Global Prevalence of ATTR-CM in Participants With HFpEF

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04424914

Collaborator

(none)

2,000

Enrollment

Locations

Arms

42.5

Anticipated Duration (Months)

62.5

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

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)].

Condition or Disease	Intervention/Treatment	Phase
Transthyretin Amyloid Cardiomyopathy Heart Failure With Preserved Ejection Fraction	Diagnostic Test: Scintigraphy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

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.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)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Dec 30, 2020

Anticipated Primary Completion Date :

Jul 15, 2024

Anticipated Study Completion Date :

Jul 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: ATTR-CM positive Participants diagnosed with ATTR-CM by scintigraphy	Diagnostic Test: Scintigraphy scintigraphy
Other: ATTR-CM negative Participants who are scintigraphy negative for ATTR-CM	Diagnostic Test: Scintigraphy scintigraphy

Arm

Intervention/Treatment

Other: ATTR-CM positive

Participants diagnosed with ATTR-CM by scintigraphy

Diagnostic Test: Scintigraphy

scintigraphy

Other: ATTR-CM negative

Participants who are scintigraphy negative for ATTR-CM

Diagnostic Test: Scintigraphy

scintigraphy

Outcome Measures

Primary Outcome Measures

Estimate of global prevalence of ATTR-CM in HFpEF patients. [Visit 1(baseline) through Follow-Up Visit 1 (Day 44)]
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 [Visit 1(baseline) through Follow-Up Visit 1 (Day 44)]
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 [Visit 1(baseline) through Follow-Up Visit 1 (Day 44)]
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)]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	Ocala Cardiovascular Research	Ocala	Florida	United States	34471
5	Chicago Medical Research, LLC	Hazel Crest	Illinois	United States	60429
6	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453
7	Stormont Vail Health	Topeka	Kansas	United States	66604
8	Cotton O'Neil Heart Center	Topeka	Kansas	United States	66606
9	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
10	Cardiology Associates of North Mississippi, LLC	Tupelo	Mississippi	United States	38801
11	Cardiology Associates Research, LLC	Tupelo	Mississippi	United States	38801
12	NYU Langone Health	New York	New York	United States	10016
13	WakeMed Health and Hospital	Raleigh	North Carolina	United States	27610
14	Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington	United States	99204
15	Hôpital Louis Pradel	Bron Cedex		France	69677
16	Centre Hospitalier Saint-Joseph Saint-Luc	LYON cedex 07		France	69365
17	CHU de Toulouse - Hôpital de Rangueil	Toulouse cedex 9		France	50032 - 31059
18	Médecine Nucléaire de la Doua	Villeurbanne		France	69100
19	U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS	Genova	Genoa	Italy	16132
20	U.O. Clinica delle Malattie dell'Apparato Cardiovascolare - Ospedale Policlinico San Martino IRCCS	Genova		Italy	16132
21	Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche	Pavia		Italy	27100
22	Fondazione Toscana Gabriele Monasterio-UOC Cardiologia e Medicina Cardiovascolare	Pisa		Italy	56124
23	Nagoya Tokushukai General Hospital	Kasugai	Aichi	Japan	487-0016
24	Fukuoka Tokushukai Hospital	Kasuga	Fukuoka	Japan	816-0864
25	Keio University Hospital	Shinjuku-ku	Tokyo	Japan	160-8582
26	Okayama University Hospital	Okayama		Japan	700-8558
27	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid	Spain	28222
28	Hospital Universitari Vall d´Hebron	Barcelona		Spain	08035
29	Hospital Clinic de Barcelona	Barcelona		Spain	08036
30	Hospital Universitari De Bellvitge	Barcelona		Spain	08907
31	Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca	Salamanca		Spain	37007
32	St George's Hospital, St George's University Hospitals NHS Foundation Trust	London		United Kingdom	SW17 0QT