To Measure Galectin-3 in Heart Failure Patients on Commercial PlatformsNCT01980862
Blood Collection From Heart Failure Patients to Evaluate for Galectin-3 Measurement Differences Using Various Collection Tubes
An observational study of To Measure Galectin-3 in Heart Failure Patients on Commercial Platforms, run by Fujirebio Diagnostics, Inc. at 1 site in United States.
Trial summary
Single-site blood collection investigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Measure Galectin-3 in Heart Failure Patients on Commercial Platforms
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2013
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 45 matched door serum and plasma. Samples set collected form individual Heart Failure patients for galecin-3 measurements
Who may be able to join
- Heart Failure patients New York Heart Association class able to provide (4) collection tube types Subjects > 18 years old All subjects must provide informed consent and associated documentation
Who cannot join
- Subjects that cannot tolerate blood withdrawal of 4 specimens collection tube tubes (approximately 40 mLs)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine
Baltimore, Maryland, 21201
About this study
Single-site blood collection investigation.
Read the detailed description
45 Heart Failure patients will be recruited. Patients will provide a one-time blood sample specimen collection. Theses samples will be de-identified and provided for measurement of Galectin-3 on commercial platforms.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure patients | No interventions for this study. Blood draw provided by patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain 45 matched donor serum and plasma samples sets collected from Heart Failure patients for galectin-3 measurements
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Measure Galectin-3 in Heart Failure Patients on Commercial PlatformsStudies 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
- 48 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fujirebio Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Christenson, MD, Principal investigator, Universtiy of Maryland School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980862
- Sponsor's protocol ID
- FDI-83
- Status last verified
- Aug 2014
- First submitted
- 5 Nov 2013
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Collection From Heart Failure Patients to Evaluate for Galectin-3 Measurement Differences Using Various Collection Tubes
- ClinicalTrials.gov ID
- NCT01980862
- Acronym / sponsor ID
- FDI-83
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fujirebio Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 Nov 2013 (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.
Single-site blood collection investigation.
Detailed description
45 Heart Failure patients will be recruited. Patients will provide a one-time blood sample specimen collection. Theses samples will be de-identified and provided for measurement of Galectin-3 on commercial platforms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure patients | – | –No interventions for this study. Blood draw provided by patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 45 matched door serum and plasma. Samples set collected form individual Heart Failure patients for galecin-3 measurements
Key inclusion criteria (1 listed)
- Heart Failure patients New York Heart Association class able to provide (4) collection tube types Subjects > 18 years old All subjects must provide informed consent and associated documentation
Key exclusion criteria (1 listed)
- Subjects that cannot tolerate blood withdrawal of 4 specimens collection tube tubes (approximately 40 mLs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Obtain 45 matched donor serum and plasma samples sets collected from Heart Failure patients for galectin-3 measurements
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
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.
Robert Christenson, MD principal investigator
Universtiy of Maryland School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Measure Galectin-3 in Heart Failure Patients on Commercial Platforms, run by Fujirebio Diagnostics, Inc. at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Obtain 45 matched donor serum and plasma samples sets collected from Heart Failure patients for galectin-3 measurements (time frame: 6 months). 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 5 Aug 2014.