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Global Prevalence of ATTR-CM in Participants With HFpEF

Primary Purpose

Transthyretin Amyloid Cardiomyopathy, Heart Failure With Preserved Ejection Fraction

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Scintigraphy
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Transthyretin Amyloid Cardiomyopathy focused on measuring prevalence, transthyretin amyloid, ATTR-CM, HFpEF, scintigraphy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

    -

Sites / Locations

  • Eastern shore Research Institute LLC
  • Heart Center Research, LLC
  • Advance Medical Research Center
  • Bioclinical Research Alliance Inc.
  • Biogenix Molecular
  • CIRA (Nuclear Imaging Facility)
  • Nucleotron/ Doral Imaging Institute, CIRA DBA
  • Innova Pharma Research
  • Ocala Cardiovascular Research
  • Chicago Medical Research, LLC
  • Advocate Christ Medical Center
  • Stormont Vail Health
  • Cotton O'Neil Heart Center
  • Ochsner Medical Center
  • Corewell Health
  • Spectrum Health Medical Group Cardiovascular Medicine
  • Cardiology Associates of North Mississippi, LLC
  • Cardiology Associates Research, LLC
  • NYU Langone Health
  • WakeMed Health and Hospital
  • The Jackson Clinic
  • Providence Sacred Heart Medical Center and Children's Hospital
  • University of Ottawa Heart Institute
  • CardioVasc HR Inc
  • Diex Recherche Trois-Rivieres
  • Hôpital Louis Pradel
  • Centre Hospitalier Saint-Joseph Saint-Luc
  • CHU Nimes - Hospital Caremeau
  • CHU de Toulouse - Hôpital de Rangueil
  • Médecine Nucléaire de la Doua
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
  • U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS
  • U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS
  • Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche
  • Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare
  • Nagoya Tokushukai General Hospital
  • Fukuoka Tokushukai Hospital
  • Keio University Hospital
  • Okayama University Hospital
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
  • Krakowski Szpital Specjalistyczny im. Jana Pawła II
  • Uniwersytecki Szpital Kliniczny w Białymstoku
  • SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Universitari Vall d´Hebron
  • Hospital Clinic de Barcelona
  • Hospital Universitari De Bellvitge
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
  • Hospital Universitari i Politècnic La Fe
  • St George's Hospital, St George's University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

ATTR-CM positive

ATTR-CM negative

Arm Description

Participants diagnosed with ATTR-CM by scintigraphy

Participants who are scintigraphy negative for ATTR-CM

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Prevalence of patients diagnosed ATTR-CM on study with WT and hereditary forms among patients diagnosed with ATTR CM
New York Heart Association (NYHA) Classification of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM
Nt-proBNP results of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM

Full Information

First Posted
May 27, 2020
Last Updated
July 11, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04424914
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor terminated study early to not prolong timelines and to enable sharing of data collected which has potential to better support understanding of the prevalence of ATTR-CM in patients with HFpEF. Decision was not based on any safety findings.
Study Start Date
December 30, 2020 (Actual)
Primary Completion Date
June 2, 2023 (Actual)
Study Completion Date
June 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transthyretin Amyloid Cardiomyopathy, Heart Failure With Preserved Ejection Fraction
Keywords
prevalence, transthyretin amyloid, ATTR-CM, HFpEF, scintigraphy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
319 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATTR-CM positive
Arm Type
Other
Arm Description
Participants diagnosed with ATTR-CM by scintigraphy
Arm Title
ATTR-CM negative
Arm Type
Other
Arm Description
Participants who are scintigraphy negative for ATTR-CM
Intervention Type
Diagnostic Test
Intervention Name(s)
Scintigraphy
Intervention Description
scintigraphy
Primary Outcome Measure Information:
Title
Estimate of global prevalence of ATTR-CM in HFpEF patients.
Description
Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1).
Time Frame
Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
Secondary Outcome Measure Information:
Title
Estimate of prevalence of ATTR-CM within region, age and gender
Description
Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1).
Time Frame
Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
Title
Prevalence of patients diagnosed ATTR-CM on study with WT and hereditary forms among patients diagnosed with ATTR CM
Time Frame
Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
Title
New York Heart Association (NYHA) Classification of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM
Time Frame
Visit 1(baseline) through Follow-Up Visit 1 (Day 44)
Title
Nt-proBNP results of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM
Time Frame
Visit 1(baseline) through Follow-Up Visit 1 (Day 44)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Eastern shore Research Institute LLC
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
Heart Center Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Advance Medical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Bioclinical Research Alliance Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Biogenix Molecular
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
CIRA (Nuclear Imaging Facility)
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Nucleotron/ Doral Imaging Institute, CIRA DBA
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Innova Pharma Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Ocala Cardiovascular Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Chicago Medical Research, LLC
City
Hazel Crest
State/Province
Illinois
ZIP/Postal Code
60429
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Stormont Vail Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
Cotton O'Neil Heart Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Corewell Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health Medical Group Cardiovascular Medicine
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Cardiology Associates of North Mississippi, LLC
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Cardiology Associates Research, LLC
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
WakeMed Health and Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
The Jackson Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Providence Sacred Heart Medical Center and Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
CardioVasc HR Inc
City
Saint-Jean-sur-Richelieu
State/Province
Quebec
ZIP/Postal Code
J3A 1C3
Country
Canada
Facility Name
Diex Recherche Trois-Rivieres
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G9A 4P3
Country
Canada
Facility Name
Hôpital Louis Pradel
City
Bron Cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Centre Hospitalier Saint-Joseph Saint-Luc
City
LYON cedex 07
ZIP/Postal Code
69365
Country
France
Facility Name
CHU Nimes - Hospital Caremeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
CHU de Toulouse - Hôpital de Rangueil
City
Toulouse cedex 9
ZIP/Postal Code
50032 - 31059
Country
France
Facility Name
Médecine Nucléaire de la Doua
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS
City
Genova
State/Province
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Nagoya Tokushukai General Hospital
City
Kasugai
State/Province
Aichi
ZIP/Postal Code
487-0016
Country
Japan
Facility Name
Fukuoka Tokushukai Hospital
City
Kasuga
State/Province
Fukuoka
ZIP/Postal Code
816-0864
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawła II
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny w Białymstoku
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-276
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Łodzi Centralny Szpital
City
Łódź
State/Province
Łódzkie
ZIP/Postal Code
90-549
Country
Poland
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitari Vall d´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitari De Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
St George's Hospital, St George's University Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B3461087
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Global Prevalence of ATTR-CM in Participants With HFpEF

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