Comparison of imaging-based treatment effects of tafamidis versus acoramidis in patients with transthyretin amyloid cardiomyopathy (ATTR-CM)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039078

Enrollment

Registered

2026-01-23

Start date

2026-02-02

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E85.4

Interventions

Group 1: Patients with ATTR-CM receiving acoramidis therapy. This is an observational cohort study. No additional tests or treatments are performed for study purposes. Only data collected as part of r

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with a confirmed diagnosis of ATTR-CM receiving treatment with tafamidis or acoramidis and with a left ventricular ejection fraction (LVEF) = 45% will be included in the study. Availability of baseline and follow-up echocardiographic examinations with documented strain measurements (LV-GLS and left atrial strain) is required.

Exclusion criteria

Exclusion criteria: Patients will be excluded in case of a switch between study medications, suboptimal echocardiographic image quality, or absence of strain analyses at both required time points.

Design outcomes

Primary

Measure	Time frame
Primary project objective: This cohort study with a longitudinal comparison aims to identify potential differences in myocardial remodeling behavior under tafamidis versus acoramidis therapy. To this end, changes in LV global longitudinal strain (LV-GLS) and left atrial strain (LA strain) after 6 and 12 months of treatment will be compared. A direct clinical comparison of imaging-based treatment effects is highly relevant for evaluating the clinical efficacy and potential differences between the two agents.	—

Measure

Time frame

Primary project objective: This cohort study with a longitudinal comparison aims to identify potential differences in myocardial remodeling behavior under tafamidis versus acoramidis therapy. To this end, changes in LV global longitudinal strain (LV-GLS) and left atrial strain (LA strain) after 6 and 12 months of treatment will be compared. A direct clinical comparison of imaging-based treatment effects is highly relevant for evaluating the clinical efficacy and potential differences between the two agents.

—

Secondary

Measure	Time frame
Secondary parameters: Left ventricular wall thickness Mitral annular plane systolic excursion (MAPSE) and left ventricular ejection fraction (LVEF) Right ventricular function: fractional area change (FAC) and tricuspid annular plane systolic excursion (TAPSE) Pericardial effusion	—

Countries

Germany

Contacts

Public ContactCan Öztürk

Universitätsklinikum Bonn

can.oeztuerk@ukbonn.de+4922828725029

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026