NCT07494656

A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany

CHARACTERISTICS, SURVIVAL, HOSPITALIZATIONS AND EPIDEMIOLOGY IN ATTR-CM PATIENTS IN GERMANY: NATION-WIDE RETROSPECTIVE HEALTHCARE CLAIMS DATA ANALYSIS

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational study aims to describe the characteristics, health outcomes, and epidemiology of individuals diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM) in Germany. ATTR-CM is a rare and serious heart disease caused by the buildup of an abnormal protein called transthyretin in the heart muscle. This can lead to heart failure and other cardiovascular complications. This is a retrospective, non-interventional study based on anonymized statutory health insurance claims data from Germany. The study includes adults with a new diagnosis of ATTR-CM identified between 2020 and 2022. Data from both inpatient and outpatient healthcare settings are analyzed. No participants are recruited, and no medical treatments, procedures, or study visits are assigned as part of this study. The study will describe overall survival, cardiovascular-related hospitalizations, and the incidence of ATTR-CM in Germany. A predefined subgroup of individuals with at least one documented prescription for tafamidis will be analyzed separately to describe outcomes in this population. In addition, the study will examine the use of genetic testing after diagnosis and describe patient characteristics, as observed in routine clinical care. By using nationwide healthcare data, this study aims to provide a comprehensive and recent real-world overview of ATTR-CM in Germany and to support a better understanding of the disease.

Conditions

• ATTR-CM (Transthyretin Amyloid Cardiomyopathy)

Interventions

Type	Name	Description
OTHER	tafamidis 61mg (based on prescription data)	As provided in real world practice

Timeline

• Start date: 2026-03-31
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2026-03-27
• Last updated: 2026-03-27