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Detailed Assessment of Right Ventricle Function and Amyloid Burden using Novel Cardiac MRI techniques for Effectively Monitoring Treatment Response in ATTR-CM Patients treated with Tafamidis®

Detailed Assessment of Right Ventricle Function and Amyloid Burden using Novel Cardiac MRI techniques for Effectively Monitoring Treatment Response in ATTR-CM Patients treated with Tafamidis® - TTR Amyloidosis Research ASPIRE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00029230
Enrollment
60
Registered
2023-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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 diagnosed with cardiac ATTR amyloidosis (wild type or hereditary form) treated with Tafamidis® receive cardiac MRI examinations at different time points. By novel MRI techniques, we

Sponsors

LMU München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age: > 18 years Diagnosis of cardiac ATTR amyloidosis (wild-type or hereditary form) All genders

Exclusion criteria

Exclusion criteria: Patients with contraindications for cardiac MRI: - non-eligible foreign bodies (e.g. very old pacemakers) - known high risk for severe allergic reaction to gadolinium contrast agent - severe renal insufficiency (GFR < 30ml/min) Prior treatment with Tafamidis®, Patisiran® or Inotersen® Refusal to give informed consent

Design outcomes

Primary

MeasureTime frame
Less than 3,5 increase in ECV after 24 months when compared to baseline. Changes in following cardiac parameters after 6/12/24 months when compared to baseline: ECV, RV/LV function, RV/LV strain, etc.—

Secondary

MeasureTime frame
Differences in amyloid subtypes with regards to changes in ECV, RV/LV function, RV/LV strain, etc. Changes in the study patients quality of life over time—

Countries

Germany

Contacts

Public ContactClemens Cyran

LMU München

Clemens.Cyran@med.uni-muenchen.de+4989440076642

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026