Clinical Trials Directory

Trials / Unknown

UnknownNCT04061213

ATTR Amyloidosis in Elderly Patients With Aortic Stenosis

Status
Unknown
Phase
Study type
Observational
Enrollment
489 (actual)
Sponsor
Insel Gruppe AG, University Hospital Bern · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTTc-99m-DPD scintigraphyMyocardial scintigraphy

Timeline

Start date
2019-08-26
Primary completion
2022-12-01
Completion
2022-12-01
First posted
2019-08-19
Last updated
2022-12-15

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04061213. Inclusion in this directory is not an endorsement.