ATTR Amyloidosis in Elderly Patients With Aortic Stenosis

Active, not recruiting

• Conditions: Aortic Stenosis Symptomatic; Amyloidosis Cardiac
• Interventions: Diagnostic Test: Tc-99m-DPD scintigraphy

• Registration Number: NCT04061213
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-19
• Study Start: 2019-08-26
• Status Verified: 2022-12
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 489

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with symptomatic severe aortic stenosis	Tc-99m-DPD scintigraphy	Elderly patients referred for TAVR evaluation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
All-cause and cardiovascular mortality	30 days, 12months	Clinical Endpoints
CPET - maximal exercise capacity	In-Hospital [7 days]	Functional Endpoints

Trial Locations

Locations (1)

University Hospital Bern - Inselspital; 🇨🇭 Bern, BE, Switzerland