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New treatment option for ATTR-CM
Official title Implementation of Standardized Early Identification and Diagnosis for Transthyretin Amyloidosis (ATTR) in High-Risk Populations
ClinicalTrials.gov ID: NCT07338942
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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.
You likely can't join if
- Known etiology of myocardial disease: A confirmed diagnosis of amyloidosis (e.g., amyloid A amyloidosis, primary [light chain] amyloidosis), a...
- 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...
- 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...
See the full eligibility criteria
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changlexi, China
- Changsha, China
- Chengdu, China
- Chongqing, China
- Dalian, China
- Fuzhou, China
- Guangdong Province, China
- Guangzhou, China
- Guiyang, China
- Hangzhou, China
- Harbin, China
- Hefei, China
- Jinan, China
- Nanchang, China
- Nanjing, China
- Nanning, China
- Qingdao, China
- Shanghai, China
- Shenyang, China
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Changlexi, China; Changsha, China; Chengdu, China; Chongqing, China; Dalian, China and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.