Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology

NCT ID: NCT03842163

Last Updated: 2024-02-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

812 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-09

Study Completion Date

2022-06-08

Brief Summary

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The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) \>15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol

Detailed Description

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Conditions

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Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with LVH of unknown etiology

Diagnosis of TTR amyloidosis cardiomyopathy

Intervention Type DIAGNOSTIC_TEST

Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy

Interventions

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Diagnosis of TTR amyloidosis cardiomyopathy

Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patient signed inform consent.
* Males and Females.
* Age ≥50 years.
* Left ventricular hypertrophy (LVH) defined as end-diastolic LV maximum wall thickness (MWT) ≥15mm in Echocardiogram.
* Plan to undergo or recently underwent radionuclide bone scintigraphy and/or SPECT with any of the following radio labelled tracers: 99mTc-DPD or 99mTc-PYP or 99mTc-HMDP.

Exclusion Criteria

* Etiological diagnosis explaining the LVH (p.e. Sarcomeric HCM, Myeloma, Fabry disease, Sarcoidosis, Any type of amyloidosis (AA, AL, TTR)
* Severe aortic stenosis defined as aortic valve area (AVA) \< 1.0 cm2
Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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The Prince Charles Hospital

Chermside, , Australia

Site Status

The Alfred Department of Cardiology

Melbourne, , Australia

Site Status

Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III, Kardiologie

Innsbruck, , Austria

Site Status

Centre Hospitalier Universitaire de Caen

Caen, Cedex, France

Site Status

Hopital Henri Mondor, Service de Pharmacologie Clinique

Créteil, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

CHU de Toulouse

Toulouse, , France

Site Status

Divisione di Cardiologia

Bologna, , Italy

Site Status

Careggi Hospital

Florence, , Italy

Site Status

Centro Hospitalar e Universitario de Coimbra

Coimbra, , Portugal

Site Status

Centro Hospitalar de Lisboa Central, E.P.E.

Lisbon, , Portugal

Site Status

Fundeni Clinical Institute

Bucharest, , Romania

Site Status

Inherited Cardiovascular Diseases - Cardiology Institute

Bucharest, , Romania

Site Status

East Slovak Institute of Cardiovascular Diseases

Košice, , Slovakia

Site Status

University Medical Centre Ljubljana - Department of Cardiology

Ljubljana, , Slovenia

Site Status

Cardiomyopathy Unit, Department of Cardiology

Majadahonda, Madrid, Spain

Site Status

Hospital Universitario A Coruna

A Coruña, , Spain

Site Status

The Heart Hospital - University College London Hospitals Nhs Foundation Trust

London, , United Kingdom

Site Status

Countries

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Australia Austria France Italy Portugal Romania Slovakia Slovenia Spain United Kingdom

References

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Garcia-Pavia P, Del Moral FJH, Cappelli F, Piriou N, Barriales-Villa R, Munteanu C, Bahus C, Keohane D, Mallaina P, Itti E, Damy T, Elliott P. Nuclear imaging and echocardiographic findings in hypertrophic cardiomyopathy with and without ATTR-CM. ESC Heart Fail. 2025 Oct 13. doi: 10.1002/ehf2.15440. Online ahead of print.

Reference Type DERIVED
PMID: 41081448 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B3461058

To obtain contact information for a study center near you, click here.

Other Identifiers

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TTRACK

Identifier Type: OTHER

Identifier Source: secondary_id

B3461058

Identifier Type: -

Identifier Source: org_study_id

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