Understanding ATTR Amyloidosis: A Real-World Study
This study, called OverTTuRe, is looking at how people with ATTR amyloidosis (a condition where abnormal proteins build up in organs) experience their disease. Researchers want to understand characteristics of patients, how their condition is treated, and how it affects their health and daily life. This is an observational study, meaning researchers will look at existing medical information and will not be giving any new treatments. They are interested in things like how often people visit doctors or emergency rooms. You could be eligible if you are over 18 and have a diagnosis of amyloidosis, have received ATTR-specific treatment, or have a positive biopsy for ATTR. The study aims to gather information from over 52,000 people to get a broad picture of the disease.
- Study design
- This is a retrospective, observational study looking at existing medical records from many countries. It aims to include over 52,000 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants' health care resource utilization will be assessed from diagnosis up to a maximum of 12 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
OverTTuRe: Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis
At a glance
Conditions
Where it's being run
29 sites across 11 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Health Care Resource Utilization (HCRU) - Outpatient visitsFrom diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years
Annualized events rate for: Overall outpatient visits
- Health Care Resource Utilization (HCRU) - Outpatient visits by specialtyFrom diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years
Annualized events rate for: Overall outpatient visits by specialty
- Health Care Resource Utilization (HCRU) - Emergency department visitsFrom diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years
Annualized events rate for: Emergency department visits
- Health Care Resource Utilization (HCRU) - Hospitalizations, length of stayFrom diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years
Annualized events rate for: Hospitalizations (bed days)
- Health Care Resource Utilization (HCRU) - HospitalizationsFrom diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years
Annualized events rate for: Hospitalizations Overlaps (e.g., hospitalization after emergency department visit) are allowed and counted as separate visits
- Health Care Resource Utilization (HCRU) - Health care costFrom diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years
This variable will describe all-cause direct medical and pharmacy costs only, utilizing the amount charged, where available in the data. The direct medical costs will include costs incurred from inpatient stays, outpatient visits, emergency room visits, procedures, and laboratory tests. The inclusion of pharmacy costs is subject to data availability and will include all pharmacy costs per patient separated on pharmacy dispensed and in-hospital dispensed when possible. When feasible, costs will be divided on all-cause, CV, and other specialties
- Cardiac transplantFrom diagnosis of ATTR amyloidosis (index date) until date of first cardiac transplant, assessed throughout the study until end of follow-up, up to a maximum of 12 years
Cardiac transplant (Time to event)
- All cause mortalityFrom diagnosis of ATTR amyloidosis (index date) until date of death due to any cause, assessed throughout the study until end of follow-up, up to a maximum of 12 years
Mortality (time-to-event)
- Liver transplantFrom diagnosis of ATTR amyloidosis (index date) until date of first liver transplant, assessed throughout the study until end of follow-up, up to a maximum of 12 years
Liver transplant (time-to-event)
- Heart Failure HospitalizationFrom diagnosis of ATTR amyloidosis (index date) until date of first hospitalization for heart failure, assessed throughout the study until end of follow-up, up to a maximum of 12 years
Heart failure hospitalization (time-to-event)
- New ATTR amyloidosis clinical manifestationFrom diagnosis of ATTR amyloidosis (index date) until date of first diagnosis of new ATTR amyloidosis clinical manifestation, assessed throughout the study until end of follow-up, up to a maximum of 12 years
New amyloidosis manifestation (time-to-event); Time to the first development of a new clinical manifestation that the patient did not have pre-index)
- Hospitalization (any cause)From diagnosis of ATTR amyloidosis (index date) until date of first hospitalization for any reason, assessed throughout the study until end of follow-up, up to a maximum of 12 years
Time to hospitalization (all-cause)
- Neuropathy Impairment Score (NIS)From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years
The NIS Score has a range of 0 to 244 and a higher NIS score indicates poorer function
- Neuropathy Impairment Score Lower Limbs (NIS-LL)From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years
The NIS-LL score has a range of 0-88 and a greater NIS-LL score indicates poorer function
- Neuropathy Impairment Score +7 (NIS+7)From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years
The NIS+7 Score has a range of -26.04 to 270.04 and a higher NIS+7 score indicates poorer function
- Neuropathy Impairment Score modified +7 (mNIS+7)From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years
The mNIS+7 Score has a range of -22.32 to 102.32 and a higher mNIS+7 score indicates poorer function
- Neuropathy symptoms and change (NCS) scoreFrom diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years
NSC score is a questionnaire composed of 38 questions that assess the presence and severity of these neuropathy symptoms. The NSC score ranges from -114 to 114 for males and -108 to 108 for females. Greater scores indicate worse symptom severity; a negative value indicates an improvement in symptom severity from baseline
- PND (Polyneuropathy Disability)From diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years
The PND is a 6-stage scoring system: Stage 0: no impairment; Stage 1: sensory disturbances but preserved walking capabilities; Stage 2: impaired walking capacity, but ability to walk without a stick or crutches; Stage 3A/B: walking with help of 1 or 2 sticks or crutches; Stage 4: confined to wheel chair or bedridden. A greater stage indicates greater impairment
- Other relevant clinical measurement of ATTR amyloidosis functional statusFrom diagnosis of ATTR amyloidosis (index date), assessed throughout the study until end of follow-up, up to a maximum of 12 years
Any other relevant clinical measurement of ATTR amyloidosis functional status