PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake (pVO2) in Recipients of Left Ventricular Assist Devices
NCT ID: NCT04423562
Last Updated: 2020-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2020-04-10
2022-12-31
Brief Summary
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The purpose is to investigate the prognostic value of VO2 in recipients of durable LVADs using data from studies already conducted.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Durable LVAD recipient with post implant VO2
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* VO2 in stable post implant phase
Exclusion Criteria
* Concomittant RVAD (temp/durable device)
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Finn Gustafsson
Professor
Principal Investigators
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Finn Gustafsson, MD,PhD,DMSci
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, DK, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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330131365/2
Identifier Type: -
Identifier Source: org_study_id
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