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

Sponsor
AstraZeneca
Study ID
NCT07338942
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • implementation of standard early identification and diagnosis of ATTR — BEHAVIORAL
    The intervention methods include standardized ATTR early identification and diagnosis protocol, as well as quality audit. The standardized ATTR early identification and diagnosis protocol involves knowledge training, operation training and verification.

Study Details

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.

Key Dates

Start date
Apr 21, 2026
Status verified
May 2026
Primary completion
Nov 20, 2027
Completion
Nov 20, 2027

Study Design

Enrollment
4,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Other: one arm without control group
    This is a multi-center, prospective, single-arm interventional study to evaluate the impact of the implementation of standardized ATTR early identification and diagnosis in ATTR high risk population. This study will enroll approximately 4,000 adult Chinese patients at high risk for ATTR from around 50 sites in China.

Primary Outcome Measure

Proportion of patients diagnosed with ATTR in high-risk population. [ Time Frame: Week 14 ]

Central Contacts

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