Research Study for Patients with Cardiac Amyloids

Study Summary

The University of Chicago and Dr. Antony Kim are conducting a research study to gather information about the diseases Familial Amyloid Cardiomyopathy (FAC) and Senile Systemic Amyloidosis (SSA). Both FAC and SSA are caused by the presence of amyloids in the heart area (cardiac amyloids). Cardiac amyloids occur when particular proteins accumulate and/or clump outside of the cell, within the tissues of the heart. FAC and SSA both affect the heart, leading to impaired functioning. These diseases look very similar and in fact, it is hard to distinguish between them without very specific laboratory testing. For this study, we are looking at them separately in order to better understand the possibility of future treatments. The goal of this study is to learn more about FAC and SSA to provide more information to doctors and patients with the disease. This investigation does not involve a study drug given or provided by the sponsor pharmaceutical company but is instead a study of medical information gathered from patients.

Your participation in this study will be about two years. Some of the procedures that may be done during the study include genetic testing pertaining to cardiac amyloids, analysis of your amyloid biopsy sample, physical exams, blood tests, urine tests, echocardiogram (test that uses sound waves to form an image of your heart), electrocardiogram (test that measures the electrical activity of your heart), walk test (a measure of your tolerance for light exercise), heart MRI (a test that produces very high quality images of the heart), questionnaires, and follow-up telephone calls.

You may receive a total of $200 in financial compensation for your transportation costs associated with study visits to the clinic. Upon completing each full study visit, you will receive $40. There are five clinic visits associated with this study.

Benefits

You may not benefit directly from this research. This is the first study of its kind to learn more information about FAC and SSA in a large group of patients. The information gathered in this study could lead to better monitoring and treatment options for you and/or other patients diagnosed with this condition.

Participation Details

Initial selection criteria include:

• Must be age 18 years or older
• Must have a history of Familial Amyloid Cardiomyopathy (FAC) or Senile Systemic Amyloidosis (SSA)
• Must be available for clinic visits for the duration of the study
• Must meet study medical criteria as evaluated by Dr. Kim

Study Director: Dr. Antony Kim
Department: Cardiology

For more information contact:
lbond@medicine.bsd.uchicago.edu
(773) 702-6385

IRB: #13975A