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.
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
- Conditions the study is for
- Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
- 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
Australia2 sites
The Prince Charles Hospital
Chermside, 4102
The Alfred Department of Cardiology
Melbourne
Italy2 sites
Divisione di Cardiologia
Bologna, 40128
Careggi Hospital
Florence, 50134
Portugal2 sites
Centro Hospitalar e Universitario de Coimbra
Coimbra, 3000-075
Centro Hospitalar de Lisboa Central, E.P.E.
Lisbon, 1150-199
Romania2 sites
Fundeni Clinical Institute
Bucharest, 022328
Inherited Cardiovascular Diseases - Cardiology Institute
Bucharest, 030171
Spain2 sites
Hospital Universitario A Coruna
A Coruña, 15006
Cardiomyopathy Unit, Department of Cardiology
Majadahonda, Madrid, 28222
Austria1 site
Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III, Kardiologie
Innsbruck, A-6020
Slovenia1 site
University Medical Centre Ljubljana - Department of Cardiology
Ljubljana, 1000
United Kingdom1 site
The Heart Hospital - University College London Hospitals Nhs Foundation Trust
London, W1G 8PH
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 group | Role | What they receive |
|---|---|---|
| Patients with LVH of unknown etiology | Not 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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Maximum Wall Thickness: FAS 2
Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Maximum Wall Thickness: FAS 3
Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Maximum Wall Thickness: FAS 3.1
Measured: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Maximum Wall Thickness: FAS 3.2
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
- First posted15 Feb 2019
- Study start9 Jul 2018
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVALENCE AND CHARACTERISTICS OF TRANSTHYRETIN AMYLOIDOSIS IN PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY OF UNKNOWN ETIOLOGY TTRACK
- ClinicalTrials.gov ID
- NCT03842163
- Acronym / sponsor ID
- TTRACK / B3461058
- Keywords
- Scintigraphy, Gammagraphy, TTR, ATTR, Hypertrophic cardiomyopathy (HCM), HCM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Posted 12 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with LVH of unknown etiology | – | Diagnostic Test: Diagnosis of TTR amyloidosis cardiomyopathy |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HCM from undiagnosed etiology
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of TTR amyloidosis cardiomyopathyDiagnosis of TTR amyloidosis cardiomyopathy with scintigraphy | Diagnostic test | Patients with LVH of unknown etiology |
Primary outcome
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)
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.
114 secondary outcomes
Percentage of Participants With Transthyretin Amyloid (ATTR): FAS 1
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41081448Garcia-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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
18 sites in 10 countries: see every site and its status.
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.