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

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

Study Overview

• Status: Completed
• Conditions: Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
• Intervention / Treatment: Diagnostic test: Diagnosis of TTR amyloidosis cardiomyopathy

• Study Type: Observational
• Enrollment (Actual): 812

Contacts and Locations

Study Locations

• Australia
  • Chermside, Australia, 4102
    • The Prince Charles Hospital
  • Melbourne, Australia
    • The Alfred Department of Cardiology
• Austria
  • Innsbruck, Austria, A-6020
    • Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III, Kardiologie
• France
  • Creteil, France, 94000
    • Hopital Henri Mondor, Service de Pharmacologie Clinique
  • Nantes cedex 1, France, 44093
    • CHU de Nantes
  • Toulouse, France, 31100
    • CHU de Toulouse
  • Cedex
    • Caen, Cedex, France, 14033
      • Centre Hospitalier Universitaire de Caen
• Italy
  • Bologna, Italy, 40128
    • Divisione di Cardiologia
  • Florence, Italy, 50134
    • Careggi Hospital
• Portugal
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar E Universitário De Coimbra
  • Lisboa, Portugal, 1150-199
    • Centro Hospitalar de Lisboa Central, E.P.E.
• Romania
  • Bucharest, Romania, 022328
    • Fundeni Clinical Institute
  • Bucharest, Romania, 030171
    • Inherited Cardiovascular Diseases - Cardiology Institute
• Slovakia
  • Kosice, Slovakia, 4011
    • East Slovak Institute of Cardiovascular Diseases
• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana - Department of Cardiology
• Spain
  • A Coruna, Spain, 15006
    • Hospital Universitario A Coruña
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Cardiomyopathy Unit, Department of Cardiology
• United Kingdom
  • London, United Kingdom, W1G 8PH
    • The Heart Hospital - University College London Hospitals Nhs Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with HCM from undiagnosed etiology

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with LVH of unknown etiology	Diagnostic test: Diagnosis of TTR amyloidosis cardiomyopathy; Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Transthyretin Amyloid (ATTR): FAS 1	Transthyretin amyloidosis is a slowly progressive condition characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues.	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	Transthyretin amyloidosis is a slowly progressive condition characterized by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues.	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)	Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.	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)	Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.	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	Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.	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 3.2	Percentage of participants with hereditary ATTRv were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with variant transthyretin was considered as ATTRv.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 2	Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3	Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.1	Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.2	Percentage of participants with ATTRwt were reported in this outcome measure. ATTR participants with a ATTR gene sequencing with a result of 'no mutation' was considered as ATTRwt.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 2	Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3	Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.1	Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants with TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.2	Scintigraphy is the procedure used to diagnose, stage, and monitor disease. A small amount of a radioactive chemical (radionuclide) was injected into a vein or swallowed. Number of participants With TTR genetic mutations among those who had positive scintigraphy were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 1	Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a left ventricular (LV) wall thickness greater than or equal to (>=) 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 2	Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness >= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3	Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness >= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.1	Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness >= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Any Familial History of Known Cardiomyopathy (CM), Polyneuropathy (PN) or Sudden Cardiac Death (SCD) Among Their Relatives (Parents, Siblings and 2nd /3rd Grade Family): FAS 3.2	Percentage of participants with any of the familial history of known CM, PN or SCD among their relatives were reported in this outcome measure. Family history for each disease was considered for 1st degree parent, siblings, and 2nd/3rd grade family. CM was defined by the presence of a LV wall thickness >= 15 mm in one or more LV myocardial segments that is not explained solely by abnormal loading conditions. Polyneuropathy was defined as the simultaneous malfunction of many peripheral nerves throughout the body. SCD was defined as death due to a cardiovascular cause that occurs within one hour of the onset of symptoms. A sudden cardiac arrest occurs when the heart stops beating or is not beating sufficiently to maintain perfusion and life.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 2	Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags Electronic Case Report Form (e-CRF) part was considered as participants with a senso-motor polyneuropathy.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3	Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.1	Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.2	Participants with at least one red flag in the neurological part of the ATTR-Amyloidosis red flags e-CRF part was considered as participants with a senso-motor polyneuropathy.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 2	CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3	CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.1	CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.2	CTS was defined as a common neurological disorder that occurs when the median nerve, which runs from your forearm into the palm of the hand, becomes pressed or squeezed at the wrist. Participants with a CTS were participants with a bilateral or unilateral CTS.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Autonomic Dysfunction: FAS 2	Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Autonomic Dysfunction: FAS 3	Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Autonomic Dysfunction: FAS 3.1	Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Autonomic Dysfunction: FAS 3.2	Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Cardiological Manifestations: FAS 2	Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval less than (<) 80 milliseconds (ms) or greater than (>) 350 ms QRS interval < 60 ms or > 250 ms, Sokolow index < 1 mm or > 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter <20 mm or >80 mm, MWT <15 mm or >100 mm, MWT at septum <3 mm or >50 mm, MWT posterior wall <3 mm or >50 mm, LV mass index <40 g/m^2 or >160 g/m^2, Maximal aortic velocity >5 m/s, Mean gradient of Aortic valvular stenosis >70 mmHg, Area of Aortic valvular stenosis <0.2 cm^2 or >3 cm^2.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Cardiological Manifestations: FAS 3	Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval < 80 ms or > 350 ms QRS interval < 60 ms or > 250 ms, Sokolow index < 1 mm or > 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter <20 mm or >80 mm, MWT <15 mm or >100 mm, MWT at septum <3 mm or >50 mm, MWT posterior wall <3 mm or >50 mm, LV mass index <40 g/m^2 or >160 g/m^2, Maximal aortic velocity >5 m/s, Mean gradient of Aortic valvular stenosis >70 mmHg, Area of Aortic valvular stenosis <0.2 cm^2 or >3 cm^2.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Cardiological Manifestations: FAS 3.1	Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval < 80 ms or > 350 ms QRS interval < 60 ms or > 250 ms, Sokolow index < 1 mm or > 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter <20 mm or >80 mm, MWT <15 mm or >100 mm, MWT at septum <3 mm or >50 mm, MWT posterior wall <3 mm or >50 mm, LV mass index <40 g/m^2 or >160 g/m^2, Maximal aortic velocity >5 m/s, Mean gradient of Aortic valvular stenosis >70 mmHg, Area of Aortic valvular stenosis <0.2 cm^2 or >3 cm^2.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Cardiological Manifestations: FAS 3.2	Participants with cardiological manifestations was defined as participants with at least one of the following criteria fulfilled from data collected from e-CRF: cardiological assessments: atrial fibrillation (yes permanent), pacemaker (yes), AICD (yes); in magnetic resonance imaging (MRI) part: LGE (positive); electrocardiogram (ECG) part: PR interval < 80 ms or > 350 ms QRS interval < 60 ms or > 250 ms, Sokolow index < 1 mm or > 70 mm, pseudo MI pattern (yes), PPOr precordial R wave progression(yes), LBBB, RBBB, paced and intraventricular conduct delay (ticked), LVOT (yes), if longitudinal strain is done, strain apical preserved (yes), LV end-diastolic diameter <20 mm or >80 mm, MWT <15 mm or >100 mm, MWT at septum <3 mm or >50 mm, MWT posterior wall <3 mm or >50 mm, LV mass index <40 g/m^2 or >160 g/m^2, Maximal aortic velocity >5 m/s, Mean gradient of Aortic valvular stenosis >70 mmHg, Area of Aortic valvular stenosis <0.2 cm^2 or >3 cm^2.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Laboratory Abnormalities: FAS 2	Laboratory parameters that were considered as out of range included creatinine <45 micromole per liter (μmol/L) or greater than 104 μmol/L w; haemoglobin, participants with a value lower than 11.5 grams per deciliter (g/dL) or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 picograms per milliliter (pg/mL); N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Laboratory Abnormalities: FAS 3	Laboratory parameters that were considered as out of range included creatinine <45 μmol/L or greater than 104 μmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Laboratory Abnormalities: FAS 3.1	Laboratory parameters that were considered as out of range included creatinine <45 μmol/L or greater than 104 μmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Percentage of Participants With Laboratory Abnormalities: FAS 3.2	Laboratory parameters that were considered as out of range included creatinine <45 μmol/L or greater than 104 μmol/L w; haemoglobin value lower than 11.5 g/dL or higher than 16 g/dL was considered as out of range; Brain natriuretic peptide (BNP) value higher than 100 pg/mL; N-terminal pro-brain natriuretic peptide (NTproBNP), value higher than 125 pg/mL; Troponin I value higher than 26 pg/mL.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants According to Presence of Neurological Red Flag: FAS1	Participants were classified according to presence of neurological red flag as 'Yes' or 'No'.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants According to Presence of Neurological Red Flag: FAS 2	Participants were classified according to presence of neurological red flag as 'Yes' or 'No'.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1	Grade of scintigraphy evaluated by the investigator and Grade of SPECT: 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. Only categories with non-zero values were reported.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Cardiological Assessments - Blood Pressure: FAS 2	Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Cardiological Assessments - Blood Pressure: FAS 3	SBP and DBP were evaluated.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Cardiological Assessments - Blood Pressure: FAS 3.1	SBP and DBP were evaluated.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Cardiological Assessments - Blood Pressure: FAS 3.2	SBP and DBP were evaluated.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2	Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.	Baseline
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3	Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.	Baseline
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1	Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.	Baseline
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2	Clinical parameters' assessment for hypertension, antihypertensive medication, coronary artery disease, renal insufficiency, diabetes mellitus, lumbar spinal stenosis, carpal tunnel syndrome was categorized as 'Yes' and 'No', where Yes indicated presence and No indicated absence.	Baseline
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2	Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3	Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1	Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2	Participants classified according to NYHA class as Class I, Class II, Class III, Class IV were reported in this outcome measure. Class I: no symptoms and no limitation in ordinary physical activity, such as shortness of breath when walking, climbing stairs. Class II: mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: marked limitation in activity due to symptoms, even during less-than-ordinary activity, such as walking short distances (20-100 meters), comfortable only at rest. Class IV: severe limitations and experienced symptoms even while at rest, mostly bedbound participants.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Atrial Fibrillation Assessment: FAS 2	Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Atrial Fibrillation Assessment: FAS 3	Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Atrial Fibrillation Assessment: FAS 3.1	Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Atrial Fibrillation Assessment: FAS 3.2	Participants were classified according to presence of atrial fibrillation as 'No', 'Yes permanent', 'Yes in the past' and were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2	Participants who used pacemaker and ICD were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3	Participants who used pacemaker and ICD were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1	Participants who used pacemaker and ICD were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2	Participants who used pacemaker and ICD were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 2	Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3	Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.1	Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.2	Participants with MRI scan performed using LGE classified as 'negative' and 'positive' were reported in this outcome measure. LGE was defined as method where cardiovascular magnetic resonance (CMR) images were obtained after the administration of gadolinium contrast material that accumulated into a tissue with increased extra cellular space.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 2	Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3	Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.1	Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.2	Participants classified according to assessment for ECG for paced participants as 'Yes' or 'No' were reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Heart Rate Parameter for Participants Without Paced: FAS 2		During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Heart Rate Parameter for Participants Without Paced: FAS 3		During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Heart Rate Parameter for Participants Without Paced: FAS 3.1		During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Heart Rate Parameter for Participants Without Paced: FAS 3.2		During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2		During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3		During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1		During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2		During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Sokolow Index: FAS 2	Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Sokolow Index: FAS 3	Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Sokolow Index: FAS 3.1	Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Sokolow Index: FAS 3.2	Sokolow index is calculated as sum of the amplitude of the S wave in in right precordial lead V1 and the amplitude of the highest R wave in left precordial leads V5 or V6. If the result is greater than 35 mm, it is suggestive of left ventricular hypertrophy.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Left Ventricular Ejection Fraction (LVEF): FAS 2	LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Left Ventricular Ejection Fraction (LVEF): FAS 3	LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Left Ventricular Ejection Fraction (LVEF): FAS 3.1	LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Left Ventricular Ejection Fraction (LVEF): FAS 3.2	LVEF was defined as the central measure of left ventricular systolic function. LVEF was the fraction of stroke volume (volume ejected in systole) in relation to the volume of the blood in the ventricle at the end of diastole volume (EDV). LVEF was presented in percentage.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 2	LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3	LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.1	LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.2	LVOT is defined as limitation of blood flow out of the left ventricle. The level of obstruction can be valvular, sub-valvular, or supravalvular. In this outcome measure participants were categorized as Yes or No on the basis of presence or absence of LVOT.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 2	Participants were classified according to strain apical preserved as 'No' and 'Yes'.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3	Participants were classified according to strain apical preserved as 'No' and 'Yes'.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.1	Participants were classified according to strain apical preserved as 'No' and 'Yes'.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.2	Participants were classified according to strain apical preserved as 'No' and 'Yes'.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
LV End Diastolic Diameter: FAS 2	Left ventricular end-diastolic diameter (LVEDD) reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
LV End Diastolic Diameter: FAS 3	LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
LV End Diastolic Diameter: FAS 3.1	LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
LV End Diastolic Diameter: FAS 3.2	LVEDD reflects the size of cardiac as well as left ventricular function. It was associated with progressive left ventricular insufficiency.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Maximum Wall Thickness: FAS 2		During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Maximum Wall Thickness: FAS 3		During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Maximum Wall Thickness: FAS 3.1		During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Maximum Wall Thickness: FAS 3.2		During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants According to Type of Hypertrophic Pattern: FAS 2	Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants According to Type of Hypertrophic Pattern: FAS 3	Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1	Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2	Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
LV Mass Index (LVMI): FAS 2	Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
LV Mass Index (LVMI): FAS 3	Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
LV Mass Index (LVMI): FAS 3.1	Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
LV Mass Index (LVMI): FAS 3.2	Left ventricular mass (LVM) is the weight of the left ventricle, typically estimated using echocardiography, and is thought to represent the cumulative effect of blood pressure on the heart. Closely related to body size, greater in men than in women, and increases with age. LVMI = LVM (left ventricular mass)/body surface area.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Aortic Valvular Stenosis - Aortic Valve Area: FAS 2	Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3	Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.1	Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.2	Aortic valve stenosis is a type of heart valve disease (valvular heart disease). The valve between the lower left heart chamber and the body's main artery (aorta) is narrowed and doesn't open fully. This reduces or blocks blood flow from the heart to the aorta and to the rest of the body. Parameters needed to classify the aortic valve stenosis: peak transvalvular velocity, mean pressure gradient and aortic valve area. Here, aortic valve area is reported in this outcome measure.	During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): June 8, 2022
• Study Completion (Actual): June 8, 2022

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: TTR; ATTR; HCM; Scintigraphy; Gammagraphy; Hypertrophic cardiomyopathy (HCM)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Proteostasis Deficiencies; Metabolism, Inborn Errors; Heredodegenerative Disorders, Nervous System; Cardiomegaly; Amyloidosis, Familial; Amyloid Neuropathies; Amyloidosis; Hypertrophy; Cardiomyopathies; Amyloid Neuropathies, Familial; Hypertrophy, Left Ventricular
• Other Study ID Numbers: B3461058; TTRACK (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No