Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
NCT03842163
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- 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.
- 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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| 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 | 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:
Exclusion criteria:
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| Sex/Gender |
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| Ages | 50 Years to 99 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | July 2020 | ||||