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Clinical Trials/NCT03842163
NCT03842163CompletedNot Applicable

PREVALENCE AND CHARACTERISTICS OF TRANSTHYRETIN AMYLOIDOSIS IN PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY OF UNKNOWN ETIOLOGY TTRACK

Pfizer18 sites in 10 countries812 target enrollmentStarted: July 9, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Pfizer
Enrollment
812
Locations
18
Primary Endpoint
Percentage of Participants With Cardiac Fixation at the Radionuclide Bone Scintigraphy and/or Single Photon Emission Computed Tomography (SPECT): FAS1
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
50 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Percentage of Participants With Autonomic Dysfunction: FAS 3.2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Percentage of Participants With Cardiological Manifestations: FAS 2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Percentage of Participants With Cardiological Manifestations: FAS 3(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(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(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(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(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(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(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(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(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(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Cardiological Assessments - Blood Pressure: FAS 3.1(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 3.1(Baseline)
  • Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Cardiological Assessments - Blood Pressure: FAS 2(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 3.2(Baseline)
  • Cardiological Assessments - Blood Pressure: FAS 3(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Cardiological Assessments - Blood Pressure: FAS 3.2(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(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(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(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(Baseline)
  • Number of Participants According to History of Clinical Parameters at Baseline: FAS 3(Baseline)
  • Number of Participants Classified According to New York Heart Association (NYHA) Class: FAS 3.1(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(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(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(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(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(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(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(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(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(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Heart Rate Parameter for Participants Without Paced: FAS 2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Number of Participants With Magnetic Resonance Imaging (MRI) Scan Performed Using Late Gadolinium Enhancement (LGE): FAS 3.1(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(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(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(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(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(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Heart Rate Parameter for Participants Without Paced: FAS 3(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Sokolow Index: FAS 3(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Heart Rate Parameter for Participants Without Paced: FAS 3.1(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Heart Rate Parameter for Participants Without Paced: FAS 3.2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.1(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Number of Participants Assessed for Sinus Rhythm Parameter for Participants Without Paced: FAS 3.2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Sokolow Index: FAS 2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Sokolow Index: FAS 3.2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Left Ventricular Ejection Fraction (LVEF): FAS 2(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(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(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Sokolow Index: FAS 3.1(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(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Left Ventricular Ejection Fraction (LVEF): FAS 3(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(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(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(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • LV End Diastolic Diameter: FAS 2(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(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(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(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(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • LV End Diastolic Diameter: FAS 3.1(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • LV End Diastolic Diameter: FAS 3(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Maximum Wall Thickness: FAS 2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • LV End Diastolic Diameter: FAS 3.2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Maximum Wall Thickness: FAS 3.1(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Number of Participants According to Type of Hypertrophic Pattern: FAS 2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Maximum Wall Thickness: FAS 3.2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Number of Participants According to Type of Hypertrophic Pattern: FAS 3(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Maximum Wall Thickness: FAS 3(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • LV Mass Index (LVMI): FAS 2(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Number of Participants According to Type of Hypertrophic Pattern: FAS 3.1(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(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • LV Mass Index (LVMI): FAS 3(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • LV Mass Index (LVMI): FAS 3.1(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • LV Mass Index (LVMI): FAS 3.2(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(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(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(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(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(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))
  • Percentage of Participants With Transthyretin Amyloid (ATTR): FAS 1(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)(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(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)(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(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(During collection and observation duration from 09-Jul-2018 to 08-Jun-2022 (approximately 3.11 years))

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (18)

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