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

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NCT03842163

Last updated on October 17, 2019
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Study Location
Hospital Universitario A Coruna
A Coruna, , 15006 Spain
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-99 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age ≥ 50 years

- Left ventricular hypertrophy (LVH): (Defined by end-diastolic LV maximum wall
thickness (MWT) ≥15mm in ECHO)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Etiological diagnosis explaining the LVH:

o Sarcomeric HCM, Myeloma, Fabry disease, Sarcoidosis, Any type of amyloidosis (AA,
AL, TTR*...)

- Severe aortic stenosis (Aortic valve area (AVA)

NCT03842163
Pfizer
Recruiting
Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology

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Descriptive Information
Brief TitlePrevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
Official TitlePREVALENCE AND CHARACTERISTICS OF TRANSTHYRETIN AMYLOIDOSIS IN PATIENTS WITH LEFT VENTRICULAR HYPERTROPHY OF UNKNOWN ETIOLOGY TTRACK
Brief SummaryThe 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
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients with HCM from undiagnosed etiology
ConditionTransthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
InterventionDiagnostic Test: Diagnosis of TTR amyloidosis cardiomyopathy
Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy
Study Groups/CohortsPatients with LVH of unknown etiology
Intervention: Diagnostic Test: Diagnosis of TTR amyloidosis cardiomyopathy
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusRecruiting
Estimated Enrollment
 (submitted: February 13, 2019)		1500
Original Estimated EnrollmentSame as current
Estimated Study Completion DateDecember 31, 2019
Estimated Primary Completion DateDecember 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

  • Age ? 50 years
  • Left ventricular hypertrophy (LVH): (Defined by end-diastolic LV maximum wall thickness (MWT) ?15mm in ECHO)

Exclusion criteria:

  • Etiological diagnosis explaining the LVH:

    o Sarcomeric HCM, Myeloma, Fabry disease, Sarcoidosis, Any type of amyloidosis (AA, AL, TTR*...)

  • Severe aortic stenosis (Aortic valve area (AVA) < 1.0 cm2)
Sex/Gender
Sexes Eligible for Study:All
Ages50 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesSpain
Removed Location Countries  
 
Administrative Information
NCT NumberNCT03842163
Other Study ID NumbersB3461058
TTRACK ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description: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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2019

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