Screening Algorithm for Early Detection of Occult Cardiac Amyloidosis

Early diagnosis of cardiac amyloidosis (CA) is crucial because of the poor overall survival, high mortality and the need for early therapy including new treatment possibilities for transthyretin amyloidosis. Previously considered a rare condition, CA is being demonstrated to account for up to 17 % of heart failure with preserved ejection fraction cases as well as up to 16 % of Patients with severe aortic stenosis, undergoing surgical of transcatheter aortic valve replacement. It seems that CA is being underdiagnosed as the data of post-mortem studies demonstrate that at least 25% of elderly individuals have histologic evidence of amyloid deposits. Other common conditions with increased afterload such as hypertensive or hypertrophic heart disease that mimic echocardiographic features or clinical symptoms may be the reason of postponed recognition of CA. Furthermore, the lack of definitive biomarkers makes the diagnosis even more challenging. However, it has been shown that some clinical, laboratory and echocardiographic findings, so called "red flags", may indicate occult CA. A deeper and constructive analysis of the findings and establishment of prediction criteria could possibly lead to improvement of early CA recognition and survival in subjects at risk. We aim to prospectively perform a systematic screening for CA in individuals at risk based on predefined selection criteria. Our aim is to evaluate if specific criteria would lead to increased detection of CA and in this case, to define major and minor diagnostic criteria.

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Key information

Conditions

Cardiac Amyloidosis Amyloid Neuropathies Amyloid Neuropathies, Familial Amyloidosis Amyloidosis, Familial Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Valve Diseases Heredodegenerative Disorders, Nervous System Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Proteostasis Deficiencies Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Essen

Essen, North Rhine-Westphalia, 45122, Germany

About this study

The study aims to perform a prospective screening and detect occult CA in subjects at risk with aortic valve stenosis, undergoing either transcatheter or surgical aortic valve replacement. The study has two main objectives. Firstly, we aim to determine the real prevalence of CA according to the targeted "red flags" analysis and secondly, we aim to establish an algorithm for early detection of CA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Fulfillment of following four criteria: 1) Severe aortic stenosis. 2) Age > 65 years for male and >70 years for female. 3) Increased left ventricular wall thickness ≥14 mm. 4) Blood pressure ≤ 140/90 mmHg and at least 1 major or ≥ 2 minor criteria.

Major criteria:

Carpal tunnel syndrom
Non-traumatic rupture of the biceps tendon
NT-proBNP > 1000 pg/ml
hs Troponin value above the 99th percentile without dynamic changes (≤ 20%)

Minor criteria:

Diastolic dysfunction (at least grade 2, E' < 10 cm/s)
Sinus bradycardia/AV block/pacemaker
Atrial fibrillation

Exclusion criteria

Known cardiac amyloidosis (ATTR or AL)
Unable to provide written informed consent
Refusal to provide written informed consent
Contraindications for study investigations

Treatment and study plan

Primary outcomes

Diagnosis of occult cardiac amyloidosis

Time frame: 3 years

Early diagnosis of occult cardiac amyloidosis, based on a proposed screening algorithm

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

Evaluation of a Screening Algorithm for Early Detection of Occult Cardiac Amyloidosis in Subjects at Risk

Acronym: EARLY-CA

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Jan 23, 2023
Registry last updated: Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed