Cardiac TransplantNCT01643564
Cytokine Profiling Post-Heart Transplant
An observational study of Cardiac Transplant, run by University of Minnesota.
Trial summary
Measurement of cytokine levels in post-cardiac transplant patients with unexplained graft dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Transplant
- Type of treatment
- Injection or infusion
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jun 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cardiology Clinic and inpatient service. Normal controls are volunteers from within the community.
Who may be able to join
- Group 1
- 18 years and older
- Cardiac Transplant recipient with graft dysfunction of unknown etiology
- Group 2
- 18 years or older
- No history of heart failure or cardiac transplantation Group 3
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- 18 years or older
- Class II-IV heart failure Group 4
- 18 years or older
- Heart Transplant 6 months or greater prior to blood draw
- No graft dysfunction
Who cannot join
- Group 1 Heart Transplant with Unexplained Graft Dysfunction
- Cellular or antibody-mediated cardiac allograft dysfunction
- Group 2 Normal Control group
- Active infection within 1 month of blood draw
- Known Inflammatory Disease
- Group 3 Heart Failure Group
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- Active infection within 1 month of blood draw
- Known Inflammatory Disease
- Group 4 Heart Transplant with Normal Graft Function Group
- Active infection within 1 month of blood draw
- Known graft dysfunction
- Known Inflammatory Disease
About this study
Official title: Cytokine Profiling of Cardiac Transplant Recipients
Measurement of cytokine levels in post-cardiac transplant patients with unexplained graft dysfunction.
- Conditions
- Cardiac Transplant
- Keywords
- Transplant, Cytokines, Graft Dysfunction
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 |
|---|---|---|
| Group 1 | Heart Transplant Recipients with Unexplained Graft Dysfunction | |
| Group 2 | Normal Control | |
| Group 3 | Class III-IV Heart Failure | |
| Group 4 | Heart Transplant Recipients with Normal Graft Function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection
Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Subject Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac TransplantStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter M Eckman, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643564
- Sponsor's protocol ID
- 1111M06547
- Status last verified
- Oct 2023
- First submitted
- 16 Jul 2012
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Profiling of Cardiac Transplant Recipients
- ClinicalTrials.gov ID
- NCT01643564
- Acronym / sponsor ID
- 1111M06547
- Conditions
- Cardiac Transplant
- Keywords
- Transplant, Cytokines, Graft Dysfunction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Subject Recruitment
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Jul 2012 (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.
Measurement of cytokine levels in post-cardiac transplant patients with unexplained graft dysfunction.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Heart Transplant Recipients with Unexplained Graft Dysfunction |
| Group 2 | – | –Normal Control |
| Group 3 | – | –Class III-IV Heart Failure |
| Group 4 | – | –Heart Transplant Recipients with Normal Graft Function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology Clinic and inpatient service. Normal controls are volunteers from within the community.
Key inclusion criteria (11 listed)
- Group 1
- 18 years and older
- Cardiac Transplant recipient with graft dysfunction of unknown etiology
- Group 2
- 18 years or older
Key exclusion criteria (12 listed)
- Group 1 Heart Transplant with Unexplained Graft Dysfunction
- Cellular or antibody-mediated cardiac allograft dysfunction
- Group 2 Normal Control group
- Active infection within 1 month of blood draw
- Known Inflammatory Disease
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
Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection
Time frame: 12 months
Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection
Results and safety
The study was stopped early (reason given: Subject Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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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.
Peter M Eckman, MD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Transplant, run by University of Minnesota.
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 11 inclusion and 12 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 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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: Subject Recruitment). 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?
Differences in cytokine profiles between stable heart transplant recipients and those with acute rejection (time frame: 12 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 4 Oct 2023.