Clinical trial NCT06015997: Prevalence of ATTR Cardiac Amyloidosis in Patients Undergoing TAVR
Official title: The Prevalence of ATTR Cardiac Amyloidosis in Elderly Middle Eastern Patients Undergoing Transarterial Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ATTR Amyloidosis Wild Type
Severe Aortic Stenosis
Aortic Valve Stenosis
Middle East Studies
Keywords: ATTR cardiac amyloidosis
Severe aortic stenosis
Transarterial aortic valve replacement
Lead sponsor: Jordan Collaborating Cardiology Group
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive elderly patients, 65 years of age or older, with a diagnosis of severe aortic stenosis who undergo TAVR will be evaluated for the possible diagnosis of an underlying ATTR cardiac amyloidosis.

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.

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.

Primary outcomes:
measure: Prevalence of ATTR CA in TAVR patients
timeFrame: On admission ( from time of admission to time of discharge from the hospital) and within 10 days.
measure: Cardiovascular event at One year follow up
timeFrame: One year after enrollment: up to 30 days after the passage of 365 days after the TAVR procedure
Secondary outcomes:
Other outcomes:
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