Early Detection of Cardiac Amyloidosis

NCT05010980 | Unknown

• 1 other identifier: 21-002
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Due to a lack of therapeutic options, the diagnosis of cardiac (wt)-ATTR amyloidosis was for a long time overshadowed by other diseases and therefore was or still is often diagnosed with considerable delay. The aim of the study is to estimate the prevalence of cardiac amyloidosis among patients with mild-to-moderate aortic valve stenosis (AS). Besides that a screening algorithm based on echocardiographic parameters will be developed, to facilitate the early detection of cardiac amyloidosis.

Conditions

Amyloidosis; Aortic Valve Stenosis

Keywords

Amyloidosis; Aortic Valve Stenosis; MRI; myocardial scintigraphy; screening algorithm; early detection

Outcome Measures

Primary Outcomes (1)

• prevalence of cardiac amyloidosis in mild-to-moderate AS

  estimating the prevalence of cardiac amyloidosis

  up to two years

Secondary Outcomes (1)

• frequency of more rapid progression of AS in patients with cardiac amyloidosis than those without

  up to two years

Study Arms (2)

retrospective

For the retrospective part of the study, the existing echocardiographic database will be used to retrieve data. The database query includes the last 2 years.

Other: CMR; Other: scintigraphy

prospective

For the prospective part of the study, patients will be included who have the clinical indication for cmr and scintigraphy due to suspected cardiac amyloidosis and fulfill the inclusion criteria.

Other: CMR; Other: scintigraphy

Interventions

CMR OTHER

clinical indication

prospective; retrospective

scintigraphy OTHER

clinical indication

prospective; retrospective

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing a routine echocardiographic assessment which results in the clinical indication for CMR and scintigraphy among patients with aortic valve stenosis

You may qualify if:

• Age \> 65 years
• Patients who fulfill at least 3 of the following 4 criteria based on cardiac ultrasound examination, which results in the clinical indication for CMR and scintigraphy
• Evidence an aortic valve stenosis, defined as opening area according to velocity time integral (VTI) \< 2cm2
• Hypertrophy of the interventricular septum (IVS) \> 11mm
• Echocardiographically assesed reduced stroke volume index (SVI) (\< 35 ml/m2)
• Reduced ratio of electrical signals of the heart (in the ECG) to the mass of the heart muscle (\< 1.6 \*10-2 mV/g/m2)

You may not qualify if:

• Patients who are incapable of giving consent,
• Age \< 65 years
• patients who have not given their written consent

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Division of Cardiology, Pulmonary Diseases and Vascular Medicine

Düsseldorf, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Amyloidosis; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Ralf Westenfeld, MD

  Division. of Cardiology, Pulmonary Disease and Vascular Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralf Westenfeld, MD

CONTACT

0049211 8118800; ctu@med.uni-duesseldorf.de

Timm Alicja, MSc

CONTACT

0049 2118105314; ctu@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 18, 2021
• Study Start: August 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

DE (1)