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NCT Number: NCT07494656

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

ATTR-CM (Transthyretin Amyloid Cardiomyopathy)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tafamidis 61mg (based on prescription data)

Other

As provided in real world practice

Primary outcomes

  1. Overall Survival in Individuals With Incident Transthyretin Amyloid Cardiomyopathy (ATTR-CM), Overall and in Those With at Least One Tafamidis Prescription

    Time frame: From incident ATTR-CM diagnosis (Index 1) until death, end of SHI enrollment, or end of data availability (December 31, 2023). For those with at least one tafamidis prescription, additionally from first tafamidis prescription (Index 2).

  2. Cardiovascular-Related Hospitalizations in Individuals With Incident Transthyretin Amyloid Cardiomyopathy (ATTR-CM), Overall and in Those With at Least One Tafamidis Prescription

    Time frame: From incident ATTR-CM diagnosis (Index 1) until death, end of SHI enrollment, or end of data availability (December 31, 2023). For those with at least one tafamidis prescription, additionally from first tafamidis prescription (Index 2).

Secondary outcomes

  1. Annual Incidence of Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in Germany

    Time frame: Calendar years 2020, 2021, and 2022

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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