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PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake (pVO2) in Recipients of Left Ventricular Assist Devices

Investigation of the Prognostic Value of pVO2 in Recipients of Left Ventricular Assist Devices

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04423562
Acronym
PRO-VAD
Enrollment
500
Registered
2020-06-09
Start date
2020-04-10
Completion date
2022-12-31
Last updated
2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Heart Failure, Left Ventricular Assist Device, Prognosis

Brief 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.

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).

Interventions

OTHERNo intervention

No intervention

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Durable LVAD implantation * VO2 in stable post implant phase

Exclusion criteria

* No VO2 data available * Concomittant RVAD (temp/durable device)

Design outcomes

Primary

MeasureTime frameDescription
Outcome after implantationStable-phase post implant VO2 (e.g. >3months and up to 13 year post implant)Survival/ongiong on device/explant/htx after LVAD implantation

Countries

Denmark

Contacts

Primary ContactKiran Mirza, MD
KiranMirza@dadlnet.dk+4531679333
Backup ContactFinn Gustafsson, MD, PhD, DMSci
Finn.Gustafsson@regionh.dk+4535459743

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026