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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03842163




Registration number
NCT03842163
Ethics application status
Date submitted
13/02/2019
Date registered
15/02/2019
Date last updated
8/03/2021

Titles & IDs
Public title
Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
Scientific title
PREVALENCE AND CHARACTERISTICS OF TRANSTHYRETIN AMYLOIDOSIS IN PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY OF UNKNOWN ETIOLOGY TTRACK
Secondary ID [1] 0 0
TTRACK
Secondary ID [2] 0 0
B3461058
Universal Trial Number (UTN)
Trial acronym
TTRACK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM) 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Neurological 0 0 0 0
Other neurological disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Diagnosis of TTR amyloidosis cardiomyopathy

Patients with LVH of unknown etiology -


Diagnosis / Prognosis: Diagnosis of TTR amyloidosis cardiomyopathy
Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy

Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with cardiac fixation at the radionuclide bone scintigraphy and/or SPECT - • To assess the prevalence of patients with cardiac fixation on a radionuclide bone scintigraphy and/or Single Photon Emission Computed Tomography (SPECT) performed with 99mTc-DPD or 99mTc-PYP or 99mTc-HMDP* among patients with left ventricular hypertrophy (LVH) from an undiagnosed etiology
Timepoint [1] 0 0
Baseline to 6 months
Secondary outcome [1] 0 0
Number of patients with mutation at (Transthyretin) TTR coding gene - In patients diagnosed with ATTR Amyloidosis to assess the prevalence of hereditary (ATTRv) and wild-type (ATTRwt) ATTR amyloidosis
Timepoint [1] 0 0
Baseline to 6 months
Secondary outcome [2] 0 0
Number of patients with familial history - To assess the prevalence of patients with familial history of known cardiomyopathy (CM), polyneuropathy (PN), sudden cardiac death (SCD) among their relatives (ie, parents, siblings and 2nd/3rd degree family members)
Timepoint [2] 0 0
Baseline to 6 months
Secondary outcome [3] 0 0
Number of patients with concomitant signs and symptoms of ATTR amyloidosis - • To assess the prevalence in patients with cardiac fixation at the bone scintigraphy/SPECT of concomitant signs or symptoms of ATTR amyloidosis, i.e.:
Senso-motor Polyneuropathy
Carpal Tunnel syndrome (CTS)
Autonomic dysfunction
Cardiological manifestations
Laboratory signs
Others
Timepoint [3] 0 0
Baseline to 6 months
Secondary outcome [4] 0 0
Presence of neurogical signs and/or symptoms compatible with ATTR Polyneuropathy - To assess the coexistence of typical neurological signs/symptoms even when overlooked at the first evaluation.
Timepoint [4] 0 0
Baseline to 6 months
Secondary outcome [5] 0 0
Description of specific TTR gene mutation if present - To describe the prevalence of TTR genetic mutation** in patients with cardiac fixation at the bone scintigraphy ( visual grade 1 to 3)
Timepoint [5] 0 0
Baseline to 6 months
Secondary outcome [6] 0 0
Comparison of clinical and biochemical characteristics in patients with positive scintigraphy (cardiac fixation at the bone scintigraphy grade 1, 2 or 3) and/or SPECT - To compare the clinical and biochemical characteristics between patients with positive scintigraphy (cardiac fixation at the bone scintigraphy grade 1, 2 or 3) and/or SPECT
Timepoint [6] 0 0
Baseline to 6 months
Secondary outcome [7] 0 0
Prevalence of AL or ATTR amyloidosis amyloidosis in patients with cardiac fixation at the bone scintigraphy (visual grade 1 to 3) and/or SPECT - To assess the prevalence of AL or ATTR amyloidosis amyloidosis in patients with cardiac fixation at the bone scintigraphy (visual grade 1 to 3) and/or SPECT
Timepoint [7] 0 0
Baseline to 6 months

Eligibility
Key inclusion criteria
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.
Minimum age
50 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 0 0
4102 - Chermside
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
France
State/province [2] 0 0
Cedex
Country [3] 0 0
France
State/province [3] 0 0
Clamart
Country [4] 0 0
France
State/province [4] 0 0
Creteil
Country [5] 0 0
France
State/province [5] 0 0
Nantes cedex 1
Country [6] 0 0
France
State/province [6] 0 0
Toulouse
Country [7] 0 0
Italy
State/province [7] 0 0
Bologna
Country [8] 0 0
Italy
State/province [8] 0 0
Florence
Country [9] 0 0
Romania
State/province [9] 0 0
Bucharest
Country [10] 0 0
Slovenia
State/province [10] 0 0
Ljubljana
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
Spain
State/province [12] 0 0
A Coruna

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT03842163
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03842163