Amyloidosis CardiacNCT05379101
Intracardiac Flow Assessment in Cardiac Amyloidosis
An observational study of Amyloidosis Cardiac and Healthy Adults, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary objective of this study is to define the intracardiac flow imaging biomarkers in cardiac amyloidosis. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyloidosis Cardiac, Healthy Adults
- What is being tested?
- Cardiac magnetic resonance image (CMR), Transthoracic Echocardiogram (TTE) and Six-minute Walk Test
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2022to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with amyloidosis without and with cardiac involvement, and normal healthy volunteers
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to define the intracardiac flow imaging biomarkers in cardiac amyloidosis.
- Conditions
- Amyloidosis Cardiac, Healthy Adults
- Being tested
- Cardiac magnetic resonance image (CMR), Transthoracic Echocardiogram (TTE), Six-minute Walk Test
- Medical subject headings
- Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance image (CMR)Diagnostic test
A magnetic resonance imaging study for assessment of cardiac structure and intracardiac flow
Transthoracic Echocardiogram (TTE)Diagnostic test
An imaging test that uses soundwaves that cannot be heard (ultrasound) to take pictures of the heart and vessels.
Six-minute Walk TestDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Transthyretin (ATTR) cardiac amyloidosis | Subjects diagnosed with ATTR cardiac amyloidosis will have CMR, TTE, and 6-minute walk Receives: 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: Cardiac magnetic resonance image (CMR); Diagnostic Test: Transthoracic Echocardiogram (TTE); Diagnostic Test: Six-minute Walk Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the intracardiac flow imaging biomarkers in cardiac amyloidosis (CA)
Measured by cardiac magnetic resonance imaging (CMR)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start20 Jul 2022
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloidosis CardiacStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian C. Chang, Mayo Clinic
- Investigators
- Ian C Chang, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379101
- Sponsor's protocol ID
- 22-001098
- Status last verified
- Jun 2026
- First submitted
- 13 May 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracardiac Flow Assessment in Cardiac Amyloidosis
- ClinicalTrials.gov ID
- NCT05379101
- Acronym / sponsor ID
- 22-001098
- Conditions
- Amyloidosis Cardiac, Healthy Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to define the intracardiac flow imaging biomarkers in cardiac amyloidosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transthyretin (ATTR) cardiac amyloidosis | – | Diagnostic Test: Cardiac magnetic resonance image (CMR), Diagnostic Test: Transthoracic Echocardiogram (TTE), Diagnostic Test: Six-minute Walk TestSubjects diagnosed with ATTR cardiac amyloidosis will have CMR, TTE, and 6-minute walk |
| Light chain amyloidosis (AL) with cardiac involvement | – | Diagnostic Test: Cardiac magnetic resonance image (CMR), Diagnostic Test: Transthoracic Echocardiogram (TTE), Diagnostic Test: Six-minute Walk TestSubjects diagnosed with AL with cardiac involvement will have CMR, TTE, and 6-minute walk |
| Light chain amyloidosis (AL) without cardiac involvement | – | Diagnostic Test: Cardiac magnetic resonance image (CMR), Diagnostic Test: Transthoracic Echocardiogram (TTE), Diagnostic Test: Six-minute Walk TestSubjects diagnosed with AL without cardiac involvement will have CMR, TTE, and 6-minute walk |
| Healthy Control | – | Diagnostic Test: Cardiac magnetic resonance image (CMR), Diagnostic Test: Transthoracic Echocardiogram (TTE), Diagnostic Test: Six-minute Walk TestSubjects without history of cardiovascular diseases will have CMR, TTE, and 6-minute walk |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with amyloidosis without and with cardiac involvement, and normal healthy volunteers
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (28 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac magnetic resonance image (CMR)A magnetic resonance imaging study for assessment of cardiac structure and intracardiac flow | Diagnostic test | Healthy Control, Light chain amyloidosis (AL) with cardiac involvement, Light chain amyloidosis (AL) without cardiac involvement, Transthyretin (ATTR) cardiac amyloidosis |
| Transthoracic Echocardiogram (TTE)An imaging test that uses soundwaves that cannot be heard (ultrasound) to take pictures of the heart and vessels. | Diagnostic test | Healthy Control, Light chain amyloidosis (AL) with cardiac involvement, Light chain amyloidosis (AL) without cardiac involvement, Transthyretin (ATTR) cardiac amyloidosis |
| Six-minute Walk TestA 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 | Diagnostic test | Healthy Control, Light chain amyloidosis (AL) with cardiac involvement, Light chain amyloidosis (AL) without cardiac involvement, Transthyretin (ATTR) cardiac amyloidosis |
Primary outcome
Define the intracardiac flow imaging biomarkers in cardiac amyloidosis (CA)
Time frame: Baseline
Measured by cardiac magnetic resonance imaging (CMR)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian C Chang, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloidosis Cardiac and Healthy Adults, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the intracardiac flow imaging biomarkers in cardiac amyloidosis (CA) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.