Natriuretic Peptides for Low Volume Platforms Enrollment Study Protocol
Study on Heart Substances for Heart Failure Diagnosis
Nicholas Harrison
Primary Investigator
Brief description of study
The purpose of this study protocol is to collect blood samples and relevant medical data from the intended use population presenting with a clinical suspicion of acute heart failure (i.e. new-onset heart failure or worsening symptoms suggestive of decompensated or exacerbated heart failure). Blood samples are collected to support assay verification and the assay’s regulatory approval of natriuretic peptide assays on low volume platforms. The objective of this study is to collect blood samples and
These samples will be tested to verify method comparison for each of the IUO natriuretic peptide assays (Access NT-proBNP Assay (P/N C71977) and Access BNP II Assay (P/N D24688)) between Access 2, DxC 500i and the predicate device DxI 9000 Access Immunoanalyzer under separate protocols.
Detailed description of study
Approximately twenty (20) mL of blood total will be collected per subject: 10 mL in Dipotassium Ethylenediaminetetraacetic Acid (K2 EDTA) tubes and 10 mL of blood in Lithium Heparin tubes while adhering to sample handling requirements.
Samples are to be handled in accordance with handling requirements and laboratory standards. Place blood collection tubes in a cooler with frozen gel packs immediately following blood draw, or in 2 – 8 °C refrigerator (if time allows before processing), and place processed aliquots in the freezer within one hour of collection at -70 °C (or colder). Enrollment sites shall not have access and are blinded to the study testing results performed as part of a separate testing protocol.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Acute Heart Failure
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Age: 22 years - 100 years
-
Gender: All
Inclusion criteria
- Ability to provide informed consent
- Adult 22 years old, of any sex, race, ethnicity
- Presenting with a clinical suspicion of acute heart failure (i.e.
new-onset heart failure or worsening symptoms suggestive of
decompensated or exacerbated heart failure). - Ability to fulfill study data collection requirements
Exclusion Criteria
- Dyspnea clearly not secondary to heart failure (e.g., primary
lung disease or chest trauma). - On dialysis
- Subject clinical/medical history access is not available to the
Sponsor, delegates, and FDA or other regulatory agencies upon
request. - Active participation in a clinical study that may interfere with
participation in this study (e.g., investigational drug study).
Previous enrollment under this study protocol. - Reason(s) determined by the Principal Investigator that would
place the individual at increased risk or preclude the individual
from fully complying with or completing the study
This study investigates the use of natriuretic peptides to diagnose acute heart failure. Acute heart failure is when the heart suddenly can't pump enough blood to meet the body's needs. This can happen when heart failure starts suddenly or when existing heart problems get worse. Blood samples from people suspected of having acute heart failure will be collected to help check the accuracy of tests that measure natriuretic peptides, which are substances made by the heart.
Participants will have about 20 mL of blood taken, split between two types of tubes. These samples will be handled carefully, kept cool, and frozen for later testing. The blood tests will be done to compare different machines used to measure natriuretic peptides, but the results will not be shared with the participants or the sites where they enroll.
- Who can participate: Adults aged 22 years or older with suspected acute heart failure can participate. They must be able to give consent and meet data collection requirements. People with non-heart-related breathing issues or on dialysis are not eligible.
- Study details: Participants will have blood drawn and samples will be handled according to strict guidelines. The study involves collecting blood samples for testing without participants knowing the results. There is no medication or placebo involved.
