Early Detection of Cardiac Amyloidosis

  • STATUS
    Recruiting
  • End date
    Sep 26, 2023
  • participants needed
    400
  • sponsor
    Heinrich-Heine University, Duesseldorf
Updated on 26 August 2021
stenosis
cardiac amyloidosis
aortic valve stenosis

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.

Description

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. On the one hand, it was assumed that the number of cases was significantly lower than the latest studies showed, and on the other hand, until the introduction of new therapeutic agents, there was no approved therapeutic option available, so that the corresponding diagnosis did not result in any therapeutic consequences.

This has changed fundamentally in recent years. For example, analyses of patients who underwent interventional aortic valve replacement (TAVI) as a result of high-grade AS demonstrated cardiac amyloidosis in up to 16% of these patients. Patients with (paradoxical) low flow low gradient (lflg) AS, which is echocardiographically characterized by a low stroke volume index (SVI), are particularly frequently affected. In light of these data, recent publications recommend the use of a low SVI, in conjunction with ECG criteria (low Sokolow-Lyon index) relative to echocardiographically determined left ventricular myocardial mass (SLI/ LVM) as a screening tool for the presence of amyloidosis in the patient population with high-grade aortic valve stenosis.

In patients with mild-to-moderate AS, the prevalence of amyloidosis and the validity of these methods has not yet been clarified. However, identification of these would be, of particular interest, especially in view of the new therapy options, since with the modern therapy methods can only improve prognosis if the diagnosis is made early.

When cardiac amyloidosis is suspected, three procedures are currently used in clinical practice

  1. myocardial biopsy (BX)
  2. cardiac MRI (CMR)
  3. scintigraphy with 99mTc phosphates as tracer (scintigraphy)

Myocardial biopsy is not suitable as a broad screening method due to cost, effort, and limited feasibility at designated centers. It's rather a goldstandard for confirming nonconclusive findings or for further differential diagnosis or prognostic assessment.

Scintigraphy and CMR are the established and regularly used methods for the detection of cardiac amyloidosis.

Scintigraphy is a cost-effective examination that can be performed on an outpatient basis with low radiation exposure and high sensitivity and specificity for the detection of cardiac (ATTR) amyloidosis, especially in (still) asymptomatic patients. Scintigraphy is already recommended for the screening of ATTR amyloidosis. Besides scintigraphy, the CMR also offers good sensitivity (80%) and specificity (94%) for the diagnosis of cardiac amyloidosis, CMR also offers the advantage of a comprehensive cardiac differential diagnosis with possible exclusion of amyloidosis. It can also be performed on an outpatient basis, does not require a radiation-based procedure and can diagnose cardiac amyloidosis with high reproducibility, both with and without contrast medium. Which of the latter two examinations is more suitable for amyloidosis screening has not been conclusively determined. Although CMR and scintigraphy are regulary used for amyloidosis screening, it is not yet known, which of the two examinations is more suitable.

The aim of the study is to estimate the prevalence of cardiac amyloidosis in mild-to-moderate AS.

Furthermore, a screening algorithm based on echocardiographic parameters should be developed, to facilitate the early detection of cardiac amyloidosis: This would allow earlier initiation of therapy and thus better therapeutic success in patients with cardiac amyloidosis. Accordingly, a better quality of life as well as a prolonged survival of these severely affected patients could be expected Furthermore, the evaluation of follow-up investigation should clarify whether patients with cardiac amyloidosis suffer a faster progression of their AS than those without amyloidosis.

A comparison of the imaging modalities (CMR and SZG) will provide clues for further delineation of the indication. of these in order to develop targeted diagnostic algorithms that are as efficient as possible.

Details
Condition aortic valve stenosis, Aortic Stenosis, Heart Valve Disease, VALVULAR HEART DISEASE, Amyloidosis, Amyloid
Treatment CMR, Scintigraphy
Clinical Study IdentifierNCT05010980
SponsorHeinrich-Heine University, Duesseldorf
Last Modified on26 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

Patients who are incapable of giving consent
Age < 65 years
patients who have not given their written consent
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note