Prevalence of ATTR Cardiac Amyloidosis in Patients Undergoing TAVR

NCT ID: NCT06015997

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-11-01

Brief Summary

ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (AS). The reasons for this association are not fully known. It is hypothesized that an amyloidotic infiltration of the aortic valve acts as a trigger for the development of endothelial damage and subsequent calcification. Elderly patients undergoing TAVI will be evaluated for the presence of ATTR-CA in Jordan.

Detailed Description

ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (AS). The reasons for this association are not fully known. Two hypotheses may explain this association

1. Amyloidotic infiltration of the aortic valve acts as a trigger for the development of endothelial damage and subsequent calcification.

2. The increased myocardial strain induced by AS may locally favor the process of amyloidogenesis and tissue infiltration.

Transarterial AV replacement (TAVI) is the treatment of choice for elderly patients with severe calcific AS. Studies have shown a prevalence of about 10% of ATTR cardiac amyloidosis in patients undergoing TAVI. The diagnosis is based on a positive nuclear scan (PYP, DPD or HMDP) and ruling out AL amyloidosis in patients with positive scans. While studies have shown no impact of ATTR on prognosis in TAVI patients, there is evidence of poorer quality of life, increased in-hospital acute ischemic stroke, increased cardiac and heart failure hospitalizations, increased conduction abnormalities, compared to patients without ATTR undergoing TAVI.

The prevalence of ATTR in TAVI patients in Jordan and Middle Eastern populations has not been previously evaluated. The purpose of this study is to evaluate the prevalence of ATTR cardiac amyloidosis in elderly Middle Eastern patients undergoing TAVI and to document the clinical characteristics, procedural outcomes and 1 year follow up of such patients compared to patients without ATTR.

Conditions

ATTR Amyloidosis Wild Type; Severe Aortic Stenosis; Aortic Valve Stenosis; Middle East Studies

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age ≥65 years
• Severe aortic stenosis
• Patient underwent TAVR procedure
• Positive pyruvate PO4 scan

Exclusion Criteria

• Diagnosis of AL amyloidosis base on free light chain assay, serum and urine immune electrophoresis.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jordan Collaborating Cardiology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ramzi Tabbalat, MD, FACC

Role: CONTACT

ramzi_md@yahoo.com

00962795535522

Other Identifiers

ANAC.JO.2023.ATTR.TAVR.ME

Identifier Type: -

Identifier Source: org_study_id