Global Prevalence of ATTR-CM in Participants With HFpEF

Study Overview
=================
Brief Summary
-----------------
This study is a global, multi-center study designed to estimate the global prevalence of transthyretin amyloid cardiomyopathy (ATTR-CM) within a clinically at risk population [participants with heart failure with preserved ejection fraction (HFpEF)].

Official Title
-----------------
GLOBAL PREVALENCE OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF)

Conditions
-----------------
Transthyretin Amyloid Cardiomyopathy, Heart Failure With Preserved Ejection Fraction

Intervention / Treatment
-----------------
* Diagnostic Test: Scintigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical history of heart failure (HF) with: At least 1 episode with clinical evidence of HF (without hospitalization) by signs or symptoms of volume overload or elevated intracardiac pressures that required/requires treatment with a diuretic for improvement; OR 1 prior hospitalization for HF. Left ventricular ejection fraction (LVEF) >40%. End-diastolic interventricular septal wall thickness (IVST) ≥12 mm. Willing and able to undergo scintigraphy. Exclusion Criteria: Diagnosis of heart failure with reduced ejection fraction (HFrEF) (EF ≤40%). Prior clinical history of myocardial infarction, CABG or multi-vessel obstructive coronary disease (>50% stenosis of ≥2 epicardial coronary arteries). Presence or history of any severe valvular heart disease (obstructive or regurgitant). A confirmed diagnosis of a non-amyloid infiltrative cardiomyopathy (ie, cardiac sarcoidosis, hemochromatosis), muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy with known genetic etiology, or known pericardial constriction. Any type of diagnosed amyloidosis (eg, amyloid A amyloidosis, primary [light chain] amyloidosis) or prior diagnosis of ATTR-CM. -

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: To determine global prevalence of transthyretin amyloid cardiomyopathy in participants diagnosed with heart failure with preserved ejection fraction. No study treatment will be dispensed however, participants will undergo scintigraphy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ATTR-CM positive<br>Participants diagnosed with ATTR-CM by scintigraphy | Diagnostic Test: Scintigraphy<br>* scintigraphy<br>|
| Other: ATTR-CM negative<br>Participants who are scintigraphy negative for ATTR-CM | Diagnostic Test: Scintigraphy<br>* scintigraphy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate of global prevalence of ATTR-CM in HFpEF patients. | Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1). | Visit 1(baseline) through Follow-Up Visit 1 (Day 44) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate of prevalence of ATTR-CM within region, age and gender | Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1). | Visit 1(baseline) through Follow-Up Visit 1 (Day 44) | 
| Prevalence of patients diagnosed ATTR-CM on study with WT and hereditary forms among patients diagnosed with ATTR CM |  | Visit 1(baseline) through Follow-Up Visit 1 (Day 44) | 
| New York Heart Association (NYHA) Classification of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM |  | Visit 1(baseline) through Follow-Up Visit 1 (Day 44) | 
| Nt-proBNP results of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM |  | Visit 1(baseline) through Follow-Up Visit 1 (Day 44) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevalence, transthyretin amyloid, ATTR-CM, HFpEF, scintigraphy