Screening for Amyloidosis Before Aortic Valve Elective Replacement

NCT04869631 | Active Not Recruiting

• 1 other identifier: EA4/235/20
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Amyloidosis; Aortic Valve Stenosis

Keywords

Cardiac Amyloidosis; Transthyretin Amyloidosis; ATTR; Aortic Stenosis; Screening

Outcome Measures

Primary Outcomes (1)

• Number/ proportion of ATTR cases identified by systematic screening

  Enrolment period: 18 months

Study Arms (1)

Aortic valve stenosis undergoing aortic valve replacement

Aortic valve stenosis undergoing aortic valve replacement.

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

Interventions

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.

Aortic valve stenosis undergoing aortic valve replacement

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Deutsches Herzzentrum Berlin, Klinik für Innere Medizin - Kardiologie: collaborator
• Klinik für Neurologie mit Experimenteller Neurologie, Charité - Universitätsmedizin Berlin: collaborator

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (3)

• 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.

  PMID: 30145929 BACKGROUND

• Kerr D. Lin zhong guan huai: terminal care in China. Am J Hosp Palliat Care. 1993 Jul-Aug;10(4):18-26. doi: 10.1177/104990919301000407. No abstract available.

  PMID: 7687139 BACKGROUND

• Amramy A. Waste treatment for ground water recharge. Air Water Pollut. 1965 Oct;9(10):605-19. No abstract available.

  PMID: 5837725 BACKGROUND

Related Links

• Amyloidosis center of the Charité

MeSH Terms

Conditions

Amyloidosis; Aortic Valve Stenosis; Amyloid Neuropathies, Familial; Amyloidosis, Hereditary, Transthyretin-Related

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project lead

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: February 1, 2021
• Primary Completion: March 31, 2023
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)