Advanced Imaging Techniques for Cardiomyopathy (MICA Trial)

Recruiting in Palo Alto (17 mi)

Overseen BySharmila Dorbala, MBBS, MPH

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brigham and Women's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?Cardiac amyloidosis is a major cause of early treatment-related death and poor overall survival in individuals with systemic light chain amyloidosis. This project will develop a novel approach to visualize cardiac amyloid deposits using advanced imaging methods. The long-term goal of this work is to identify the mechanisms of cardiac dysfunction, in order to guide the development of novel life-saving treatments.

Eligibility Criteria

Adults diagnosed with light chain amyloidosis or heart failure without amyloidosis, able to exercise and consent. Excludes those with severe coronary artery disease, claustrophobia that sedatives can't help, pregnancy, significant kidney dysfunction, certain metallic implants (except MR compatible devices for control subjects), on dialysis, unable to attend follow-up visits or lie flat for an hour.

Inclusion Criteria

I have been diagnosed with heart failure, not caused by amyloidosis.

I can do exercises on a bike while lying on my back.

I have been diagnosed with light chain amyloidosis through specific tests.

I have been diagnosed with multiple myeloma and do not have amyloidosis.

I am older than 18 years.

My blood cancer has been responding well to treatment for over a year.

Exclusion Criteria

I have a significant blockage in a heart artery.

I cannot lie flat for an hour due to heart failure.

My blood pressure and heart rate are stable.

I cannot exercise or return for PET/CT scans at the required times.

I have heart disease that is not caused by blocked arteries or amyloid.

I experience severe claustrophobia even with sedatives.

I am allergic to F-18 florbetapir, C-11 acetate, or gadolinium.

I am not on dialysis.

My kidney function is significantly impaired with an eGFR less than 30.

Participant Groups

The trial is testing advanced imaging methods like F-18 florbetapir/C-11 acetate PET scans and MRI to visualize cardiac amyloid deposits in patients with cardiac amyloidosis. The goal is to understand the mechanisms of cardiac dysfunction better.

5Treatment groups

Experimental Treatment

Active Control

Group I: Heart FailureExperimental Treatment2 Interventions

10 individuals with diagnosis of heart failure without amyloidosis by standard criteria will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI of the heart, as well as a heavy metal analysis of the blood at baseline..

Group II: Active AL cardiac amyloidosisExperimental Treatment3 Interventions

75 individuals with light chain systemic amyloidosis with active plasma cell dyscrasia and cardiac involvement will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI of blood of the heart, as well as the heavy metal analysis of the blood at baseline, 6 months and 12 months after initiation of chemotherapy. 25 of these individuals will also undergo a N-13 ammonia PET scan of the heart following supine bicycle stress at baseline and at 6 months after initiation of chemotherapy.

Group III: Active AL Pre-CMPExperimental Treatment2 Interventions

36 individuals with light chain systemic amyloidosis with active plasma cell dyscrasia and without cardiac involvement will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI of the heart, as well as a heavy metal analysis of the blood at baseline. At 6 months they will undergo a research MRI of the heart and at 12 months they will have a clinical follow up. Subjects with contraindications to Cardiac MRI or gadolinium contrast may still be eligible for study participation.

Group IV: Multiple Myeloma ControlsActive Control1 Intervention

25 individuals with diagnosis of multiple myeloma without concomitant amyloidosis by standard criteria will undergo urine and blood testing only.

Group V: Remission AL cardiac amyloidosisActive Control2 Interventions

25 individuals with light chain systemic amyloidosis with cardiac involvement and plasma cell dyscrasia in hematological remission (complete hematological remission or very good partial response-differential free light chain (dFLC)\<40 mg/dL for \> 1 year prior to enrollment) will undergo a research F-18 florbetapir PET, C-11 acetate PET, and MRI scan of the heart as well as a heavy metal analysis of the blood at baseline.