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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03842163
Ethics application status
Date submitted
13/02/2019
Date registered
15/02/2019

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

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

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

Patients with LVH of unknown etiology -


Diagnosis / Prognosis: Diagnosis of TTR amyloidosis cardiomyopathy
Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Cardiac Fixation at the Radionuclide Bone Scintigraphy and/or Single Photon Emission Computed Tomography (SPECT): FAS1
Timepoint [1] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [1] 0 0
Percentage of Participants With Transthyretin Amyloid (ATTR): FAS 1
Timepoint [1] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [2] 0 0
Percentage of Participants With ATTR or With Suspicion of Monoclonal Gammopathy of Undetermined Significance (MGUS) / Light Chain Amyloidosis (AL): FAS 1
Timepoint [2] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [3] 0 0
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 2 (FAS 2)
Timepoint [3] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [4] 0 0
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 3 (FAS 3)
Timepoint [4] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [5] 0 0
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.1
Timepoint [5] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [6] 0 0
Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.2
Timepoint [6] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [7] 0 0
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 2
Timepoint [7] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [8] 0 0
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3
Timepoint [8] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [9] 0 0
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.1
Timepoint [9] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [10] 0 0
Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.2
Timepoint [10] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [11] 0 0
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 2
Timepoint [11] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [12] 0 0
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3
Timepoint [12] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [13] 0 0
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.1
Timepoint [13] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [14] 0 0
Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.2
Timepoint [14] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [15] 0 0
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
Timepoint [15] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [17] 0 0
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
Timepoint [17] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [19] 0 0
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
Timepoint [19] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [20] 0 0
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 2
Timepoint [20] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [21] 0 0
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3
Timepoint [21] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [22] 0 0
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.1
Timepoint [22] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [23] 0 0
Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.2
Timepoint [23] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [24] 0 0
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 2
Timepoint [24] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [25] 0 0
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3
Timepoint [25] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [26] 0 0
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.1
Timepoint [26] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [27] 0 0
Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.2
Timepoint [27] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [28] 0 0
Percentage of Participants With Autonomic Dysfunction: FAS 2
Timepoint [28] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [29] 0 0
Percentage of Participants With Autonomic Dysfunction: FAS 3
Timepoint [29] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [30] 0 0
Percentage of Participants With Autonomic Dysfunction: FAS 3.1
Timepoint [30] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [31] 0 0
Percentage of Participants With Autonomic Dysfunction: FAS 3.2
Timepoint [31] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [32] 0 0
Percentage of Participants With Cardiological Manifestations: FAS 2
Timepoint [32] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [33] 0 0
Percentage of Participants With Cardiological Manifestations: FAS 3
Timepoint [33] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [34] 0 0
Percentage of Participants With Cardiological Manifestations: FAS 3.1
Timepoint [34] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [35] 0 0
Percentage of Participants With Cardiological Manifestations: FAS 3.2
Timepoint [35] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [36] 0 0
Percentage of Participants With Laboratory Abnormalities: FAS 2
Timepoint [36] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [37] 0 0
Percentage of Participants With Laboratory Abnormalities: FAS 3
Timepoint [37] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [38] 0 0
Percentage of Participants With Laboratory Abnormalities: FAS 3.1
Timepoint [38] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [39] 0 0
Percentage of Participants With Laboratory Abnormalities: FAS 3.2
Timepoint [39] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [40] 0 0
Number of Participants According to Presence of Neurological Red Flag: FAS1
Timepoint [40] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [41] 0 0
Number of Participants According to Presence of Neurological Red Flag: FAS 2
Timepoint [41] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [42] 0 0
Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1
Timepoint [42] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [43] 0 0
Cardiological Assessments - Blood Pressure: FAS 2
Timepoint [43] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [44] 0 0
Cardiological Assessments - Blood Pressure: FAS 3
Timepoint [44] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [45] 0 0
Cardiological Assessments - Blood Pressure: FAS 3.1
Timepoint [45] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [46] 0 0
Cardiological Assessments - Blood Pressure: FAS 3.2
Timepoint [46] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [47] 0 0
Number of Participants According to History of Clinical Parameters at Baseline: FAS 2
Timepoint [47] 0 0
Baseline
Secondary outcome [48] 0 0
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3
Timepoint [48] 0 0
Baseline
Secondary outcome [49] 0 0
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1
Timepoint [49] 0 0
Baseline
Secondary outcome [50] 0 0
Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2
Timepoint [50] 0 0
Baseline
Secondary outcome [51] 0 0
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2
Timepoint [51] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [52] 0 0
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3
Timepoint [52] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [53] 0 0
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1
Timepoint [53] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [54] 0 0
Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2
Timepoint [54] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [55] 0 0
Number of Participants With Atrial Fibrillation Assessment: FAS 2
Timepoint [55] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [56] 0 0
Number of Participants With Atrial Fibrillation Assessment: FAS 3
Timepoint [56] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [57] 0 0
Number of Participants With Atrial Fibrillation Assessment: FAS 3.1
Timepoint [57] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [58] 0 0
Number of Participants With Atrial Fibrillation Assessment: FAS 3.2
Timepoint [58] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [59] 0 0
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2
Timepoint [59] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [60] 0 0
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3
Timepoint [60] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [61] 0 0
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1
Timepoint [61] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [62] 0 0
Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2
Timepoint [62] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [63] 0 0
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 2
Timepoint [63] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [64] 0 0
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3
Timepoint [64] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [65] 0 0
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.1
Timepoint [65] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [66] 0 0
Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.2
Timepoint [66] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [67] 0 0
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 2
Timepoint [67] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [68] 0 0
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3
Timepoint [68] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [69] 0 0
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.1
Timepoint [69] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [70] 0 0
Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.2
Timepoint [70] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [71] 0 0
Heart Rate Parameter for Participants Without Paced: FAS 2
Timepoint [71] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [72] 0 0
Heart Rate Parameter for Participants Without Paced: FAS 3
Timepoint [72] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [73] 0 0
Heart Rate Parameter for Participants Without Paced: FAS 3.1
Timepoint [73] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [74] 0 0
Heart Rate Parameter for Participants Without Paced: FAS 3.2
Timepoint [74] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [75] 0 0
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2
Timepoint [75] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [76] 0 0
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3
Timepoint [76] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [77] 0 0
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1
Timepoint [77] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [78] 0 0
Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2
Timepoint [78] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [79] 0 0
Sokolow Index: FAS 2
Timepoint [79] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [80] 0 0
Sokolow Index: FAS 3
Timepoint [80] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [81] 0 0
Sokolow Index: FAS 3.1
Timepoint [81] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [82] 0 0
Sokolow Index: FAS 3.2
Timepoint [82] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [83] 0 0
Left Ventricular Ejection Fraction (LVEF): FAS 2
Timepoint [83] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [84] 0 0
Left Ventricular Ejection Fraction (LVEF): FAS 3
Timepoint [84] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [85] 0 0
Left Ventricular Ejection Fraction (LVEF): FAS 3.1
Timepoint [85] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [86] 0 0
Left Ventricular Ejection Fraction (LVEF): FAS 3.2
Timepoint [86] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [87] 0 0
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 2
Timepoint [87] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [88] 0 0
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3
Timepoint [88] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [89] 0 0
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.1
Timepoint [89] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [90] 0 0
Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.2
Timepoint [90] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [91] 0 0
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 2
Timepoint [91] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [92] 0 0
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3
Timepoint [92] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [93] 0 0
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.1
Timepoint [93] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [94] 0 0
Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.2
Timepoint [94] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [95] 0 0
LV End Diastolic Diameter: FAS 2
Timepoint [95] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [96] 0 0
LV End Diastolic Diameter: FAS 3
Timepoint [96] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [97] 0 0
LV End Diastolic Diameter: FAS 3.1
Timepoint [97] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [98] 0 0
LV End Diastolic Diameter: FAS 3.2
Timepoint [98] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [99] 0 0
Maximum Wall Thickness: FAS 2
Timepoint [99] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [100] 0 0
Maximum Wall Thickness: FAS 3
Timepoint [100] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [101] 0 0
Maximum Wall Thickness: FAS 3.1
Timepoint [101] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [102] 0 0
Maximum Wall Thickness: FAS 3.2
Timepoint [102] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [103] 0 0
Number of Participants According to Type of Hypertrophic Pattern: FAS 2
Timepoint [103] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [104] 0 0
Number of Participants According to Type of Hypertrophic Pattern: FAS 3
Timepoint [104] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [105] 0 0
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1
Timepoint [105] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [106] 0 0
Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2
Timepoint [106] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [107] 0 0
LV Mass Index (LVMI): FAS 2
Timepoint [107] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [108] 0 0
LV Mass Index (LVMI): FAS 3
Timepoint [108] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [109] 0 0
LV Mass Index (LVMI): FAS 3.1
Timepoint [109] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [110] 0 0
LV Mass Index (LVMI): FAS 3.2
Timepoint [110] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [111] 0 0
Aortic Valvular Stenosis - Aortic Valve Area: FAS 2
Timepoint [111] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [112] 0 0
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3
Timepoint [112] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [113] 0 0
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.1
Timepoint [113] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcome [114] 0 0
Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.2
Timepoint [114] 0 0
During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)

Eligibility
Key inclusion criteria
Inclusion criteria:

* Patient signed inform consent.
* Males and Females.
* Age =50 years.
* Left ventricular hypertrophy (LVH) defined as end-diastolic LV maximum wall thickness (MWT) =15mm in Echocardiogram.
* Plan to undergo or recently underwent radionuclide bone scintigraphy and/or SPECT with any of the following radio labelled tracers: 99mTc-DPD or 99mTc-PYP or 99mTc-HMDP.
Minimum age
50 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Etiological diagnosis explaining the LVH (p.e. Sarcomeric HCM, Myeloma, Fabry disease, Sarcoidosis, Any type of amyloidosis (AA, AL, TTR)
* Severe aortic stenosis defined as aortic valve area (AVA) < 1.0 cm2

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/06/2022
Sample size
Target
Accrual to date
Final
812
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
The Alfred Department of Cardiology - Melbourne
Recruitment postcode(s) [1] 0 0
4102 - Chermside
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
France
State/province [2] 0 0
Cedex
Country [3] 0 0
France
State/province [3] 0 0
Creteil
Country [4] 0 0
France
State/province [4] 0 0
Nantes cedex 1
Country [5] 0 0
France
State/province [5] 0 0
Toulouse
Country [6] 0 0
Italy
State/province [6] 0 0
Bologna
Country [7] 0 0
Italy
State/province [7] 0 0
Florence
Country [8] 0 0
Portugal
State/province [8] 0 0
Coimbra
Country [9] 0 0
Portugal
State/province [9] 0 0
Lisboa
Country [10] 0 0
Romania
State/province [10] 0 0
Bucharest
Country [11] 0 0
Slovakia
State/province [11] 0 0
Kosice
Country [12] 0 0
Slovenia
State/province [12] 0 0
Ljubljana
Country [13] 0 0
Spain
State/province [13] 0 0
Madrid
Country [14] 0 0
Spain
State/province [14] 0 0
A Coruna
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03842163