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

Rigshospitalet logo

Rigshospitalet

Status

Unknown

Conditions

Left Ventricular Assist Device
Prognosis
Advanced Heart Failure

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04423562
330131365/2

Details and patient eligibility

About

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.

Full 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).

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Durable LVAD implantation
  • VO2 in stable post implant phase

Exclusion criteria

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

Trial design

500 participants in 1 patient group

Durable LVAD recipient with post implant VO2
Treatment:
Other: No intervention

Trial contacts and locations

1

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Central trial contact

Kiran Mirza, MD; Finn Gustafsson, MD, PhD, DMSci

Data sourced from clinicaltrials.gov

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