Heart FailureNCT05637242
Ventricular Assist Device (VAD) Research Registry and Blood Sub-Study
An observational study of Heart Failure, run by Corewell Health West at 1 site in United States.
Trial summary
This study is meant to predict the outcome of VAD therapy, by forming a VAD registry for quality assessment, research, and real-time monitoring of patients on VAD therapy. The goal is to optimize the use of VAD therapy for patients, to create an online quality measurement tool for VAD treatment, and to create… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 371 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 29 May 2024
- How long will I take part?
- 10 Years
- 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: Patients being implanted with a ventricular assist device.
Who may be able to join
- Subject is ≥ 18 years of age
- Subject is treated with a VAD at the Butterworth Campus, Spectrum Health.
Who cannot join
- Subject is less than 18 years of age.
- Known prisoners of the state.
- Subject is pregnant.
- Non- English speaking patients will be excluded from the blood sub-study
Trial locations and contacts
1 site in 1 country.
United States1 site
Frederik Meijer Heart Center
Grand Rapids, Michigan, 49503
About this study
This study is meant to predict the outcome of VAD therapy, by forming a VAD registry for quality assessment, research, and real-time monitoring of patients on VAD therapy. The goal is to optimize the use of VAD therapy for patients, to create an online quality measurement tool for VAD treatment, and to create algorithms to estimate the prognosis for patients getting a VAD.
Read the detailed description
Patients eligible for VAD are being sampled before surgery for plasma as well as peripheral blood cells. After surgery patients are being sampled again at 24 h and 7 days. Inflammatory response is being monitored on gene expression as well as cell level and on cytokine level in relation to the outcome.
- Conditions
- Heart Failure
- Keywords
- Ventricular Assist Device
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
One year mortality
Mortality will be assessed yearly.
Measured: One year
Secondary outcomes (3)
Cytokine Analysis
Measured: Pre-implant, within 24 hours of implant, and 7 days post-implant
Inflammatory cell subtype
Measured: Pre-implant, within 24 hours of implant, and 7 days post-implant
Hospital readmissions
Measured: Will be assessed yearly until death or explant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study startFeb 2016
- Primary completion13 Oct 2021
- Study completion29 May 2024
Why it stopped: Study was not able to achieve primary objective and there is no intention to work towards its achievement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Enrolment
- 371 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renzo Loyaga Rendon, Corewell Health West
- Investigators
- Renzo Loyaga, MD PhD, Principal investigator, The DeVos Cardiovascular Research Program, Frederik Meijer Heart & Vascular Institute, Corewell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637242
- Sponsor's protocol ID
- 2015-073
- Status last verified
- Jun 2024
- First submitted
- 19 Apr 2016
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular Assist Device (VAD) Research Registry and Blood Sub-Study
- ClinicalTrials.gov ID
- NCT05637242
- Acronym / sponsor ID
- 2015-073
- Conditions
- Heart Failure
- Keywords
- Ventricular Assist Device
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was not able to achieve primary objective and there is no intention to work towards its achievement
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 5 Dec 2022 (actual)
- 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.
This study is meant to predict the outcome of VAD therapy, by forming a VAD registry for quality assessment, research, and real-time monitoring of patients on VAD therapy. The goal is to optimize the use of VAD therapy for patients, to create an online quality measurement tool for VAD treatment, and to create algorithms to estimate the prognosis for patients getting a VAD.
Detailed description
Patients eligible for VAD are being sampled before surgery for plasma as well as peripheral blood cells. After surgery patients are being sampled again at 24 h and 7 days. Inflammatory response is being monitored on gene expression as well as cell level and on cytokine level in relation to the outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being implanted with a ventricular assist device.
Key inclusion criteria (2 listed)
- Subject is ≥ 18 years of age
- Subject is treated with a VAD at the Butterworth Campus, Spectrum Health.
Key exclusion criteria (4 listed)
- Subject is less than 18 years of age.
- Known prisoners of the state.
- Subject is pregnant.
- Non- English speaking patients will be excluded from the blood sub-study
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
One year mortality
Time frame: One year
Mortality will be assessed yearly.
3 secondary outcomes
Cytokine Analysis
Time frame: Pre-implant, within 24 hours of implant, and 7 days post-implant
Inflammatory cell subtype
Time frame: Pre-implant, within 24 hours of implant, and 7 days post-implant
Hospital readmissions
Time frame: Will be assessed yearly until death or explant
Results and safety
The study was stopped early (reason given: Study was not able to achieve primary objective and there is no intention to work towards its achievement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Renzo Loyaga, MD PhD principal investigator
The DeVos Cardiovascular Research Program, Frederik Meijer Heart & Vascular Institute, Corewell Health
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 Heart Failure, run by Corewell Health West 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 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 5 Jun 2024. 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 was stopped early (reason given: Study was not able to achieve primary objective and there is no intention to work towards its achievement). 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?
One year mortality (time frame: One year). 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 Jun 2024.