Status
Not yet recruiting
Phase
Not applicable
Enrollment
120
Locations
0
Results
Not posted
Publications
0
Study summary
To validate the NTproBNP2 Test Kit by using the test results of the predicate device as a reference. It will be demonstrated that the investigational product (NTproBNP2 Test Kit) and the predicate are equivalent. Subsequently, it will be demonstrated that the investigational product can be used in clinical testing.
Interventions
No intervention details reported.
Timeline
First posted
Oct 6, 2025
Study start
Oct 2025
Primary completion
Oct 2025
Study completion
Jan 2026
Results posted
Not reported
Registry updated
Oct 6, 2025
Outcomes
AQT90 FLEX NTproBNP2 Test Kit - Clinical Evaluation - China
Time frame · 12 months
Clinical evaluation indicator: The correlation coefficient between the investigational reagent and the predicate. Evaluation criteria: The correlation coefficient between the investigational reagent and the predicate shall not be less than 0.95. The slope should be within the range of \[0.9, 1.1\]. If this requirement is not met, it is recommended to increase the sample size and provide a detailed rationale.
Not reported in the indexed record.
Eligibility
Inclusion Criteria: Samples that meet all the following criteria will be eligible for enrollment: 1. Samples from subjects with current or previous signs and/or symptoms of heart failure, or diagnosed heart failure. 2. Sample-related information is available, including a unique and traceable number, sample type, age, gender, date of sample collection, and clinical diagnosis, etc.. 3. The sample volume is adequate, no less than 2 mL of whole blood. 4. The sample collection shall meet the informed consent waiver requirements of the ethics committee. Exclusion Criteria: Samples that meet any of the following criteria will be excluded: 1. Duplicate collection of samples from the same subject. 2. Samples that do not meet the collection, handling, and storage requirements outlined in the product's instructions for use. 3. Samples that are suspected of being poor quality, i.e. samples suspected of containing clots, visible hemolysis or lipids, or samples suspected of being contaminated with possible interfering substances.
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Universidade do Porto · Heart Failure
Not applicable
Recruiting
160
2026-07
Boston Medical Center · Congestive Heart Failure · Volume Overload
Not applicable
Not yet recruiting
200
2026-06
Norfolk and Norwich University Hospitals NHS Foundation Trust · Vascular Surgical Procedure
Not applicable
Recruiting
200
2026-06
China National Center for Cardiovascular Diseases · AKI - Acute Kidney Injury · Cardiac Surgical Procedures
Phase 4
Not yet recruiting
694
2026-06
Cambridge University Hospitals NHS Foundation Trust · Heart Failure
Not applicable
Recruiting
250
2026-05
Chulalongkorn University · Acute Kidney Failure Stage 3
Not applicable
Completed
100
2026-05
Ottawa Heart Institute Research Corporation · Chronic Right-Sided Heart Failure · Pulmonary Arterial Hypertension
Phase 4
Completed
15
2026-05
Novartis · Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)
Not applicable
Completed
236
2026-04
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.