Clinical trial NCT04424914: Global Prevalence of ATTR-CM in Participants With HFpEF
Official title: GLOBAL PREVALENCE OF TRANSTHYRETIN AMYLOID CARDIOMYOPATHY (ATTR-CM) IN PARTICIPANTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFpEF)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Transthyretin Amyloid Cardiomyopathy
Heart Failure With Preserved Ejection Fraction
Keywords: prevalence
transthyretin amyloid
ATTR-CM
HFpEF
scintigraphy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 347
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SCREENING

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 \[participants with heart failure with preserved ejection fraction (HFpEF)\].


Eligibility criteria: 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.

   -

Primary outcomes:
measure: Global Prevalence of ATTR-CM in HFpEF Participants Clinically At-Risk of Disease Among Total Evaluable Participants
timeFrame: Day 1
Secondary outcomes:
measure: Global Prevalence of ATTR-CM in Participants With HFpEF Clinically At-Risk of Disease by Subgroups (Regions, Age, Gender) Among Total Evaluable Participants
timeFrame: Day 1
measure: Number of Participants According to TTR Genotypes Among Participants Diagnosed With ATTR-CM
timeFrame: Day 1
measure: Number of HFpEF Participants With and Without ATTR-CM Based on New York Heart Association (NYHA) Classification
timeFrame: Day 1
measure: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) in Participants With and Without ATTR-CM
timeFrame: Day 1
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Eastern shore Research Institute LLC
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Miami
country: United States
facility: Advance Medical Research Center
state: Florida
city: Miami
country: United States
facility: Bioclinical Research Alliance Inc.
state: Florida
city: Miami
country: United States
facility: Biogenix Molecular
state: Florida
city: Miami
country: United States
facility: CIRA (Nuclear Imaging Facility)
state: Florida
city: Miami
country: United States
facility: Nucleotron/ Doral Imaging Institute, CIRA DBA
state: Florida
city: Miami
country: United States
facility: Innova Pharma Research
state: Florida
city: Ocala
country: United States
facility: Ocala Cardiovascular Research
state: Florida
city: Hazel Crest
country: United States
facility: Chicago Medical Research, LLC
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Topeka
country: United States
facility: Stormont Vail Health
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Heart Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group Cardiovascular Medicine
state: Michigan
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi, LLC
state: Mississippi
city: Tupelo
country: United States
facility: Cardiology Associates Research, LLC
state: Mississippi
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Raleigh
country: United States
facility: WakeMed Health and Hospital
state: North Carolina
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center and Children's Hospital
state: Washington
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Saint-Jean-sur-Richelieu
country: Canada
facility: CardioVasc HR Inc
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Diex Recherche Trois-Rivieres
state: Quebec
city: Bron Cedex
country: France
facility: Hôpital Louis Pradel
city: LYON cedex 07
country: France
facility: Centre Hospitalier Saint-Joseph Saint-Luc
city: Nimes
country: France
facility: CHU Nimes - Hospital Caremeau
city: Toulouse cedex 9
country: France
facility: CHU de Toulouse - Hôpital de Rangueil
city: Villeurbanne
country: France
facility: Médecine Nucléaire de la Doua
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
state: BO
city: Genova
country: Italy
facility: U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS
state: Genoa
city: Genova
country: Italy
facility: U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche
city: Pisa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare
city: Kasugai
country: Japan
facility: Nagoya Tokushukai General Hospital
state: Aichi
city: Kasuga
country: Japan
facility: Fukuoka Tokushukai Hospital
state: Fukuoka
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
state: Dolnoslaskie
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
state: Dolnośląskie
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II
state: Malopolskie
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Białymstoku
state: Podlaskie
city: Łódź
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital
state: Łódzkie
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d´Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari De Bellvitge
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: London
country: United Kingdom
facility: St George's Hospital, St George's University Hospitals NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: