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

Prognosis Clinical Trial

— PRO-VAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423562
• Other study ID #: 330131365/2
• Status: Recruiting
• Start date: April 10, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2020
• Source: Rigshospitalet, Denmark
• Contact: Kiran Mirza, MD
• Phone: +4531679333
• Email: KiranMirza[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Durable LVAD implantation

• VO2 in stable post implant phase

Exclusion Criteria:

• No VO2 data available

• Concomittant RVAD (temp/durable device)

Related Conditions & MeSH terms

• Advanced Heart Failure
• Heart Failure
• Left Ventricular Assist Device
• Prognosis

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	DK

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)