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

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03842163

Collaborator

(none)

1,500

Enrollment

Locations

53.7

Anticipated Duration (Months)

83.3

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)	Diagnostic Test: Diagnosis of TTR amyloidosis cardiomyopathy

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

PREVALENCE AND CHARACTERISTICS OF TRANSTHYRETIN AMYLOIDOSIS IN PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY OF UNKNOWN ETIOLOGY TTRACK

Actual Study Start Date :

Jul 9, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with LVH of unknown etiology	Diagnostic Test: Diagnosis of TTR amyloidosis cardiomyopathy Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy

Arm

Intervention/Treatment

Patients with LVH of unknown etiology

Diagnostic Test: Diagnosis of TTR amyloidosis cardiomyopathy

Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy

Outcome Measures

Primary Outcome Measures

Number of patients with cardiac fixation at the radionuclide bone scintigraphy and/or SPECT [Baseline to 6 months]
• 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

Secondary Outcome Measures

Number of patients with mutation at (Transthyretin) TTR coding gene [Baseline to 6 months]
In patients diagnosed with ATTR Amyloidosis to assess the prevalence of hereditary (ATTRv) and wild-type (ATTRwt) ATTR amyloidosis
Number of patients with familial history [Baseline to 6 months]
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)
Number of patients with concomitant signs and symptoms of ATTR amyloidosis [Baseline to 6 months]
• 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
Presence of neurogical signs and/or symptoms compatible with ATTR Polyneuropathy [Baseline to 6 months]
To assess the coexistence of typical neurological signs/symptoms even when overlooked at the first evaluation.
Description of specific TTR gene mutation if present [Baseline to 6 months]
To describe the prevalence of TTR genetic mutation** in patients with cardiac fixation at the bone scintigraphy ( visual grade 1 to 3)
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 [Baseline to 6 months]
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
Prevalence of AL or ATTR amyloidosis amyloidosis in patients with cardiac fixation at the bone scintigraphy (visual grade 1 to 3) and/or SPECT [Baseline to 6 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Heart and Lung Transplant Unit	Darlinghurst	New South Wales	Australia	2010
2	The Prince Charles Hospital	Chermside		Australia	4102
3	The Alfred Department of Cardiology	Melbourne		Australia
4	Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III, Kardiologie	Innsbruck		Austria	A-6020
5	Centre Hospitalier Universitaire de Caen	Caen	Cedex	France	14033
6	Hopital Antoine Beclere	Clamart		France	92141
7	Hopital Henri Mondor, Service de Pharmacologie Clinique	Creteil		France	94000
8	CHU de Nantes	Nantes cedex 1		France	44093
9	CHU de Toulouse	Toulouse		France	31100
10	Divisione di Cardiologia	Bologna		Italy	40128
11	Careggi Hospital	Florence		Italy	50134
12	Fundeni Clinical Institute	Bucharest		Romania	022328
13	Inherited Cardiovascular Diseases - Cardiology Institute	Bucharest		Romania	030171
14	East Slovak Institute of Cardiovascular Diseases	Kosice		Slovakia	4011
15	University Medical Centre Ljubljana - Department of Cardiology	Ljubljana		Slovenia	1000
16	Cardiomyopathy Unit, Department of Cardiology	Majadahonda	Madrid	Spain	28222
17	Hospital Universitario A Coruna	A Coruna		Spain	15006
18	The Heart Hospital - University College London Hospitals Nhs Foundation Trust	London		United Kingdom	W1G 8PH