Epidemiology and outcomes of transthyretin amyloid cardiomyopathy in Germany

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

This project uses anonymous German health insurance records to see if researchers can describe how often adults newly diagnosed with ATTR‑CM (2020–2022) experience outcomes like survival, hospitalizations, and use of treatments such as tafamidis.

Quick facts

• Study type: Observational
• Enrollment: 1 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pfizer (Industry-sponsored)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Berlin)
• Trial ID: NCT07494656 on ClinicalTrials.gov

What this trial studies

This is a retrospective, non‑interventional analysis of anonymized statutory health insurance claims data from Germany covering adults with a new ATTR‑CM diagnosis between January 2020 and December 2022. A validated claims-based algorithm identifies cases using inpatient and outpatient diagnosis codes and evidence of cardiac involvement, and individuals with signs of light‑chain (AL) amyloidosis are excluded. The study reports incidence, overall survival, cardiovascular-related hospitalizations, and healthcare utilization, and includes a predefined subgroup with at least one recorded prescription of tafamidis 61 mg. No patients are recruited and no treatments or study visits are assigned as part of this work.

Who should consider this trial

Good fit: The records analyzed represent adults (age ≥18) in Germany with a newly identified ATTR‑CM diagnosis between 2020 and 2022 who had continuous statutory health insurance enrollment meeting the study's look‑back and follow‑up requirements.

Not a fit: People with light‑chain (AL) amyloidosis, individuals diagnosed outside the 2020–2022 window, and those not continuously covered by German statutory health insurance are not represented and are unlikely to benefit from these specific findings.

Why it matters

Potential benefit: If successful, this work could clarify how common ATTR‑CM is in Germany and how patients fare over time, helping clinicians and health systems plan care and resources.

How similar studies have performed: Similar retrospective claims and registry analyses in other countries have produced useful epidemiologic and outcome data for ATTR‑CM, but Germany‑specific claims analyses are relatively limited, giving this work novel local value.

Eligibility criteria

Inclusion Criteria:

Adults aged 18 years or older at the time of the index date

Individuals with a newly identified transthyretin amyloid cardiomyopathy (ATTR-CM) diagnosis between January 2020 and December 2022, identified using a validated claims-based algorithm

Evidence of amyloidosis, defined as:

At least one inpatient diagnosis or At least two outpatient diagnoses in separate quarters

Evidence of cardiac involvement, defined as at least one diagnosis of cardiomyopathy or heart failure occurring within a defined temporal window before or after the amyloidosis diagnosis

Continuous enrollment in German statutory health insurance for:

At least 8 quarters prior to the index date, and At least 4 consecutive quarters after the index date (or until death)

Exclusion Criteria:

Evidence of light-chain (AL) amyloidosis, including:

AL-specific treatment prescriptions Chemotherapy associated with amyloidosis Diagnosis of multiple myeloma autologous stem cell transplantation

Diagnosis of amyloid angiopathy

Prior amyloidosis diagnosis during the 2-year wash-out period before the index date Missing or implausible information on sex

Additional Criteria for Tafamidis Subgroup At least one prescription of tafamidis 61 mg during follow-up No prescriptions for other disease-modifying therapies for transthyretin amyloidosis with polyneuropathy

Where this trial is running

Berlin

• Pfizer — Berlin, Germany (Recruiting)

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions ATTR-CM