Skip to content
DataLookout
Start free
Menu

NCT07494656

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

StatusActive, Not Recruiting
PhaseNot specified
SponsorPfizer
Primary completion (estimated)

At risk: Primary completion moved 5 months later across 2 updates.

See at-risk trials from Pfizer

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 5 versions: 5 with changes below.

  1. Primary and study completion pushed from Sep 30, 2026 to Nov 30, 2026
  2. Primary and study completion pushed from Jun 30, 2026 to Sep 30, 2026v4
  3. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary and study completion pushed from Apr 30, 2026 to Jun 30, 2026
    • Site details revised
    v3
  4. Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 31, 2026 to Apr 2, 2026
    v2
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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

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

Arms and interventions

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.

Other: tafamidis 61mg (based on prescription data)

Sites

1 site in 1 country

  • PfizerBerlin, Germany