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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04423562
Other study ID # 330131365/2
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


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)
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