Congestive Heart FailureNCT02107495
Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting
An observational study of Congestive Heart Failure, run by Samsung Electronics at 3 sites in United States.
Trial summary
To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Samsung LABGEO IVD-A20 CHF Test
- Type of treatment
- Medical device
- How many people
- 191 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects to be recruited for this study will be presenting to one of five point of care sites located in the USA. The sites will be emergency room or POL sites, and will include primary care facilities representative of those typically serving the intended use population for the test.
Who may be able to join
- CHF Subjects: 21 years of age or greater, with clinically confirmed CHF or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure.
- Subjects with Potentially confounding comorbidities: Non-CHF subjects 21 years of age or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD)
- Healthy Subjects: apparently healthy subjects greater than 45 years of age, with no prior history of cardiac-related disease.
Who cannot join
- Apparently healthy subjects with a history of MI, CHF or other cardiac-related disease;
- Subjects with acute decompensated heart failure currently on nesiritide therapy;
- Subjects having participated in another experimental drug, biologic, or invasive device study within 30 days prior to signing informed consent for this study, or enrolled concurrently in any other investigative study; and
- Subjects unable to or refusing to provide written informed consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland
Baltimore, Maryland, 21201
Manassas Clinical Research Center
Manassas, Virginia, 20110
Minneapolis Medical Research Foundation
Minneapolis, Minnesota, 55404
About this study
To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay.
- Conditions
- Congestive Heart Failure
- Being tested
- Samsung LABGEO IVD-A20 CHF Test
- Keywords
- CHF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samsung LABGEO IVD-A20 CHF TestDevice
Also called LABGEO IVD-A20 CHF Test, A20 CHF Test,
| Study group | Role | What they receive |
|---|---|---|
| CHF-confirmed subjects | Subjects 21 years of age or greater with clinically confirmed heart failure or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure. Receives: Device: Samsung LABGEO IVD-A20 CHF Test | |
| Subjects with potentially co-morbidities | non-CHF subjects 21 years or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD). Receives: Device: Samsung LABGEO IVD-A20 CHF Test | |
| Apparently healthy subjects | Apparently healthy subjects (meeting inclusion criteria) greater than 45 years of age, with no prior history of myocardial infarction (MI), acute coronary syndrome (ACS) congestive heart failure (CHF) or any other cardiac-related disease. Receives: Device: Samsung LABGEO IVD-A20 CHF Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of clinically-confirmed CHF subjects for whom the Samsung LABGEO IVD-A20 CHF Test result was positive (clinical sensitivity).
Measured: baseline
The proportion of non-CHF subjects for whom the LABGEO IVD A20 CHF Test result was negative (clinical specificity).
Measured: baseline
Using a Passing-Bablok regression analysis, estimates of intercept and slope will be computed. Estimates of bias and corresponding 95% confidence interval for true bias at clinical decision threshold of 125mg/mL and 450 pg/mL will also be computed.
Method comparison will be assessed using a Passing-Bablok regression analysis to determine the relationship between the Samsung LABGEO IVD-A20 CHF Test measurement in plasma and the corresponding measurement in plasma obtained from the comparator assay.
Measured: baseline
Secondary outcomes (6)
The proportion of subjects with a positive LABGEO IVD-A20 CHF Test result, for whom a clinical diagnosis of CHF was confirmed (positive predictive value).
Measured: baseline
The proportion of subjects with a negative LABGEO IVD-A20 CHF Test result, for whom a clinical diagnosis of CHF was confirmed (negative predictive value).
Measured: baseline
Computation of Receiver Operating Characteristic (ROC) curve and area under the curve (AUC) with 95% confidence interval for the true AUC.
This analysis will assess the ability of the Samsung LABGEO IVD-A20 CHF Test to discriminate between confirmed CHF subjects and non-CHF subjects.
Measured: baseline
Variance components analysis will be conducted on data collected from each whole blood specimen undergoing point-of-care precision testing at study site. Estimates of within-run, between run, between day and total precision will be computed.
The Samsung LABGEO IVD-A20 CHF Test result will be modeled as a function of testing days and runs, with replicates fully nested within runs, and runs fully nested within days.
Measured: 10 days
Variance components analysis will be conducted on data collected from each plasma specimen undergoing point-of-care precision testing at study site. Estimates of within-run, between run, between day and total precision will be computed.
The Samsung LABGEO IVD-A20 CHF Test result will be modeled as a function of testing days and runs, with replicates fully nested within runs, and runs fully nested within days.
Measured: 20 days
Mixed model regression analysis will be conducted on each specimen type (whole blood vs. plasma) and storage condition.
The natural logarithm of the Samsung LABGEO IVD-A20 CHF Test measurement will be modeled as a linear function of time (in hours) after baseline testing.A separate linear function will be fitted to data collected from each study specimen and the intercepts and slops from individual specimens will be modeled as random effects.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Optimize calibration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Electronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nexus DX
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107495
- Sponsor's protocol ID
- A20-01
- Status last verified
- Feb 2015
- First submitted
- 3 Apr 2014
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting
- ClinicalTrials.gov ID
- NCT02107495
- Acronym / sponsor ID
- A20-01
- Conditions
- Congestive Heart Failure
- Keywords
- CHF
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Optimize calibration
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Samsung ElectronicsIndustry (pharma, biotech, devices)
- Collaborators
- Nexus DX
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHF-confirmed subjects | – | Device: Samsung LABGEO IVD-A20 CHF TestSubjects 21 years of age or greater with clinically confirmed heart failure or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure. |
| Subjects with potentially co-morbidities | – | Device: Samsung LABGEO IVD-A20 CHF Testnon-CHF subjects 21 years or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD). |
| Apparently healthy subjects | – | Device: Samsung LABGEO IVD-A20 CHF TestApparently healthy subjects (meeting inclusion criteria) greater than 45 years of age, with no prior history of myocardial infarction (MI), acute coronary syndrome (ACS) congestive heart failure (CHF) or any other cardiac-related disease. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects to be recruited for this study will be presenting to one of five point of care sites located in the USA. The sites will be emergency room or POL sites, and will include primary care facilities representative of those typically serving the intended use population for the test.
Key inclusion criteria (3 listed)
- CHF Subjects: 21 years of age or greater, with clinically confirmed CHF or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure.
- Subjects with Potentially confounding comorbidities: Non-CHF subjects 21 years of age or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD)
- Healthy Subjects: apparently healthy subjects greater than 45 years of age, with no prior history of cardiac-related disease.
Key exclusion criteria (4 listed)
- Apparently healthy subjects with a history of MI, CHF or other cardiac-related disease;
- Subjects with acute decompensated heart failure currently on nesiritide therapy;
- Subjects having participated in another experimental drug, biologic, or invasive device study within 30 days prior to signing informed consent for this study, or enrolled concurrently in any other investigative study; and
- Subjects unable to or refusing to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Samsung LABGEO IVD-A20 CHF TestAlso: LABGEO IVD-A20 CHF Test, A20 CHF Test, | Device | Apparently healthy subjects, CHF-confirmed subjects, Subjects with potentially co-morbidities |
Primary outcome
The proportion of clinically-confirmed CHF subjects for whom the Samsung LABGEO IVD-A20 CHF Test result was positive (clinical sensitivity).
Time frame: baseline
The proportion of non-CHF subjects for whom the LABGEO IVD A20 CHF Test result was negative (clinical specificity).
Time frame: baseline
Using a Passing-Bablok regression analysis, estimates of intercept and slope will be computed. Estimates of bias and corresponding 95% confidence interval for true bias at clinical decision threshold of 125mg/mL and 450 pg/mL will also be computed.
Time frame: baseline
Method comparison will be assessed using a Passing-Bablok regression analysis to determine the relationship between the Samsung LABGEO IVD-A20 CHF Test measurement in plasma and the corresponding measurement in plasma obtained from the comparator assay.
6 secondary outcomes
The proportion of subjects with a positive LABGEO IVD-A20 CHF Test result, for whom a clinical diagnosis of CHF was confirmed (positive predictive value).
Time frame: baseline
The proportion of subjects with a negative LABGEO IVD-A20 CHF Test result, for whom a clinical diagnosis of CHF was confirmed (negative predictive value).
Time frame: baseline
Computation of Receiver Operating Characteristic (ROC) curve and area under the curve (AUC) with 95% confidence interval for the true AUC.
Time frame: baseline
Variance components analysis will be conducted on data collected from each whole blood specimen undergoing point-of-care precision testing at study site. Estimates of within-run, between run, between day and total precision will be computed.
Time frame: 10 days
Variance components analysis will be conducted on data collected from each plasma specimen undergoing point-of-care precision testing at study site. Estimates of within-run, between run, between day and total precision will be computed.
Time frame: 20 days
Mixed model regression analysis will be conducted on each specimen type (whole blood vs. plasma) and storage condition.
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: Optimize calibration). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Samsung Electronics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Optimize calibration). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of clinically-confirmed CHF subjects for whom the Samsung LABGEO IVD-A20 CHF Test result was positive (clinical sensitivity). (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.