Global Prevalence of ATTR-CM in Participants With HFpEF

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04424914
• Other study ID #: B3461087
• Secondary ID: HFpEF ATTR-CM pr
• Status: Terminated
• Phase: N/A
• Start date: December 30, 2020
• Est. completion date: June 2, 2023

Study information

• Verified date: July 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)].

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 319
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

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Related Conditions & MeSH terms

• Amyloidosis
• Cardiomyopathies
• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Transthyretin Amyloid Cardiomyopathy

Intervention

Diagnostic Test:
• Scintigraphy
scintigraphy

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	CardioVasc HR Inc	Saint-Jean-sur-Richelieu	Quebec
Canada	Diex Recherche Trois-Rivieres	Trois-Rivieres	Quebec
France	Hôpital Louis Pradel	Bron Cedex
France	Centre Hospitalier Saint-Joseph Saint-Luc	LYON cedex 07
France	CHU Nimes - Hospital Caremeau	Nimes
France	CHU de Toulouse - Hôpital de Rangueil	Toulouse cedex 9
France	Médecine Nucléaire de la Doua	Villeurbanne
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola	Bologna	BO
Italy	U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS	Genova	Genoa
Italy	U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS	Genova
Italy	Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche	Pavia
Italy	Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare	Pisa
Japan	Fukuoka Tokushukai Hospital	Kasuga	Fukuoka
Japan	Nagoya Tokushukai General Hospital	Kasugai	Aichi
Japan	Okayama University Hospital	Okayama
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok	Podlaskie
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II	Krakow	Malopolskie
Poland	SPZOZ Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej UM W Lodzi Centralny Szpital	Lódz	Lódzkie
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw	Dolnoslaskie
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw	Dolnoslaskie
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitari De Bellvitge	Barcelona
Spain	Hospital Universitari Vall d´Hebron	Barcelona
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca	Salamanca
Spain	Hospital Universitari i Politècnic La Fe	Valencia
United Kingdom	St George's Hospital, St George's University Hospitals NHS Foundation Trust	London
United States	Eastern shore Research Institute LLC	Fairhope	Alabama
United States	Corewell Health	Grand Rapids	Michigan
United States	Spectrum Health Medical Group Cardiovascular Medicine	Grand Rapids	Michigan
United States	Chicago Medical Research, LLC	Hazel Crest	Illinois
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	The Jackson Clinic	Jackson	Tennessee
United States	Advance Medical Research Center	Miami	Florida
United States	Bioclinical Research Alliance Inc.	Miami	Florida
United States	Biogenix Molecular	Miami	Florida
United States	CIRA (Nuclear Imaging Facility)	Miami	Florida
United States	Innova Pharma Research	Miami	Florida
United States	Nucleotron/ Doral Imaging Institute, CIRA DBA	Miami	Florida
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	NYU Langone Health	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Ocala Cardiovascular Research	Ocala	Florida
United States	WakeMed Health and Hospital	Raleigh	North Carolina
United States	Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington
United States	Cotton O'Neil Heart Center	Topeka	Kansas
United States	Stormont Vail Health	Topeka	Kansas
United States	Cardiology Associates of North Mississippi, LLC	Tupelo	Mississippi
United States	Cardiology Associates Research, LLC	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy,  Japan,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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