ATTR Amyloidosis in Elderly Patients With Aortic Stenosis

Amyloidosis Cardiac Clinical Trial

Official title:

ATTR Amyloidosis in Elderly Patients With Aortic Stenosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04061213
• Other study ID #: 4083 / KEK-Nr. 2019-00880
• Status: Active, not recruiting
• Start date: August 26, 2019
• Est. completion date: December 2022

Study information

• Verified date: December 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 489
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Amyloidosis Cardiac
• Aortic Stenosis Symptomatic
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Diagnostic Test:
• Tc-99m-DPD scintigraphy
Myocardial scintigraphy

Locations

Country	Name	City	State
Switzerland	University Hospital Bern - Inselspital	Bern	BE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with grade 2 or 3 cardiac uptake in scintigraphy and without pathological light chains in immunological assays	Evaluation of incidence rate	In-Hospital [7 days]
Secondary	All-cause and cardiovascular mortality	Clinical Endpoints	30 days, 12months
Secondary	CPET - maximal exercise capacity	Functional Endpoints	In-Hospital [7 days]