Biological Markers Predicting Exercise Capacity in CF-LVAD Patients.

Heart Failure Clinical Trial

Official title:

Biological Markers Predicting Exercise Capacity in Heart Failure Patients Supported With a Continuous-flow Left Ventricular Assist Device.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303236
• Other study ID #: H-1-2012-092-B
• Status: Completed
• Phase: N/A
• First received: November 20, 2014
• Last updated: October 3, 2017
• Start date: November 2014
• Est. completion date: December 24, 2016

Study information

• Verified date: October 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Establishing the association between biological markers and exercise capacity in continuous-flow left ventricular assist device patients.

Description:

The aim of this study is to investigate if specific biological markers can predict exercise capacity in advanced heart failure patients supported with continuous-flow left ventricular assist device patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 24, 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Stable CF-LVAD patients.

Exclusion Criteria:

• Unstable CF-LVAD patients.

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Denmark	University Hospital Rigshospitalet.	Copenhagen	Kbh Oe

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological markers	Analysis of blood will be carried out on all samples simultaneously, expected markers are pro-BNP, MRproANP, copeptin, Gal-3 and proADM.	Blood sampling on study day and samples are subsequently stored frozen.
Secondary	Exercise capacity	Exercise capacity will be estimated by peak VO2 measurements on a upright ergometer bike with breath-by-breath gas analysis.	Examination on study day. Patients will only be followed on the day of the study. Exercise testing is performed as the last intervention on the study day.