Prevalence of ATTR Cardiac Amyloidosis in Patients Undergoing TAVR

Aortic Valve Stenosis Clinical Trial

Official title:

The Prevalence of ATTR Cardiac Amyloidosis in Elderly Middle Eastern Patients Undergoing Transarterial Aortic Valve Replacement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06015997
• Other study ID #: ANAC.JO.2023.ATTR.TAVR.ME
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: August 2023
• Source: Jordan Collaborating Cardiology Group
• Contact: Ramzi Tabbalat, MD, FACC
• Phone: 00962795535522
• Email: ramzi_md[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 1, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyloidosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Severe Aortic Stenosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jordan Collaborating Cardiology Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of ATTR CA in TAVR patients	Consecutive elderly (=65 years) patients who are undergoing TAVI will be included.; Patients will be invited to undergo a pyruvate PO4 (PYP) scan. Patients with positive scans will undergo further testing to rule out AL amyloidosis (Free light chain assay, SIFEP, UIFEP). Data collection will include all pertinent clinical characteristics, peri- procedural details.	On admission ( from time of admission to time of discharge from the hospital) and within 10 days.
Primary	Cardiovascular event at One year follow up	Events at one year defined as the occurrence of all-cause death, and hospital admission for heart failure or aortic valve reintervention.	One year after enrollment: up to 30 days after the passage of 365 days after the TAVR procedure