ATTR-CM: A Multi-country, Non-interventional Disease Registry

Phase

N/A

Condition

Amyloidosis

Treatment

Observational

Clinical Study ID

NCT06651073

B3461110

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Evidence of a personally signed and dated informed consent document indicating thatthe patient (or a legally acceptable representative) has been informed of allpertinent aspects of the study. Waivers of informed consent for deceased patientswill be pursued if permitted by local regulation
Patients aged ≥18 years at first ATTR-CM diagnosis
Patients with confirmed diagnosis of ATTR-CM after 01 June 2019

Exclusion

Exclusion Criteria:

None

Study Design

Observational

October 01, 2024

April 28, 2028

Study 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 regimen/patterns, 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).

Connect with a study center

National Taiwan University
Taipei 1668341, 100225
Taiwan
Site Not Available
National Taiwan University
Taipei City, 100225
Taiwan
Site Not Available

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