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New training program aims to catch rare heart disease earlier

NCT ID NCT07338942

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 4,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

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

60 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Research Site

    Beijing, 100029, China

  • Research Site

    Beijing, 100034, China

  • Research Site

    Beijing, 100037, China

  • Research Site

    Beijing, 100142, China

  • Research Site

    Beijing, 100191, China

  • Research Site

    Changlexi, 710032, China

  • Research Site

    Changsha, 410000, China

  • Research Site

    Changsha, 410008, China

  • Research Site

    Changsha, 410011, China

  • Research Site

    Chengdu, 610041, China

  • Research Site

    Chengdu, 610072, China

  • Research Site

    Chongqing, 400016, China

  • Research Site

    Chongqing, 400030, China

  • Research Site

    Dalian, 116011, China

  • Research Site

    Fuzhou, 350001, China

  • Research Site

    Fuzhou, 350005, China

  • Research Site

    Guangdong Province, 510060, China

  • Research Site

    Guangzhou, 510100, China

  • Research Site

    Guangzhou, 510515, China

  • Research Site

    Guiyang, 550044, China

  • Research Site

    Hangzhou, 310009, China

  • Research Site

    Harbin, 150001, China

  • Research Site

    Hefei, 230001, China

  • Research Site

    Hefei, 230022, China

  • Research Site

    Jinan, 250012, China

  • Research Site

    Jinan, 250021, China

  • Research Site

    Nanchang, 330006, China

  • Research Site

    Nanjing, 210006, China

  • Research Site

    Nanjing, 210029, China

  • Research Site

    Nanning, 530000, China

  • Research Site

    Qingdao, 266003, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shanghai, 200040, China

  • Research Site

    Shanghai, 200080, China

  • Research Site

    Shanghai, China

  • Research Site

    Shenyang, 110001, China

  • Research Site

    Shijiazhuang, 050001, China

  • Research Site

    Shijiazhuang, 50051, China

  • Research Site

    Suzhou, 215006, China

  • Research Site

    Taiyuan, 030001, China

  • Research Site

    Wenzhou, 325000, China

  • Research Site

    Wuhan, 430030, China

  • Research Site

    Wuhan, 430060, China

  • Research Site

    Wuhan, 430071, China

  • Research Site

    Wuhan, CN-430022, China

  • Research Site

    Xi'an, 710061, China

  • Research Site

    Xiamen, 361003, China

  • Research Site

    Zhengzhou, 450000, China

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