Left Ventricular Assist DevicePRO-VADNCT04423562
PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake (pVO2) in Recipients of Left Ventricular Assist Devices
An observational study of Left Ventricular Assist Device and Prognosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Pooling of earlier VO2-studies conducted at the dept. of cardiology, Rigshospitalet, Denmark, and all LVAD centres of the World that wish to participate. The purpose is to investigate the prognostic value of VO2 in recipients of durable LVADs using data from studies already conducted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Assist Device, Prognosis, Advanced Heart Failure
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Apr 2020to 31 Dec 2022
- 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: All patients implanted with a durable LVAD (post-2006) and available post implant VO2 (stable phase) can be included in this study.
Who may be able to join
- Durable LVAD implantation
- VO2 in stable post implant phase
Who cannot join
- No VO2 data available
- Concomittant RVAD (temp/durable device)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, DK, 2100
Kiran Mirza, MD, +4535451442, KiranMirza@dadlnet.dk
Finn Gustafsson, MD,PhD,DMSc., +4535459743, Finn.Gustafsson@regionh.dk
About this study
Official title: Investigation of the Prognostic Value of pVO2 in Recipients of Left Ventricular Assist Devices
Pooling of earlier VO2-studies conducted at the dept. of cardiology, Rigshospitalet, Denmark, and all LVAD centres of the World that wish to participate.
The purpose is to investigate the prognostic value of VO2 in recipients of durable LVADs using data from studies already conducted.
Read the detailed description
Background and purpose:
Peak oxygen uptake (pVO2) is used extensively in HF to predict prognosis and time for heart transplantation. Many centers are increasingly measuring pVO2 in LVAD supported HF patients, though this has mostly been for research or rehabilitation purposes. It is unknown if pVO2 predicts outcome in LVAD treated HF patients.
The investigators will pool data from all willing centers of the World to investigate the prognostic value of pVO2 (e.g. outcome in LVAD supported patients) and, secondly the investigators will investigate wether the predictive power of pVO2 in LVAD recipients depends on the treatment indication (BTT and DT).
Methods:
Data is collected in anonymized form from all centers willing to contribute data.
Hypothesis:
The hypothesis is that lower pVO2 is associated with higher rates of death or urgent transplantation (primary endpoint).
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Durable LVAD recipient with post implant VO2 | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome after implantation
Survival/ongiong on device/explant/htx after LVAD implantation
Measured: Stable-phase post implant VO2 (e.g. >3months and up to 13 year post implant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start10 Apr 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular Assist DeviceStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Finn Gustafsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Finn Gustafsson, MD,PhD,DMSci, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423562
- Sponsor's protocol ID
- 330131365/2
- Acronym
- PRO-VAD
- Status last verified
- Jun 2020
- First submitted
- 3 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mirza KK, Szymanski MK, Schmidt T, de Jonge N, Brahmbhatt DH, Billia F, Hsu S, MacGowan GA, Jakovljevic DG, Agostoni P, Trombara F, Jorde U, Rochlani Y, Vandersmissen K, Reiss N, Russell SD, Meyns B, Gustafsson F; PRO-VAD Investigators. Prognostic Value of Peak Oxygen Uptake in Patients Supported With Left Ventricular Assist Devices (PRO-VAD). JACC Heart Fail. 2021 Oct;9(10):758-767. doi: 10.1016/j.jchf.2021.05.021. Epub 2021 Aug 11.
PubMed 34391745
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Prognostic Value of pVO2 in Recipients of Left Ventricular Assist Devices
- ClinicalTrials.gov ID
- NCT04423562
- Acronym / sponsor ID
- PRO-VAD / 330131365/2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Jun 2020 (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.
Pooling of earlier VO2-studies conducted at the dept. of cardiology, Rigshospitalet, Denmark, and all LVAD centres of the World that wish to participate.
The purpose is to investigate the prognostic value of VO2 in recipients of durable LVADs using data from studies already conducted.
Detailed description
Background and purpose:
Peak oxygen uptake (pVO2) is used extensively in HF to predict prognosis and time for heart transplantation. Many centers are increasingly measuring pVO2 in LVAD supported HF patients, though this has mostly been for research or rehabilitation purposes. It is unknown if pVO2 predicts outcome in LVAD treated HF patients.
The investigators will pool data from all willing centers of the World to investigate the prognostic value of pVO2 (e.g. outcome in LVAD supported patients) and, secondly the investigators will investigate wether the predictive power of pVO2 in LVAD recipients depends on the treatment indication (BTT and DT).
Methods:
Data is collected in anonymized form from all centers willing to contribute data.
Hypothesis:
The hypothesis is that lower pVO2 is associated with higher rates of death or urgent transplantation (primary endpoint).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durable LVAD recipient with post implant VO2 | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients implanted with a durable LVAD (post-2006) and available post implant VO2 (stable phase) can be included in this study.
Key inclusion criteria (2 listed)
- Durable LVAD implantation
- VO2 in stable post implant phase
Key exclusion criteria (2 listed)
- No VO2 data available
- Concomittant RVAD (temp/durable device)
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 |
|---|---|---|
| No interventionNo intervention | Other | Durable LVAD recipient with post implant VO2 |
Primary outcome
Outcome after implantation
Time frame: Stable-phase post implant VO2 (e.g. >3months and up to 13 year post implant)
Survival/ongiong on device/explant/htx after LVAD implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 34391745Mirza KK, Szymanski MK, Schmidt T, de Jonge N, Brahmbhatt DH, Billia F, Hsu S, MacGowan GA, Jakovljevic DG, Agostoni P, Trombara F, Jorde U, Rochlani Y, Vandersmissen K, Reiss N, Russell SD, Meyns B, Gustafsson F; PRO-VAD Investigators. Prognostic Value of Peak Oxygen Uptake in Patients Supported With Left Ventricular Assist Devices (PRO-VAD). JACC Heart Fail. 2021 Oct;9(10):758-767. doi: 10.1016/j.jchf.2021.05.021. Epub 2021 Aug 11.
- Individual participant dataSharing planned: Undecided
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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.
Finn Gustafsson, MD,PhD,DMSci principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Left Ventricular Assist Device and Prognosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kiran Mirza, MD (+4531679333, KiranMirza@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome after implantation (time frame: Stable-phase post implant VO2 (e.g. >3months and up to 13 year post implant)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04423562, which also lists 1 linked publication.
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 9 Jun 2020.