Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
TTRACK
PREVALENCE AND CHARACTERISTICS OF TRANSTHYRETIN AMYLOIDOSIS IN PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY OF UNKNOWN ETIOLOGY TTRACK
2 other identifiers
observational
812
8 countries
15
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2018
CompletedFirst Submitted
Initial submission to the registry
February 13, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2022
CompletedResults Posted
Study results publicly available
February 12, 2024
CompletedFebruary 12, 2024
May 1, 2023
3.9 years
February 13, 2019
May 31, 2023
May 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Cardiac Fixation at the Radionuclide Bone Scintigraphy and/or Single Photon Emission Computed Tomography (SPECT): FAS1
Percentage of participants with cardiac fixation on a radionuclide bone scintigraphy and/or SPECT performed with 99mTc-DPD or 99mTc-PYP or 999mTc-HMDP among participants with LVH from an undiagnosed etiology were reported in this outcome measure. Scintigraphy was defined at each bone site according to the standard grading: Grade 0 = absent cardiac uptake, Grade 1=mild uptake less than bone, Grade 2=moderate uptake equal to bone and Grade 3=high uptake greater than bone.
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary Outcomes (114)
Percentage of Participants With Transthyretin Amyloid (ATTR): FAS 1
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With ATTR or With Suspicion of Monoclonal Gammopathy of Undetermined Significance (MGUS) / Light Chain Amyloidosis (AL): FAS 1
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 2 (FAS 2)
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 3 (FAS 3)
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.1
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
- +109 more secondary outcomes
Study Arms (1)
Patients with LVH of unknown etiology
Interventions
Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy
Eligibility Criteria
Patients with HCM from undiagnosed etiology
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (18)
The Prince Charles Hospital
Chermside, 4102, Australia
The Alfred Department of Cardiology
Melbourne, Australia
Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III, Kardiologie
Innsbruck, A-6020, Austria
Centre Hospitalier Universitaire de Caen
Caen, Cedex, 14033, France
Hopital Henri Mondor, Service de Pharmacologie Clinique
Créteil, 94000, France
CHU de Nantes
Nantes, 44093, France
CHU de Toulouse
Toulouse, 31100, France
Divisione di Cardiologia
Bologna, 40128, Italy
Careggi Hospital
Florence, 50134, Italy
Centro Hospitalar e Universitario de Coimbra
Coimbra, 3000-075, Portugal
Centro Hospitalar de Lisboa Central, E.P.E.
Lisbon, 1150-199, Portugal
Fundeni Clinical Institute
Bucharest, 022328, Romania
Inherited Cardiovascular Diseases - Cardiology Institute
Bucharest, 030171, Romania
East Slovak Institute of Cardiovascular Diseases
Košice, 4011, Slovakia
University Medical Centre Ljubljana - Department of Cardiology
Ljubljana, 1000, Slovenia
Cardiomyopathy Unit, Department of Cardiology
Majadahonda, Madrid, 28222, Spain
Hospital Universitario A Coruna
A Coruña, 15006, Spain
The Heart Hospital - University College London Hospitals Nhs Foundation Trust
London, W1G 8PH, United Kingdom
Related Publications (1)
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 Dec;12(6):4349-4358. doi: 10.1002/ehf2.15440. Epub 2025 Oct 13.
PMID: 41081448DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2019
First Posted
February 15, 2019
Study Start
July 9, 2018
Primary Completion
June 8, 2022
Study Completion
June 8, 2022
Last Updated
February 12, 2024
Results First Posted
February 12, 2024
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share
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.