Heart FailureNCT02303236
Biological Markers Predicting Exercise Capacity in CF-LVAD Patients.
An observational study of Heart Failure, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Establishing the association between biological markers and exercise capacity in continuous-flow left ventricular assist device patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to 24 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable CF-LVAD patients.
Who may be able to join
- Stable CF-LVAD patients.
Who cannot join
- Unstable CF-LVAD patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biological Markers Predicting Exercise Capacity in Heart Failure Patients Supported With a Continuous-flow Left Ventricular Assist Device.
Establishing the association between biological markers and exercise capacity in continuous-flow left ventricular assist device patients.
Read the detailed 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.
- Conditions
- Heart Failure
- Keywords
- Exercise
- Medical subject headings
- Heart Failure, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological markers
Analysis of blood will be carried out on all samples simultaneously, expected markers are pro-BNP, MRproANP, copeptin, Gal-3 and proADM.
Measured: Blood sampling on study day and samples are subsequently stored frozen.
Secondary outcomes (1)
Exercise capacity
Exercise capacity will be estimated by peak VO2 measurements on a upright ergometer bike with breath-by-breath gas analysis.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2016
- Study completion24 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Finn Gustafsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Finn Gustafsson, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303236
- Sponsor's protocol ID
- H-1-2012-092-B
- Status last verified
- Oct 2017
- First submitted
- 20 Nov 2014
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Markers Predicting Exercise Capacity in Heart Failure Patients Supported With a Continuous-flow Left Ventricular Assist Device.
- ClinicalTrials.gov ID
- NCT02303236
- Acronym / sponsor ID
- H-1-2012-092-B
- Conditions
- Heart Failure
- Keywords
- Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 24 Dec 2016 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Establishing the association between biological markers and exercise capacity in continuous-flow left ventricular assist device patients.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable CF-LVAD patients.
Key inclusion criteria (1 listed)
- Stable CF-LVAD patients.
Key exclusion criteria (1 listed)
- Unstable CF-LVAD patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biological markers
Time frame: Blood sampling on study day and samples are subsequently stored frozen.
Analysis of blood will be carried out on all samples simultaneously, expected markers are pro-BNP, MRproANP, copeptin, Gal-3 and proADM.
1 secondary outcome
Exercise capacity
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finn Gustafsson, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological markers (time frame: Blood sampling on study day and samples are subsequently stored frozen.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.