Clinical trial NCT04869631: Screening for Amyloidosis Before Aortic Valve Elective Replacement
Official title: Screening for Amyloidosis Before Aortic Valve Elective Replacement (SAVER)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Amyloidosis
Aortic Valve Stenosis
Keywords: Cardiac Amyloidosis
Transthyretin Amyloidosis
ATTR
Aortic Stenosis
Screening
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Deutsches Herzzentrum Berlin, Klinik für Innere Medizin - Kardiologie
name: Klinik für Neurologie mit Experimenteller Neurologie, Charité - Universitätsmedizin Berlin
First posted: 2021-05-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \>40 years with aortic valve stenosis who are scheduled to undergo interventional or surgical aortic valve replacement at Deutsches Herzzentrum Berlin or Charité - Universitätsmedizin Berlin during a recruiting period of 18 months; in total approximately 1500 patients.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number/ proportion of ATTR cases identified by systematic screening
timeFrame: Enrolment period: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
References:
citation: Maurer MS, Schwartz JH, Gundapaneni B, Elliott PM, Merlini G, Waddington-Cruz M, Kristen AV, Grogan M, Witteles R, Damy T, Drachman BM, Shah SJ, Hanna M, Judge DP, Barsdorf AI, Huber P, Patterson TA, Riley S, Schumacher J, Stewart M, Sultan MB, Rapezzi C; ATTR-ACT Study Investigators. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018 Sep 13;379(11):1007-1016. doi: 10.1056/NEJMoa1805689. Epub 2018 Aug 27.
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