Clinical trial NCT03842163: Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
Official title: PREVALENCE AND CHARACTERISTICS OF TRANSTHYRETIN AMYLOIDOSIS IN PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY OF UNKNOWN ETIOLOGY TTRACK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Keywords: Scintigraphy
Gammagraphy
TTR
ATTR
Hypertrophic cardiomyopathy (HCM)
HCM
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 812
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HCM from undiagnosed etiology

Brief summary: The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) \>15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol


Eligibility 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.

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

Primary outcomes:
measure: Percentage of Participants With Cardiac Fixation at the Radionuclide Bone Scintigraphy and/or Single Photon Emission Computed Tomography (SPECT): FAS1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Secondary outcomes:
measure: Percentage of Participants With Transthyretin Amyloid (ATTR): FAS 1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With ATTR or With Suspicion of Monoclonal Gammopathy of Undetermined Significance (MGUS) / Light Chain Amyloidosis (AL): FAS 1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 2 (FAS 2)
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): Full Analysis Set 3 (FAS 3)
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Hereditary Transthyretin Amyloid (ATTRv): FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Wild Type Transthyretin Amyloid (ATTRwt): FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Transthyretin (TTR) Genetic Mutations Among Those Who Had Positive Scintigraphy: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: 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
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: 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
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: 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
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: 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
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: 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
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Senso-Motor Polyneuropathy: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Senso-Motor Polyneuropathy: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Carpal Tunnel Syndrome (CTS): FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Autonomic Dysfunction: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Autonomic Dysfunction: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Autonomic Dysfunction: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Autonomic Dysfunction: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Cardiological Manifestations: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Cardiological Manifestations: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Cardiological Manifestations: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Cardiological Manifestations: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Laboratory Abnormalities: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Laboratory Abnormalities: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Laboratory Abnormalities: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Percentage of Participants With Laboratory Abnormalities: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants According to Presence of Neurological Red Flag: FAS1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants According to Presence of Neurological Red Flag: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants According to Discrepancies Between Scintigraphy Result and Single Photon Emission Computed Tomography (SPECT) Result: FAS1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Cardiological Assessments - Blood Pressure: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Cardiological Assessments - Blood Pressure: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Cardiological Assessments - Blood Pressure: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Cardiological Assessments - Blood Pressure: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants According to History of Clinical Parameters at Baseline: FAS 2
timeFrame: Baseline
measure: Number of Participants According to History of Clinical Parameters at Baseline: FAS 3
timeFrame: Baseline
measure: Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.1
timeFrame: Baseline
measure: Number of Participants According to History of Clinical Parameters at Baseline: FAS 3.2
timeFrame: Baseline
measure: Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Atrial Fibrillation Assessment: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Atrial Fibrillation Assessment: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Atrial Fibrillation Assessment: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Atrial Fibrillation Assessment: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Pacemaker and Implantable Cardiac Defibrillator (ICD): FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants According to Assessment for Electrocardiogram (ECG) Paced: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Heart Rate Parameter for Participants Without Paced: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Heart Rate Parameter for Participants Without Paced: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Heart Rate Parameter for Participants Without Paced: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Heart Rate Parameter for Participants Without Paced: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Sokolow Index: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Sokolow Index: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Sokolow Index: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Sokolow Index: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Left Ventricular Ejection Fraction (LVEF): FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Left Ventricular Ejection Fraction (LVEF): FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Left Ventricular Ejection Fraction (LVEF): FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Left Ventricular Ejection Fraction (LVEF): FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Assessed for Left Ventricular Outflow Tract Obstruction (LVOT): FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Categorized According to Perseverance of Strain Apical: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants Categorized According to Perseverance of Strain Apical: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: LV End Diastolic Diameter: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: LV End Diastolic Diameter: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: LV End Diastolic Diameter: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: LV End Diastolic Diameter: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Maximum Wall Thickness: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Maximum Wall Thickness: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Maximum Wall Thickness: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Maximum Wall Thickness: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants According to Type of Hypertrophic Pattern: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants According to Type of Hypertrophic Pattern: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Number of Participants According to Type of Hypertrophic Pattern: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: LV Mass Index (LVMI): FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: LV Mass Index (LVMI): FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: LV Mass Index (LVMI): FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: LV Mass Index (LVMI): FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Aortic Valvular Stenosis - Aortic Valve Area: FAS 2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Aortic Valvular Stenosis - Aortic Valve Area: FAS 3
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.1
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
measure: Aortic Valvular Stenosis - Aortic Valve Area: FAS 3.2
timeFrame: During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years)
Other outcomes:
Locations:
city: Chermside
country: Australia
facility: The Prince Charles Hospital
city: Melbourne
country: Australia
facility: The Alfred Department of Cardiology
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III, Kardiologie
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen
state: Cedex
city: Creteil
country: France
facility: Hopital Henri Mondor, Service de Pharmacologie Clinique
city: Nantes cedex 1
country: France
facility: CHU de Nantes
city: Toulouse
country: France
facility: CHU de Toulouse
city: Bologna
country: Italy
facility: Divisione di Cardiologia
city: Florence
country: Italy
facility: Careggi Hospital
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Central, E.P.E.
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Bucharest
country: Romania
facility: Inherited Cardiovascular Diseases - Cardiology Institute
city: Kosice
country: Slovakia
facility: East Slovak Institute of Cardiovascular Diseases
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana - Department of Cardiology
city: Majadahonda
country: Spain
facility: Cardiomyopathy Unit, Department of Cardiology
state: Madrid
city: A Coruna
country: Spain
facility: Hospital Universitario A Coruna
city: London
country: United Kingdom
facility: The Heart Hospital - University College London Hospitals Nhs Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: