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AzTrials

Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)TTRACKNCT03842163

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

An observational study of Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM), run by Pfizer at 18 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 50 to 99 years
What is being tested?
Diagnosis of TTR amyloidosis cardiomyopathy
How many people
812 participants
Where
18 sitesin 10 countries
Study dates
9 Jul 2018to 8 Jun 2022
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with HCM from undiagnosed etiology

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

18 sites in 10 countries.

18 sites in 10 countries

France4 sites
  • Centre Hospitalier Universitaire de Caen

    Caen, Cedex, 14033

  • Hopital Henri Mondor, Service de Pharmacologie Clinique

    Créteil, 94000

  • CHU de Nantes

    Nantes, 44093

  • CHU de Toulouse

    Toulouse, 31100

Other trials in France

Australia2 sites
  • The Prince Charles Hospital

    Chermside, 4102

  • The Alfred Department of Cardiology

    Melbourne

Other trials in Australia

Italy2 sites
  • Divisione di Cardiologia

    Bologna, 40128

  • Careggi Hospital

    Florence, 50134

Other trials in Italy

Portugal2 sites
  • Centro Hospitalar e Universitario de Coimbra

    Coimbra, 3000-075

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

    Lisbon, 1150-199

Other trials in Portugal

Romania2 sites
  • Fundeni Clinical Institute

    Bucharest, 022328

  • Inherited Cardiovascular Diseases - Cardiology Institute

    Bucharest, 030171

Other trials in Romania

Spain2 sites
  • Hospital Universitario A Coruna

    A Coruña, 15006

  • Cardiomyopathy Unit, Department of Cardiology

    Majadahonda, Madrid, 28222

Other trials in Spain

Austria1 site
  • Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III, Kardiologie

    Innsbruck, A-6020

Other trials in Austria

Slovakia1 site
  • East Slovak Institute of Cardiovascular Diseases

    Košice, 4011

Other trials in Slovakia

Slovenia1 site
  • University Medical Centre Ljubljana - Department of Cardiology

    Ljubljana, 1000

Other trials in Slovenia

United Kingdom1 site
  • The Heart Hospital - University College London Hospitals Nhs Foundation Trust

    London, W1G 8PH

Other trials in United Kingdom

About this study

Official title: 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

Being tested
Diagnosis of TTR amyloidosis cardiomyopathy
Keywords
Scintigraphy, Gammagraphy, TTR, ATTR, Hypertrophic cardiomyopathy (HCM), HCM
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnosis of TTR amyloidosis cardiomyopathyDiagnostic test

    Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy

Study groups in NCT03842163
Study groupRoleWhat they receive
Patients with LVH of unknown etiologyNot described
Receives: Diagnostic Test: Diagnosis of TTR amyloidosis cardiomyopathy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Secondary outcomes (114)
  1. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  2. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  3. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  4. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  5. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  6. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  7. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  8. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  9. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  10. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  11. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  12. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  13. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  14. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  15. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  16. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  17. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  18. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  19. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  20. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  21. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  22. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  23. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  24. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  25. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  26. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  27. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  28. Percentage of Participants With Autonomic Dysfunction: FAS 2

    Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  29. Percentage of Participants With Autonomic Dysfunction: FAS 3

    Participants with autonomic dysfunction were participants with at least one autonomic sign or autonomic symptom = "Yes".

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  30. 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".

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  31. 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".

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  32. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  33. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  34. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  35. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  36. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  37. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  38. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  39. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  40. 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'.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  41. 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'.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  42. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  43. Cardiological Assessments - Blood Pressure: FAS 2

    Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  44. Cardiological Assessments - Blood Pressure: FAS 3

    SBP and DBP were evaluated.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  45. Cardiological Assessments - Blood Pressure: FAS 3.1

    SBP and DBP were evaluated.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  46. Cardiological Assessments - Blood Pressure: FAS 3.2

    SBP and DBP were evaluated.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  47. 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.

    Measured: Baseline

  48. 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.

    Measured: Baseline

  49. 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.

    Measured: Baseline

  50. 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.

    Measured: Baseline

  51. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  52. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  53. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  54. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  55. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  56. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  57. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  58. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  59. Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2

    Participants who used pacemaker and ICD were reported in this outcome measure.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  60. Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3

    Participants who used pacemaker and ICD were reported in this outcome measure.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  61. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  62. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  63. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  64. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  65. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  66. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  67. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  68. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  69. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  70. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  71. Heart Rate Parameter for Participants Without Paced: FAS 2

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  72. Heart Rate Parameter for Participants Without Paced: FAS 3

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  73. Heart Rate Parameter for Participants Without Paced: FAS 3.1

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  74. Heart Rate Parameter for Participants Without Paced: FAS 3.2

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  75. Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  76. Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  77. Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  78. Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  79. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  80. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  81. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  82. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  83. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  84. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  85. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  86. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  87. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  88. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  89. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  90. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  91. Number of Participants Categorized According to Perseverance of Strain Apical: FAS 2

    Participants were classified according to strain apical preserved as 'No' and 'Yes'.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  92. Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3

    Participants were classified according to strain apical preserved as 'No' and 'Yes'.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  93. 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'.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  94. 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'.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  95. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  96. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  97. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  98. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  99. Maximum Wall Thickness: FAS 2

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  100. Maximum Wall Thickness: FAS 3

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  101. Maximum Wall Thickness: FAS 3.1

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  102. Maximum Wall Thickness: FAS 3.2

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  103. Number of Participants According to Type of Hypertrophic Pattern: FAS 2

    Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  104. Number of Participants According to Type of Hypertrophic Pattern: FAS 3

    Participants were classified according to hypertrophic pattern as apical, concentric, asymmetric and mix.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  105. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  106. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  107. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  108. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  109. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  110. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  111. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  112. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  113. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

  114. 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.

    Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start9 Jul 2018
  3. Primary completion8 Jun 2022
  4. Study completion8 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
812 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03842163
Sponsor's protocol ID
B3461058
Other IDs
TTRACK
Acronym
TTRACK
Status last verified
May 2023
First submitted
13 Feb 2019
Last updated
12 Feb 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 41081448

Questions about this trial

What is this clinical trial studying?

An observational study of Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM), run by Pfizer at 18 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France, Australia, Italy, Portugal, Romania and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Cardiac Fixation at the Radionuclide Bone Scintigraphy and/or Single Photon Emission Computed Tomography (SPECT): FAS1 (time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03842163, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.

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