ATTR Amyloidosis in Elderly Patients With Aortic Stenosis
Study Details
Study Description
Brief Summary
Severe aortic stenosis is defined with a mean transvalvular pressure gradient (MTPG) > 40mmHg and a calculated aortic valve area of < 1cm2. However, a considerable proportion of patients do have a MTPG < 40mmHg due to a reduced stroke volume (stroke volume indexed to body surface area ≤ 35ml/m2) despite a normal left ventricular ejection fraction (LVEF > 50%). This entity is termed paradoxical low flow low gradient aortic stenosis (PLFLG AS) and is associated with a worse prognosis.
ATTR amyloidosis is a disease of the elderly and might coexist in patients with severe aortic stenosis. Case reports and small observational studies suggest that senile ATTR amyloidosis could be frequent but underdiagnosed in patients with aortic stenosis. There is significant overlap between PLFLG AS and cardiac amyloidosis with regard to symptoms, increasing prevalence with age, concentric hypertrophy, impaired diastolic filling of the left ventricle (LV), as well as longitudinal LV dysfunction despite preserved ejection fraction - all features, which lead to a reduction in stroke volume, the underlying mechanism of the low flow condition as observed in PLFLG AS patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with symptomatic severe aortic stenosis Elderly patients referred for TAVR evaluation |
Diagnostic Test: Tc-99m-DPD scintigraphy
Myocardial scintigraphy
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with grade 2 or 3 cardiac uptake in scintigraphy and without pathological light chains in immunological assays [In-Hospital [7 days]]
Evaluation of incidence rate
Secondary Outcome Measures
- All-cause and cardiovascular mortality [30 days, 12months]
Clinical Endpoints
- CPET - maximal exercise capacity [In-Hospital [7 days]]
Functional Endpoints
Eligibility Criteria
Criteria
Inclusion Criteria:
- Symptomatic, severe aortic stenosis
Exclusion Criteria:
-
More than mild valvular disease of any other valve
-
Other severe disease with a life expectancy < 1 year
-
Participating in trial interfering with routine clinical practice or use of a non-CE marked device
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Bern - Inselspital | Bern | BE | Switzerland | 3010 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
Investigators
- Principal Investigator: Stefan Stortecky, MD, Swiss Cardiovascular Center Bern
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4083 / KEK-Nr. 2019-00880