NCT04423562

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

2.7 years

First QC Date

May 3, 2020

Last Update Submit

June 7, 2020

Conditions

Left Ventricular Assist DevicePrognosisAdvanced Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Outcome after implantation

    Survival/ongiong on device/explant/htx after LVAD implantation

    Stable-phase post implant VO2 (e.g. >3months and up to 13 year post implant)

Study Arms (1)

Durable LVAD recipient with post implant VO2

Other: No intervention

Interventions

No interventionOTHER

No intervention

Durable LVAD recipient with post implant VO2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients implanted with a durable LVAD (post-2006) and available post implant VO2 (stable phase) can be included in this study.

You may qualify if:

  • Durable LVAD implantation
  • VO2 in stable post implant phase

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, DK, 2100, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34391745DERIVED

Study Officials

  • Finn Gustafsson, MD,PhD,DMSci

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiran Mirza, MD

CONTACT

+4531679333KiranMirza@dadlnet.dk

Finn Gustafsson, MD, PhD, DMSci

CONTACT

+4535459743Finn.Gustafsson@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 3, 2020

First Posted

June 9, 2020

Study Start

April 10, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations

DK(1)