MedDataX Logo

ATTR Amyloidosis in Elderly Patients With Aortic Stenosis

NCT ID: NCT04061213

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

489 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-26

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Stenosis Symptomatic Amyloidosis Cardiac

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with symptomatic severe aortic stenosis

Elderly patients referred for TAVR evaluation

Tc-99m-DPD scintigraphy

Intervention Type DIAGNOSTIC_TEST

Myocardial scintigraphy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tc-99m-DPD scintigraphy

Myocardial scintigraphy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stefan Stortecky, MD

Role: PRINCIPAL_INVESTIGATOR

Swiss Cardiovascular Center Bern

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Bern - Inselspital

Bern, Canton of Bern, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

Bernhard B, Leib Z, Dobner S, Demirel C, Caobelli F, Rominger A, Schutze J, Grogg H, Alwan L, Spano G, Boscolo Berto M, Lanz J, Pilgrim T, Windecker S, Stortecky S, Grani C. Routine 4D Cardiac CT to Identify Concomitant Transthyretin Amyloid Cardiomyopathy in Older Adults with Severe Aortic Stenosis. Radiology. 2023 Dec;309(3):e230425. doi: 10.1148/radiol.230425.

Reference Type DERIVED
PMID: 38085082 (View on PubMed)

Dobner S, Pilgrim T, Hagemeyer D, Heg D, Lanz J, Reusser N, Grani C, Afshar-Oromieh A, Rominger A, Langhammer B, Reineke D, Windecker S, Stortecky S. Amyloid Transthyretin Cardiomyopathy in Elderly Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation. J Am Heart Assoc. 2023 Aug 15;12(16):e030271. doi: 10.1161/JAHA.123.030271. Epub 2023 Aug 10.

Reference Type DERIVED
PMID: 37581394 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4083 / KEK-Nr. 2019-00880

Identifier Type: -

Identifier Source: org_study_id