Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651073
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
ATTR-CM A Multi-country Non-interventional Disease Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Real-World Characteristics and Treatment Patterns of Patients With Transthyretin Amyloid Cardiomyopathy ATTR-CM A Multi-Country Non-Interventional Disease Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multi-center non-interventional disease registry to characterize the natural history of ATTR-CM and treatment patterns in clinically diagnosed ATTR-CM patients Data will be collected in the course of routine clinical practice or following local standard practice guidelines No procedures or treatments will be mandated by this study patients will receive usual clinical care
The patient population will include all adult patients with a confirmed diagnosis of ATTR-CM after 01 June 2019 and who meet eligibility criteria The index date of each patient will be the date of the first documented ATTR-CM diagnosis The observation period for each patient will range from the index date to whichever occurs first of death patient withdrawal of consent loss to follow-up or end of data collection The end of data collection ie the end of study is planned for 12 months after the end of the enrollment period
As this study is descriptive in nature with no hypothesis testing the study size will be based on the number of eligible ATTR-CM cases identified in the medical records and meeting the eligibility criteria Approximately 350 patients diagnosed with ATTR-CM across approximately 17 sites in Taiwan Hong Kong and Malaysia are planned to be enrolled
The patient population will include all adult patients with a confirmed diagnosis of ATTR-CM after 01 June 2019 and who meet eligibility criteria The index date of each patient will be the date of the first documented ATTR-CM diagnosis The observation period for each patient will range from the index date to whichever occurs first of death patient withdrawal of consent loss to follow-up or end of data collection The end of data collection ie the end of study is planned for 12 months after the end of the enrollment period
As this study is descriptive in nature with no hypothesis testing the study size will be based on the number of eligible ATTR-CM cases identified in the medical records and meeting the eligibility criteria Approximately 350 patients diagnosed with ATTR-CM across approximately 17 sites in Taiwan Hong Kong and Malaysia are planned to be enrolled
Detailed Description:
Study variables will include demographic and clinical characteristics of the ATTR-CM patients at diagnosis including age sex physical measurement relevant medical history and comorbidities New York Heart Association NYHA functional class prior prescription of heart and CV medication type of ATTR-CM ATTRwt or ATTRm and diagnosis parameters Exposure variables will include treatment type treatment regimenpatterns and concomitant medications Outcome variables will provide information on death status and reasons hospitalizations status and reasons imaging and lab assessments Kansas City Cardiomyopathy Questionnaire KCCQ and healthcare resource utilization eg days of hospitalization frequency of emergency department visits All relevant data will be collected from the index date to the end of the observation period
Data will be obtained from all information that is available at the site in the patients electronic medical records and medical charts eg consultation notes discharge summaries laboratory test results recorded prescription data and any other documentation of communication with other health care providers All data will be collected by trained site personnel and entered directly into web-based electronic case report forms eCRFs
Data will be obtained from all information that is available at the site in the patients electronic medical records and medical charts eg consultation notes discharge summaries laboratory test results recorded prescription data and any other documentation of communication with other health care providers All data will be collected by trained site personnel and entered directly into web-based electronic case report forms eCRFs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None