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

• Conditions: Prognosis; Advanced Heart Failure; Left Ventricular Assist Device
• Interventions: Other: No intervention

• Registration Number: NCT04423562
• Lead Sponsor: Rigshospitalet, Denmark

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).

Study Timeline

• Study Start: 2020-04-10
• Study First Submitted: 2020-05-03
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-07
• Last Update Submitted: 2020-06-07
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Durable LVAD implantation
• VO2 in stable post implant phase

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Durable LVAD recipient with post implant VO2	No intervention	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, DK, Denmark