Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04869631
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-03
First Post:
2021-04-28
Brief Title:
Screening for Amyloidosis Before Aortic Valve Elective Replacement
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Screening for Amyloidosis Before Aortic Valve Elective Replacement SAVER
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAVER
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None