NCT07338942

Implementation of Standardized Early Identification and Diagnosis for Transthyretin Amyloidosis (ATTR) in High-Risk Populations

Not yet recruiting NA Last updated 14 April 2026

What this trial tests

NA trial testing implementation of standard early identification and diagnosis of ATTR in ATTR-CM in 4,000 participants. Not yet recruiting.

Timeline

30 April 2026

Primary endpoint
20 November 2027

20 November 2027

Quick facts

Lead sponsor	AstraZeneca
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	4,000
Start date	30 April 2026
Primary completion	20 November 2027
Estimated completion	20 November 2027
Sites	1 location across China

Drugs / interventions tested

• implementation of standard early identification and diagnosis of ATTR

Conditions studied

• ATTR-CM — all drugs for ATTR-CM →

Sponsor

AstraZeneca — full company profile →

Who can join

60 and older, any sex, with ATTR-CM. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This multicenter, prospective, single-arm, interventional study will enroll about 4,000 adult patients at high risk of ATTR amyloidosis from around 50 sites in China. Eligible patients are aged ≥60 years and have documented symptomatic heart failure with left ventricular ejection fraction ≥40% and LVH. Exclusion criteria include known etiologies of myocardial diseases, anomalies of serum free light chain or serum immunofixation electrophoresis, acute myocardial infarction within 6 months before screening, and inability to undergo 99mTc-PYP. Patients will undergo a 14-week diagnostic process.

The study intervention involves knowledge training, operation training and post-training verification among investigators. Knowledge training for CV department investigators will cover disease-specific knowledge, standard diagnostic pathways, and genetics; training for investigators in echocardiology (ECHO) and nuclear medicine departments will focus on disease knowledge, standardized operating procedures (SOPs), and imaging parameter reporting. Operation training includes hands-on training in SOPs and image interpretation for ECHO and nuclear medicine investigators. Post-training verification will assess site-level compliance. Extra training will be arranged if quality audit is off target.

The primary endpoint is the proportion of patients diagnosed with ATTR amyloidosis in high-risk populations. Secondary endpoints include the proportion of patients with ATTRwt amyloidosis, concordance between local investigators and central reviewers in ECHO and 99mTc-PYP readings, and genotype distribution. All analyses will be descriptive with no pre-planned hypotheses. Risk factors associated with 99mTc-PYP-diagnosed ATTR amyloidosis will be analyzed via logistic regression models.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.