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Advanced Imaging Techniques for Cardiomyopathy (MICA Trial)

N/A

Recruiting

Led By Sharmila Dorbala, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of heart failure without amyloidosis by standard criteria

Ability to perform supine bicycle exercise. Enrollment to this arm will stop after 36 subjects complete baseline and 6 months studies.

Must not have

Known obstructive epicardial coronary artery disease with stenosis > 50% in any single territory

Decompensated heart failure (unable to lie flat for 1 hour)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will use advanced imaging to visualize deposits of a heart disease, to develop treatments and save lives. #medicalresearch

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to the imaging agents used (F-18 florbetapir/C-11 acetate) such as allergic reactions. Gadolinium contrast used in MRI might cause issues if there's severe kidney dysfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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

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I am older than 18 years.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a significant blockage in a heart artery.

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

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My blood pressure and heart rate are stable.

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

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

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I experience severe claustrophobia even with sedatives.

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

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I am not on dialysis.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in F-18 florbetapir myocardial retention index from baseline to 6 months and 12 months

Change in Magnetic resonance imaging markers from baseline to 6 months and 12 months

Change in Myocardial oxidative metabolism markers from baseline to 6 months

+1 more

Secondary study objectives

Change in Myocardial energy efficiency from baseline to 6 months

Light Chain Toxicity

Understand the role of gut microbiota and heavy metals in the pathogenesis of AL Amyloidosis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRI

2009

Completed Phase 2

~2810

0 / 15Eligibility criteria met