ATTR-CM (Transthyretin Amyloid Cardiomyopathy)NCT07494656
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
An observational study of ATTR-CM (Transthyretin Amyloid Cardiomyopathy), run by Pfizer at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
- What is being tested?
- tafamidis 61mg (based on prescription data)
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- 2 Apr 2026to 30 Sep 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adults insured under the German statutory health insurance system who were newly identified with transthyretin amyloid cardiomyopathy (ATTR-CM) between 2020 and 2022.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CHARACTERISTICS, SURVIVAL, HOSPITALIZATIONS AND EPIDEMIOLOGY IN ATTR-CM PATIENTS IN GERMANY: NATION-WIDE RETROSPECTIVE HEALTHCARE CLAIMS DATA ANALYSIS
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.
Read more
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.
- Being tested
- tafamidis 61mg (based on prescription data)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tafamidis 61mg (based on prescription data)Other
As provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| Patients with incident transthyretin amyloid cardiomyopathy (ATTR-CM) in Germany | Adult patients (≥18 years) with incident transthyretin amyloid cardiomyopathy (ATTR-CM) in Germany, identified using a claims-based algorithm in nationwide statutory health insurance data. Incident cases are defined based on a washout period of at least two years without prior amyloidosis diagnosis. Patients are followed from the date of ATTR-CM diagnosis. Subset of the incident ATTR-CM population with at least one documented prescription of tafamidis 61 mg during follow-up will be included. Receives: Other: tafamidis 61mg (based on prescription data) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival in Individuals With Incident Transthyretin Amyloid Cardiomyopathy (ATTR-CM), Overall and in Those With at Least One Tafamidis Prescription
Measured: 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).
Cardiovascular-Related Hospitalizations in Individuals With Incident Transthyretin Amyloid Cardiomyopathy (ATTR-CM), Overall and in Those With at Least One Tafamidis Prescription
Measured: 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
Measured: Calendar years 2020, 2021, and 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start2 Apr 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ATTR-CM (Transthyretin Amyloid Cardiomyopathy)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494656
- Sponsor's protocol ID
- B3461130
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.