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Trial record 1 of 1 for:    NCT03842163
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Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology (TTRACK)

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ClinicalTrials.gov Identifier: NCT03842163
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 13, 2019
First Posted Date February 15, 2019
Last Update Posted Date November 20, 2020
Actual Study Start Date July 10, 2018
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 31, 2020)
Number of patients with cardiac fixation at the radionuclide bone scintigraphy and/or SPECT [ Time Frame: Baseline to 6 months ]
• To assess the prevalence of patients with cardiac fixation on a radionuclide bone scintigraphy and/or Single Photon Emission Computed Tomography (SPECT) performed with 99mTc-DPD or 99mTc-PYP or 99mTc-HMDP* among patients with left ventricular hypertrophy (LVH) from an undiagnosed etiology
Original Primary Outcome Measures
 (submitted: February 13, 2019)
Number of patients with cardiac fixation at the radionuclide bone scintigraphy [ Time Frame: Baseline to 6 months ]
To assess the prevalence of patients with cardiac fixation at the radionuclide bone scintigraphy performed with 99mTc-DPD or 99mTc-PYP or 99mTc-HMDP among patients with HCM from undiagnosed etiology
Change History
Current Secondary Outcome Measures
 (submitted: July 31, 2020)
  • Number of patients with mutation at (Transthyretin) TTR coding gene [ Time Frame: Baseline to 6 months ]
    In patients diagnosed with ATTR Amyloidosis to assess the prevalence of hereditary (ATTRv) and wild-type (ATTRwt) ATTR amyloidosis
  • Number of patients with familial history [ Time Frame: Baseline to 6 months ]
    To assess the prevalence of patients with familial history of known cardiomyopathy (CM), polyneuropathy (PN), sudden cardiac death (SCD) among their relatives (ie, parents, siblings and 2nd/3rd degree family members)
  • Number of patients with concomitant signs and symptoms of ATTR amyloidosis [ Time Frame: Baseline to 6 months ]
    • To assess the prevalence in patients with cardiac fixation at the bone scintigraphy/SPECT of concomitant signs or symptoms of ATTR amyloidosis, i.e.:
    • Senso-motor Polyneuropathy
    • Carpal Tunnel syndrome (CTS)
    • Autonomic dysfunction
    • Cardiological manifestations
    • Laboratory signs
    • Others
  • Presence of neurogical signs and/or symptoms compatible with ATTR Polyneuropathy [ Time Frame: Baseline to 6 months ]
    To assess the coexistence of typical neurological signs/symptoms even when overlooked at the first evaluation.
  • Description of specific TTR gene mutation if present [ Time Frame: Baseline to 6 months ]
    To describe the prevalence of TTR genetic mutation** in patients with cardiac fixation at the bone scintigraphy ( visual grade 1 to 3)
  • Comparison of clinical and biochemical characteristics in patients with positive scintigraphy (cardiac fixation at the bone scintigraphy grade 1, 2 or 3) and/or SPECT [ Time Frame: Baseline to 6 months ]
    To compare the clinical and biochemical characteristics between patients with positive scintigraphy (cardiac fixation at the bone scintigraphy grade 1, 2 or 3) and/or SPECT
  • Prevalence of AL or ATTR amyloidosis amyloidosis in patients with cardiac fixation at the bone scintigraphy (visual grade 1 to 3) and/or SPECT [ Time Frame: Baseline to 6 months ]
    To assess the prevalence of AL or ATTR amyloidosis amyloidosis in patients with cardiac fixation at the bone scintigraphy (visual grade 1 to 3) and/or SPECT
Original Secondary Outcome Measures
 (submitted: February 13, 2019)
  • Number of patients with mutation at (Transthyretin) TTR coding gene [ Time Frame: Baseline to 6 months ]
    To assess the prevalence of hereditary (TTRm) or senile (TTRwt) A-TTR
  • Number of patients with familial history [ Time Frame: Baseline to 6 months ]
    To assess the prevalence of patients with familial history of known cardiomyopathy (CM), polyneuropathy (PN), sudden cardiac death (SCD) among their relatives (parents, siblings and 2nd /3rd grade family)
  • Number of patients with concomitant signs and symptoms of ATTR amyloidosis [ Time Frame: Baseline to 6 months ]
    To assess the prevalence of patients with cardiac fixation at the bone scintigraphy of patients with concomitant signs or symptoms of A-TTR, i.e.:
    • Senso-motor Polyneuropathy
    • Carpal Tunnel syndrome (CTS)
    • Autonomic dysfunction
    • Cardiological manifestations
    • Laboratory signs
    • Others
  • Presence of neurological signs and/or symptoms compatible with ATTR Polyneuropathy [ Time Frame: Baseline to 6 months ]
    To assess the coexistence of typical neurological signs/symptoms even when overlooked at the first evaluation.
  • Description of specific TTR gene mutation if present [ Time Frame: Baseline to 6 months ]
    To describe the prevalence of TTR genetic mutation** in patients with cardiac fixation at the bone scintigraphy ( visual grade 1 to 3)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 June 30, 2021
Estimated Primary Completion Date June 30, 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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries Australia,   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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2020