Screening for Cardiac Amyloidosis with Nuclear Cardiology for Minority Populations

Status: Active_not_recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

In this study, the investigators will recruit a cohort of elderly Black and Hispanic patients with heart failure to define the number of patients who have cardiac amyloidosis by utilizing highly sensitive heart imaging and blood tests. The investigators will also explore differences in genetics and sex as they relate to heart failure disease progression in cardiac amyloidosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Black or Hispanic of Caribbean origin.

• Age ≥ 60 years.

• Diagnosis of heart failure, confirmed by one of two methods:

‣ Modified criteria utilized by Rich et al. which include a history of acute pulmonary edema or the occurrence of at least two of the following that improved with diuretic therapy without another identifiable cause: dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, bilateral lower extremity edema or exertional fatigue, and

⁃ National Health and Nutrition Examination Survey (NHANES) congestive heart failure (CHF) criteria with a score ≥3.

• Left ventricular septal OR inferolateral wall thickness ≥12 mm by echocardiography.

• Left ventricular Ejection fraction \>30% by echocardiography.

• Able to understand and sign the informed consent document after the nature of the study has been fully explained.

Locations
United States
Connecticut
Yale University/Yale New Haven Medical Center
New Haven
Massachusetts
Boston Medical Center/Boston University Medical Center
Boston
New York
Columbia University Irving Medical Center
New York
Harlem Hospital
New York
Time Frame
Start Date: 2019-05-15
Completion Date: 2025-04-30
Participants
Target number of participants: 650
Treatments
Blacks/Hispanics with Heart Failure
Blacks/Hispanics with heart failure due to transthyretin cardiac amyloidosis will be identified by 99mTc-PYP (or 99mTc-HDP) scintigraphy. Those with transthyretin cardiac amyloidosis will be further subtyped into those with a genetic cause (ATTRm) and those with a non-genetic cause (ATTRwt - wild type transthyretin cardiac amyloidosis).
Sponsors
Collaborators: Yale University, Boston Medical Center, The Scripps Research Institute, Harlem Hospital Center, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Mathew S. Maurer, MD

This content was sourced from clinicaltrials.gov