Active not recruitingOBSERVATIONAL

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

This study is like looking back at existing health records in Germany to learn more about a rare, serious heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). This condition happens when an unusual protein builds up in the heart, leading to heart failure. Researchers are studying information from general health insurance data between 2020 and 2022 to understand how common ATTR-CM is, how people with it are affected over time, and how often they need to go to the hospital. They're also looking at what kind of health checks patients receive and the use of a specific medicine called tafamidis. This study doesn't involve new patients or treatments; it simply uses anonymous data to get a clearer picture of ATTR-CM in real-life situations.

At a glance

Status

Active not recruiting

Sponsor

Pfizer

Enrolment target

Start

02 Apr 2026

Estimated completion

30 Jun 2026

ATTR-CM (Transthyretin Amyloid Cardiomyopathy)

What is this study about?

Imagine you have a rare heart condition called ATTR-CM. This condition happens when a special protein in your body doesn't work quite right and builds up in your heart. Over time, this build-up can make your heart muscle stiff and not pump blood as well as it should, leading to symptoms like tiredness, swelling, and shortness of breath – often called heart failure. Because ATTR-CM is rare, doctors want to learn as much as they can to help people living with it.

This study is like a detective looking at existing health information from many people in Germany who have been diagnosed with ATTR-CM. It's not a study where people receive new treatments or have to go for extra tests. Instead, the researchers are using records from health insurance companies between 2020 and 2022. They want to understand things like how often people with ATTR-CM need to stay in hospital because of their heart condition, how long people generally live after being diagnosed, and if they have genetic tests to understand their condition better.

They are also particularly interested in a group of these patients who were prescribed a specific medicine called tafamidis. By looking at anonymous data, they hope to get a full picture of ATTR-CM in Germany. This helps doctors and scientists better understand the condition and how it affects people in the real world, which can lead to better care and support in the future.

Key takeaways

It's a look-back study using existing, anonymous health records.
It aims to understand a rare heart disease called ATTR-CM in Germany.
No patients are actively involved; no new treatments or tests are given.
It helps researchers learn about ATTR-CM's impact, how common it is, and genetic testing.
It also looks at the use of a medicine called tafamidis for this condition.
The goal is to improve understanding and future care for ATTR-CM patients.

Who may be eligible?

This study looks at information from adults in Germany, aged 18 or older, who were first diagnosed with ATTR-CM between January 2020 and December 2022. To be included, their health records must clearly show they have both amyloidosis (the protein build-up) and heart problems related to it.

Also, they need to have been continuously covered by German health insurance for at least two years before their diagnosis and for at least one year afterwards (or until they passed away). This ensures there's enough health information to study properly.

People were not included if their records suggested a different type of amyloidosis (called AL amyloidosis), or if they had certain other conditions like amyloid affecting the brain, or if they had been diagnosed with amyloidosis two years before the study started. The study also excluded records with missing important information like gender. For the specific part of the study looking at tafamidis, individuals are included if their records show they received this medicine and not other similar treatments for nerve-related amyloidosis.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged 18 or older?
Were you diagnosed with ATTR-CM between 2020 and 2022?
Do your records show evidence of both amyloidosis and heart problems?
Have you been continuously covered by German health insurance for specific periods?
Do you not have a different type of amyloidosis (AL amyloidosis)?

Answer every question to see your result.

What does participation involve?

You don't need to do anything to take part in this study. This is an "observational" study, meaning researchers are simply looking at existing, anonymous health information that has already been collected. No new visits to the doctor, no extra tests, no changes to your medication, and no special follow-up appointments are required. Your health records are used without identifying you personally. It's like researchers looking at a library of health books, but without knowing who wrote each book.

Potential risks and benefits

There are no direct benefits or risks to individuals from this study, as no one is actively participating or receiving any treatment. The study uses anonymous existing health data, meaning your personal identity is protected. The main benefit is that the findings could help doctors and researchers better understand ATTR-CM. This improved understanding could potentially lead to better care and treatments for patients with ATTR-CM in the future. As you are not directly involved, there is no need to 'withdraw' from the study.

Locations (1)

Pfizer
Verified postcode
Berlin, Germany

Common questions

What is ATTR-CM?

ATTR-CM is a rare heart condition where an abnormal protein builds up in the heart muscle, making it stiff and causing heart problems.

Am I taking part in this study?

No, this study uses existing, anonymous health records from Germany. No one is actively recruited or directly participates.

Will my personal health information be shared?

No, the study uses anonymous data. Your personal identity and specific health information will not be shared or known to the researchers.

What is tafamidis?

Tafamidis is a medicine that can be used to treat ATTR-CM. This study is looking at how it's used in real life.

Why is this study important?

It helps doctors learn more about ATTR-CM, how common it is, and how it affects patients, which can improve future care.