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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Recruiting

CT.gov ID

NCT04423562

Collaborator

(none)

500

Enrollment

Location

32.7

Anticipated Duration (Months)

15.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Left Ventricular Assist Device Prognosis Advanced Heart Failure	Other: No intervention

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

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 10, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Durable LVAD recipient with post implant VO2

Other: No intervention

No intervention

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Durable LVAD implantation
VO2 in stable post implant phase

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen	DK	Denmark	2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator: Finn Gustafsson, MD,PhD,DMSci, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Finn Gustafsson, Professor, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT04423562

Other Study ID Numbers:

330131365/2

First Posted:

Jun 9, 2020

Last Update Posted:

Jun 9, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Jun 9, 2020