Screening for Amyloidosis Before Aortic Valve Elective Replacement

Active, not recruiting

• Conditions: Amyloidosis; Aortic Valve Stenosis
• Interventions: Other: The outcome of an intervention is not evaluated, but aortic stenosis and additional amyloidosis are compared.

• Registration Number: NCT04869631
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Previous studies detected that up to 15% of patients undergoing aortic valve replacement (AVR) for degenerative aortic stenosis have concomitant transthyretin amyloidosis (ATTR) cardiomyopathy (Castano, 2017). The aim of this study is to investigate the effectivity and practicability of a systematic ATTR-Screening in patients undergoing planned AVR. Moreover, we plan to develop a screening algorithm to detect ATTR in aortic stenosis (AS).

Detailed Description

Untreated cardiac amyloidosis is accompanied with an impaired prognosis. Amyloidosis is often associated with ventricular hypertrophy which leads to severe heart failure and occurs frequently in conjunction with bradycardic or tachycardic malignant arrhythmia. Patients with degenerative aortic valve stenosis suffer more frequently from cardiac ATTR. However, it remains unclear whether the development of aortic stenosis is promoted by ATTR. Due to very similar symptoms (shortness of breath during physical exertion, reduced walking distance) diagnosis of aortic valve stenosis is more often diagnosed in a typical cohort of patients aged between 70-80 years but, in contrast, leads to underdiagnosis of patients with additional cardiac amyloidosis. Six to fifteen percent of patients with aortic valve replacement due to degenerative aortic valve stenosis exhibit a cardiac amyloidosis. Since cardiac amyloidosis without therapeutic intervention is associated with significantly reduced life expectancy, it can be assumed that these patients will not benefit to the same extent from the AVR alone as patients without ATTR. New therapeutic approaches for patients exhibiting ATTR lead to a reduction of mortality and hospitalizations. The primary aim of this study is to establish a simple ATTR screening tool in patients with planned AVR in the clinical routine and, furthermore, to compare the clinical course following AVR between patients with and without ATTR.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-03
• Primary Completion: 2023-03-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• age ≥40 years
• written informed consent from the patient or of his/her legal guardian
• hospitalization for AVR due to degenerative aortic valve stenosis

Exclusion Criteria

• hemodynamically unstable patient
• severe co-morbidities with an estimated life expectancy of <1 year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aortic valve stenosis undergoing aortic valve replacement	The outcome of an intervention is not evaluated, but aortic stenosis and additional amyloidosis are compared.	Aortic valve stenosis undergoing aortic valve replacement.

Primary Outcome Measures

Name	Time	Method
Number/ proportion of ATTR cases identified by systematic screening	Enrolment period: 18 months

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany