Ventricular Dysfunction, LeftNCT02428894
Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation
An observational study of Ventricular Dysfunction, Left, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to characterize changes in the plasma proteome over time following left ventricular assist device (LVAD) implantation. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Ventricular Dysfunction, Left
- What is being tested?
- LVAD
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jan 2017
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be recruited from the University of Colorado Hospital Advanced Heart Failure Program.
Who may be able to join
- Planned HeartMate II LVAD implantation
- Planned warfarin (goal INR, 2.0-3.0) and low-dose aspirin therapy post-LVAD placement
Who cannot join
- Prior history of mechanical circulatory support;
- Body weight < 110 lbs;
- Pre-existing hemolytic, bleeding, or immunologic disorders prior to LVAD implantation;
- Severe aortic stenosis;
- Renal failure requiring dialysis;
- Hepatic dysfunction resulting in severe coagulopathies;
Show all 14Show fewer
- Recent serious infection;
- Current need for prolonged ventilatory support;
- Prior organ transplantation;
- Blood transfusion within 14 days of the first planned study blood draw;
- Concomitant immunosuppressant or chemotherapeutic agents;
- Pregnant women;
- Decisionally challenged or prisoners;
- Unwilling to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
The purpose of this study is to characterize changes in the plasma proteome over time following left ventricular assist device (LVAD) implantation.
- Conditions
- Ventricular Dysfunction, Left
- Being tested
- LVAD
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVADDevice
Also called HeartMate II
| Study group | Role | What they receive |
|---|---|---|
| LVAD recipients | Not described Receives: Device: LVAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative differences in plasma protein abundance
Measured: Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Dysfunction, LeftStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Aquilante, Pharm.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428894
- Sponsor's protocol ID
- 14-1376
- Other IDs
- 14GRNT20380495
- Status last verified
- Jul 2017
- First submitted
- 17 Apr 2015
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation
- ClinicalTrials.gov ID
- NCT02428894
- Acronym / sponsor ID
- 14-1376
- Conditions
- Ventricular Dysfunction, Left
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 Apr 2015 (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.
The purpose of this study is to characterize changes in the plasma proteome over time following left ventricular assist device (LVAD) implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LVAD recipients | – | Device: LVAD |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from the University of Colorado Hospital Advanced Heart Failure Program.
Key inclusion criteria (2 listed)
- Planned HeartMate II LVAD implantation
- Planned warfarin (goal INR, 2.0-3.0) and low-dose aspirin therapy post-LVAD placement
Key exclusion criteria (14 listed)
- Prior history of mechanical circulatory support;
- Body weight < 110 lbs;
- Pre-existing hemolytic, bleeding, or immunologic disorders prior to LVAD implantation;
- Severe aortic stenosis;
- Renal failure requiring dialysis;
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 |
|---|---|---|
| LVADAlso: HeartMate II | Device | LVAD recipients |
Primary outcome
Quantitative differences in plasma protein abundance
Time frame: Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation
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 17 Jul 2017.
Related trials for Ventricular Dysfunction, Left
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
Cardiovascular Diseases, Heart Diseases
RecruitingObservational study
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
Ventricular Dysfunction, Right
Active, not recruitingObservational study
The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome
Tako Tsubo Cardiomyopathy, Microvascular Dysfunction
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
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.
Christina Aquilante, Pharm.D. principal investigator
University of Colorado, Denver
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 Ventricular Dysfunction, Left, run by University of Colorado, Denver 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 2 inclusion and 14 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 17 Jul 2017. 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?
Quantitative differences in plasma protein abundance (time frame: Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation). 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 17 Jul 2017.