New training program aims to catch rare heart disease earlier
NCT ID NCT07338942
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This study enrolls about 4,000 adults aged 60 and older with heart failure who are at high risk for ATTR amyloidosis, a rare disease that stiffens the heart. Doctors receive special training on how to spot and diagnose the condition using standard tests. The goal is to see if this training helps identify more cases early, so patients can get treatment sooner.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 4,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 60 years, at the time of signing the informed consent (ICF). 2. Documented diagnosis of symptomatic heart failure (NYHA class I-III) at enrolment, and current diagnosis or a medical history of HF 3. Documented Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) \> 300 pg/mL at enrolment. 4. Documented LVEF ≥40% at enrolment. 5. Documented LVH defined as end-diastolic wall thickness of ≥12 mm (IVS or PWT) on transthoracic Echocardiogram (TTE) at enrolment. 6. Patients who are willing and able to comply with all scheduled visits, laboratory tests, and other study procedures. 7. Willing and able to undergo 99mTc-PYP scintigraphy. 8. 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. Exclusion Criteria: 1. 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. 2. Known serum free light chain (sFLC), serum immunofixation electrophoresis (sIFE), or urine immunofixation electrophoresis (uIFE) anomalies. 3. Prior clinical history of Coronary Artery Bypass Grafting (CABG) or multi-vessel obstructive coronary disease (\>50% stenosis of \>2 epicardial coronary arteries). 4. Acute Myocardial Infarction (AMI) within 6 months before Screening. 5. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Beijing, 100029, China
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Research Site
Beijing, 100034, China
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Research Site
Beijing, 100037, China
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Research Site
Beijing, 100142, China
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Research Site
Beijing, 100191, China
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Research Site
Changlexi, 710032, China
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Research Site
Changsha, 410000, China
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Research Site
Changsha, 410008, China
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Research Site
Changsha, 410011, China
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Research Site
Chengdu, 610041, China
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Chengdu, 610072, China
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Research Site
Chongqing, 400016, China
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Research Site
Chongqing, 400030, China
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Research Site
Dalian, 116011, China
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Research Site
Fuzhou, 350001, China
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Research Site
Fuzhou, 350005, China
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Research Site
Guangdong Province, 510060, China
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Research Site
Guangzhou, 510100, China
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Research Site
Guangzhou, 510515, China
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Research Site
Guiyang, 550044, China
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Research Site
Hangzhou, 310009, China
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Research Site
Harbin, 150001, China
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Research Site
Hefei, 230001, China
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Research Site
Hefei, 230022, China
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Research Site
Jinan, 250012, China
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Research Site
Jinan, 250021, China
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Research Site
Nanchang, 330006, China
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Research Site
Nanjing, 210006, China
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Research Site
Nanjing, 210029, China
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Research Site
Nanning, 530000, China
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Research Site
Qingdao, 266003, China
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Research Site
Shanghai, 200032, China
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Research Site
Shanghai, 200040, China
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Research Site
Shanghai, 200080, China
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Research Site
Shanghai, China
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Research Site
Shenyang, 110001, China
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Research Site
Shijiazhuang, 050001, China
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Research Site
Shijiazhuang, 50051, China
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Research Site
Suzhou, 215006, China
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Research Site
Taiyuan, 030001, China
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Research Site
Wenzhou, 325000, China
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Research Site
Wuhan, 430030, China
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Research Site
Wuhan, 430060, China
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Research Site
Wuhan, 430071, China
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Research Site
Wuhan, CN-430022, China
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Research Site
Xi'an, 710061, China
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Research Site
Xiamen, 361003, China
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Research Site
Zhengzhou, 450000, China
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Other studies related to the condition(s) this trial covers.
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