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

NCT03842163

Last updated date
Study Location
Centre Hospitalier Universitaire de Caen
Caen, Cedex, 14033, France
Contact
1-800-718-1021

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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

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


- 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

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Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
NCT03842163
  1. Caen, Cedex
  2. Nantes cedex 1,
  3. Bologna,
  4. Bucharest,
  5. Bucharest,
  6. Ljubljana,
  7. Innsbruck,
  8. Florence,
  9. A Coruna,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title 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
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with HCM from undiagnosed etiology
Condition Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Intervention Diagnostic Test: Diagnosis of TTR amyloidosis cardiomyopathy
Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy
Study Groups/Cohorts Patients 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 Status Recruiting
Estimated Enrollment
 (submitted: February 13, 2019)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study:All
Ages 50 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Austria,   France,   Italy,   Romania,   Slovenia,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03842163
Other Study ID Numbers B3461058
TTRACK ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020