NCT02303236

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2016

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

2.1 years

First QC Date

November 20, 2014

Last Update Submit

October 3, 2017

Conditions

Heart Failure

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Exercise capacity

    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.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stable CF-LVAD patients.

You may qualify if:

  • Stable CF-LVAD patients.

You may not qualify if:

  • Unstable CF-LVAD patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Rigshospitalet.

Copenhagen, Kbh Oe, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples in biological bank.

MeSH Terms

Conditions

Heart FailureMotor Activity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Finn Gustafsson, MD, PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 27, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 24, 2016

Last Updated

October 5, 2017

Record last verified: 2017-10

Locations

DK(1)