healthy Adults

Outcome Measures

Primary Outcomes (1)

• Define the intracardiac flow imaging biomarkers in cardiac amyloidosis (CA)

  Measured by cardiac magnetic resonance imaging (CMR)

  Baseline

Study Arms (4)

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); Diagnostic Test: Transthoracic Echocardiogram (TTE); Diagnostic Test: Six-minute Walk Test

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); Diagnostic Test: Transthoracic Echocardiogram (TTE); Diagnostic Test: Six-minute Walk Test

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); Diagnostic Test: Transthoracic Echocardiogram (TTE); Diagnostic Test: Six-minute Walk Test

Healthy Control

Subjects without history of cardiovascular diseases will have CMR, TTE, and 6-minute walk

Diagnostic Test: Cardiac magnetic resonance image (CMR); Diagnostic Test: Transthoracic Echocardiogram (TTE); Diagnostic Test: Six-minute Walk Test

Interventions

Cardiac magnetic resonance image (CMR) DIAGNOSTIC_TEST

A magnetic resonance imaging study for assessment of cardiac structure and intracardiac flow

Healthy Control; Light chain amyloidosis (AL) with cardiac involvement; Light chain amyloidosis (AL) without cardiac involvement; Transthyretin (ATTR) cardiac amyloidosis

Transthoracic Echocardiogram (TTE) DIAGNOSTIC_TEST

An imaging test that uses soundwaves that cannot be heard (ultrasound) to take pictures of the heart and vessels.

Healthy Control; Light chain amyloidosis (AL) with cardiac involvement; Light chain amyloidosis (AL) without cardiac involvement; Transthyretin (ATTR) cardiac amyloidosis

Six-minute Walk Test DIAGNOSTIC_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; Light chain amyloidosis (AL) with cardiac involvement; Light chain amyloidosis (AL) without cardiac involvement; Transthyretin (ATTR) cardiac amyloidosis

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Interventions

Echocardiography; Walk Test

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Exercise Test

Study Officials

• Ian C Chang, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Brown

CONTACT

507-538-1321; brown.kathy@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: July 20, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)