Global Prevalence of ATTR-CM in Participants With HFpEF

Pfizer

Status: Terminated

Conditions: Transthyretin Amyloid Cardiomyopathy; Heart Failure With Preserved Ejection Fraction

Treatments: Diagnostic Test: Scintigraphy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04424914

B3461087

ATTR-POP (Other Identifier)

2020-002378-29 (EudraCT Number)

HFpEF ATTR-CM prevalence study (Other Identifier)

Details and patient eligibility

About

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)].

Enrollment: 347 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Medical history of heart failure (HF) with:

   1. 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
   2. 1 prior hospitalization for HF.

2. Left ventricular ejection fraction (LVEF) >40%.

3. End-diastolic interventricular septal wall thickness (IVST) ≥12 mm.

4. Willing and able to undergo scintigraphy.

Exclusion criteria

1. Diagnosis of heart failure with reduced ejection fraction (HFrEF) (EF ≤40%).

2. Prior clinical history of myocardial infarction, CABG or multi-vessel obstructive coronary disease (>50% stenosis of ≥2 epicardial coronary arteries).

3. Presence or history of any severe valvular heart disease (obstructive or regurgitant).

4. 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.

5. Any type of diagnosed amyloidosis (eg, amyloid A amyloidosis, primary [light chain] amyloidosis) or prior diagnosis of ATTR-CM.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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347 participants in 2 patient groups

ATTR-CM positive

Other group

Description:

Participants diagnosed with ATTR-CM by scintigraphy

Treatment:

Diagnostic Test: Scintigraphy

ATTR-CM negative

Other group

Description:

Participants who are scintigraphy negative for ATTR-CM

Treatment:

Diagnostic Test: Scintigraphy