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Status:

TERMINATED

Global Prevalence of ATTR-CM in Participants With HFpEF

Lead Sponsor:

Pfizer

Conditions:

Transthyretin Amyloid Cardiomyopathy

Heart Failure With Preserved Ejection Fraction

Eligibility:

All Genders

60+ years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.
  • \-

Key Trial Info

Start Date :

December 30 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 2 2023

Estimated Enrollment :

347 Patients enrolled

Trial Details

Trial ID

NCT04424914

Start Date

December 30 2020

End Date

June 2 2023

Last Update

July 19 2024

Active Locations (51)

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Page 1 of 13 (51 locations)

1

Eastern shore Research Institute LLC

Fairhope, Alabama, United States, 36532

2

Heart Center Research, LLC

Huntsville, Alabama, United States, 35801

3

Advance Medical Research Center

Miami, Florida, United States, 33135

4

Bioclinical Research Alliance Inc.

Miami, Florida, United States, 33155