ATTR-CMNCT07338942
Implementation of Standardized Early Identification and Diagnosis for Transthyretin Amyloidosis (ATTR) in High-Risk Populations
A study testing implementation of standard early identification and diagnosis of ATTR in people with ATTR-CM, run by AstraZeneca at 48 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- ATTR-CM
- What is being tested?
- implementation of standard early identification and diagnosis of ATTR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 48 sitesChina
- Study dates
- 21 Apr 2026to 20 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years, at the time of signing the informed consent (ICF).
- Documented diagnosis of symptomatic heart failure (NYHA class I-III) at enrolment, and current diagnosis or a medical history of HF
- Documented Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 300 pg/mL at enrolment.
- Documented LVEF ≥40% at enrolment.
- Documented LVH defined as end-diastolic wall thickness of ≥12 mm (IVS or PWT) on transthoracic Echocardiogram (TTE) at enrolment.
- Patients who are willing and able to comply with all scheduled visits, laboratory tests, and other study procedures.
- Willing and able to undergo 99mTc-PYP scintigraphy.
- Capable of giving signed ICF as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- Known etiology of myocardial disease: A confirmed diagnosis of amyloidosis (e.g., amyloid A amyloidosis, primary [light chain] amyloidosis), a non-amyloid infiltrative cardiomyopathy (i.e., cardiac sarcoidosis, hemochromatosis), muscular dystrophies, cardiomyopathy with reversible causes, hypertensive heart disease, pheochromocytoma, hypertrophic obstructive cardiomyopathy with known geneticetiology, or known pericardial constriction, etc. These diagnoses of myocardial disease could be further validated by the Investigator at Screening if the prior diagnosis is considered suspect.
- Known serum free light chain (sFLC), serum immunofixation electrophoresis (sIFE), or urine immunofixation electrophoresis (uIFE) anomalies.
- Prior clinical history of Coronary Artery Bypass Grafting (CABG) or multi-vessel obstructive coronary disease (>50% stenosis of >2 epicardial coronary arteries).
- Acute Myocardial Infarction (AMI) within 6 months before Screening.
- Unable to undergo 99mTc-PYP examination, such as:
- 1)Previously documented hypersensitivity reaction to 99mTc; 2)Severe renal insufficiency (eGFR <30 mL/min/1.73m²); 3)Severe myelosuppression (leukocytes <3.5×10⁹/L or platelets <80×10⁹/L). 6.Other medical or psychiatric condition including recent (within the past year) active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the patient inappropriate for the study.
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
China48 sites
Research Site
Beijing, 100029
Research Site
Beijing, 100034
Research Site
Beijing, 100037
Research Site
Beijing, 100142
Research Site
Beijing, 100191
Research Site
Changlexi, 710032
Research Site
Changsha, 410000
Research Site
Changsha, 410008
Research Site
Changsha, 410011
Research Site
Chengdu, 610041
Research Site
Chengdu, 610072
Research Site
Chongqing, 400016
Research Site
Chongqing, 400030
Research Site
Dalian, 116011
Research Site
Fuzhou, 350001
Research Site
Fuzhou, 350005
Research Site
Guangdong Province, 510060
Research Site
Guangzhou, 510100
Research Site
Guangzhou, 510515
Research Site
Guiyang, 550044
Research Site
Hangzhou, 310009
Research Site
Harbin, 150001
Research Site
Hefei, 230001
Research Site
Hefei, 230022
Research Site
Jinan, 250012
Research Site
Jinan, 250021
Research Site
Nanchang, 330006
Research Site
Nanjing, 210006
Research Site
Nanjing, 210029
Research Site
Nanning, 530000
Research Site
Qingdao, 266003
Research Site
Shanghai, 200032
Research Site
Shanghai, 200040
Research Site
Shanghai, 200080
Research Site
Shanghai
Research Site
Shenyang, 110001
Research Site
Shijiazhuang, 050001
Research Site
Shijiazhuang, 50051
Research Site
Suzhou, 215006
Research Site
Taiyuan, 030001
Research Site
Wenzhou, 325000
Research Site
Wuhan, 430030
Research Site
Wuhan, 430060
Research Site
Wuhan, 430071
Research Site
Wuhan, CN-430022
Research Site
Xi'an, 710061
Research Site
Xiamen, 361003
Research Site
Zhengzhou, 450000
About this study
Official title: A Prospective, Multicenter, Intervention Study to Evaluate the Impact of the Implementation of Standardized Transthyretin Amyloidosis (ATTR) Early Identification and Diagnosis in ATTR High Risk Population
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.
- Conditions
- ATTR-CM
- Being tested
- implementation of standard early identification and diagnosis of ATTR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation of standard early identification and diagnosis of ATTRBehavioural
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 group | Role | What they receive |
|---|---|---|
| one arm without control group | Other | 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. Receives: Behavioral: implementation of standard early identification and diagnosis of ATTR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients diagnosed with ATTR in high-risk population.
Measured: Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start21 Apr 2026
- Primary completion20 Nov 2027 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ATTR-CMStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338942
- Sponsor's protocol ID
- D8455L00002
- Status last verified
- Aug 2026
- First submitted
- 3 Dec 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Intervention Study to Evaluate the Impact of the Implementation of Standardized Transthyretin Amyloidosis (ATTR) Early Identification and Diagnosis in ATTR High Risk Population
- ClinicalTrials.gov ID
- NCT07338942
- Acronym / sponsor ID
- D8455L00002
- Conditions
- ATTR-CM
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 20 Nov 2027 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm without control group | Other | Behavioral: implementation of standard early identification and diagnosis of ATTRThis 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 60 years, at the time of signing the informed consent (ICF).
- Documented diagnosis of symptomatic heart failure (NYHA class I-III) at enrolment, and current diagnosis or a medical history of HF
- Documented Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 300 pg/mL at enrolment.
- Documented LVEF ≥40% at enrolment.
- Documented LVH defined as end-diastolic wall thickness of ≥12 mm (IVS or PWT) on transthoracic Echocardiogram (TTE) at enrolment.
Key exclusion criteria (6 listed)
- Known etiology of myocardial disease: A confirmed diagnosis of amyloidosis (e.g., amyloid A amyloidosis, primary [light chain] amyloidosis), a non-amyloid infiltrative cardiomyopathy (i.e., cardiac sarcoidosis, hemochromatosis), muscular dystrophies, cardiomyopathy with reversible causes, hypertensive heart disease, pheochromocytoma, hypertrophic obstructive cardiomyopathy with known geneticetiology, or known pericardial constriction, etc. These diagnoses of myocardial disease could be further validated by the Investigator at Screening if the prior diagnosis is considered suspect.
- Known serum free light chain (sFLC), serum immunofixation electrophoresis (sIFE), or urine immunofixation electrophoresis (uIFE) anomalies.
- Prior clinical history of Coronary Artery Bypass Grafting (CABG) or multi-vessel obstructive coronary disease (>50% stenosis of >2 epicardial coronary arteries).
- Acute Myocardial Infarction (AMI) within 6 months before Screening.
- Unable to undergo 99mTc-PYP examination, such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implementation of standard early identification and diagnosis of ATTRThe 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. | Behavioural | one arm without control group |
Primary outcome
Proportion of patients diagnosed with ATTR in high-risk population.
Time frame: Week 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
Related trials for ATTR-CM
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruitingPhase 3
EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
Transthyretin Amyloid Cardiomyopathy
RecruitingPhase 3
MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Active, not recruitingPhase 3
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Not yet recruitingObservational study
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implementation of standard early identification and diagnosis of ATTR in people with ATTR-CM, run by AstraZeneca at 48 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients diagnosed with ATTR in high-risk population. (time frame: Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.