RecruitingNot Applicable

Molecular Imaging of Primary Amyloid Cardiomyopathy

United States171 participantsStarted 2016-04-01

Plain-language summary

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.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Age \> 18 years * Diagnosis of light chain amyloidosis by standard criteria (immunofixation of serum and urine, IgG free light chain (FLC) assay, a biopsy of fat pad/ bone marrow, or organ biopsy, followed by typing of the light chain using immunohistochemistry or immunogold assay with confirmation by Mass spectroscopy as needed) * For subjects traveling from out of town referred for systemic AL therapy based on clinical evaluation and laboratory testing, but, pending biopsy results, study enrollment and procedures may begin before official confirmation of biopsy results. If biopsy is negative for AL amyloidosis, subject will be considered a screen failure. There will be no more than 10 subjects who fall under this screen failure for the duration of the study. * Subjects with localized amyloid deposition and non-systemic AL disease will be eligible for enrollment in group D. * Willing and able to provide consent * Additional inclusion criteria for the Remission AL-CMP: Hematological response defined as complete hematological remission or very good partial response-differential free light chain (dFLC)\<40 mg/dL for \> 1 year prior to enrollment * Additional inclusion criteria for the Active AL-CMP - exercise: Ability to perform supine bicycle exercise. Enrollment to this arm will stop after 36 subjects complete baseline and 6 months studies. * Additional inclusion criteria for the Active AL Pre-CMP - Normal left ventricular wall thickness (≤ 12 mm) …

What they're measuring

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

Timeframe: Baseline, 6 and 12 months

Change in Serum oxidative stress markers from baseline to 6 months and 12 months

Timeframe: Baseline, 6 and 12 months

Change in Myocardial oxidative metabolism markers from baseline to 6 months

Timeframe: Baseline and 6 months

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

Timeframe: Baseline, 6 and 12 months

Trial details

NCT IDNCT02641145

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Sharmila Dorbala, MD, MPH

617-732-6290 sdorbala@partners.org

View on ClinicalTrials.gov More Amyloidosis, Primary trials

Plain-language summary

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Baseline, 6 and 12 months

Change in Serum oxidative stress markers from baseline to 6 months and 12 months

Timeframe: Baseline, 6 and 12 months

Change in Myocardial oxidative metabolism markers from baseline to 6 months

Timeframe: Baseline and 6 months

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

Timeframe: Baseline, 6 and 12 months