Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04869631

Screening for Amyloidosis Before Aortic Valve Elective Replacement

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The outcome of an intervention is not evaluated, but aortic stenosis and additional amyloidosis are compared.

Other

We aim to compare patients with aortic valve stenosis with and without cardiac amyloidosis.

Primary outcomes

  1. Number/ proportion of ATTR cases identified by systematic screening

    Time frame: Enrolment period: 18 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Deutsches Herzzentrum Berlin, Klinik für Innere Medizin - Kardiologie
  • Klinik für Neurologie mit Experimenteller Neurologie, Charité - Universitätsmedizin Berlin

Registry information

Official study title

Screening for Amyloidosis Before Aortic Valve Elective Replacement (SAVER)

Acronym: SAVER

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
May 3, 2021
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.