Heart FailureNCT02335684
Effects of Increased CF-LVAD Pump Speed During Sustained Submaximal Exercise
A study testing CF-LVAD pump speed baseline. and CF-LVAD pump speed increased. in people with Heart Failure, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This randomized trial has been designed to study if it is possible to enhance work capacity during submaximal efforts in heart failure patients supported with continuous-flow left ventricular assist devices (CF-LVAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- CF-LVAD pump speed baseline. and CF-LVAD pump speed increased.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Oct 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic and non-ischemic cardiomyopathy patients with CF-LVADs,signed informed consent.
Who cannot join
- Unstable patients, CF-LVAD implantation less than three months ago.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University Hospital of Copenhagen; Rigshospitalet.
Copenhagen Oe, 2100
About this study
Official title: Improving Functional Capacity in Heart Failure Patients Supported With Continuous-flow Left Ventricular Assist Devices. -Effects of Increased Pump Speed During Sustained Submaximal Exercise
This randomized trial has been designed to study if it is possible to enhance work capacity during submaximal efforts in heart failure patients supported with continuous-flow left ventricular assist devices (CF-LVAD).
The hypothesis is that exercise tolerability during low to moderate workloads in CF-LVAD patients can be increased when pump speed is increased soon after the onset of exercise.
Read the detailed description
To test the hypothesis described above the investigators will study submaximal exercise tests below anaerobic threshold in patients supported with CF-LVADs.Each patient will perform two tests- one with baseline CF-LVAD pump speed and the other with incrementally increased pump speed.
- Conditions
- Heart Failure
- Being tested
- CF-LVAD pump speed baseline., CF-LVAD pump speed increased.
- Keywords
- Heart-assist devices, exercise capacity
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CF-LVAD pump speed baseline.Other
Submaximal exercise test with baseline pump speed.
CF-LVAD pump speed increased.Other
Submaximal exercise test with increased pump speed (+800RPM).
| Study group | Role | What they receive |
|---|---|---|
| CF-LVAD patients. | Experimental | Patients are compared with themselves during submaximal exercise testing with baseline pump speed vs. submaximal exercise testing with increased pump speed. Receives: Other: CF-LVAD pump speed baseline.; Other: CF-LVAD pump speed increased. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise time
Exercise will be performed on a upright ergometer bike with simultaneously breath-by-breath gaz analysis.
Measured: Exercise time will be estimated only on the day of the study. No follow-up.
Secondary outcomes (1)
Perceived exertion
Rate of exertion will be estimated using the Borg Scale.
Measured: Perceived exertion will be estimated during exercise on the ergometer bike on the day of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startNov 2013
- Primary completionOct 2015
- Study completionOct 2015
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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation
- Responsible party
- Principal investigator, Finn Gustafsson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Finn Gustafsson, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335684
- Sponsor's protocol ID
- H-1-2013-103
- Status last verified
- Oct 2015
- First submitted
- 20 Jan 2014
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Functional Capacity in Heart Failure Patients Supported With Continuous-flow Left Ventricular Assist Devices. -Effects of Increased Pump Speed During Sustained Submaximal Exercise
- ClinicalTrials.gov ID
- NCT02335684
- Acronym / sponsor ID
- H-1-2013-103
- Conditions
- Heart Failure
- Keywords
- Heart-assist devices, exercise capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Heart Foundation
- Study start
- Nov 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Jan 2015 (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.
This randomized trial has been designed to study if it is possible to enhance work capacity during submaximal efforts in heart failure patients supported with continuous-flow left ventricular assist devices (CF-LVAD).
The hypothesis is that exercise tolerability during low to moderate workloads in CF-LVAD patients can be increased when pump speed is increased soon after the onset of exercise.
Detailed description
To test the hypothesis described above the investigators will study submaximal exercise tests below anaerobic threshold in patients supported with CF-LVADs.Each patient will perform two tests- one with baseline CF-LVAD pump speed and the other with incrementally increased pump speed.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF-LVAD patients. | Experimental | Other: CF-LVAD pump speed baseline., Other: CF-LVAD pump speed increased.Patients are compared with themselves during submaximal exercise testing with baseline pump speed vs. submaximal exercise testing with increased pump speed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ischemic and non-ischemic cardiomyopathy patients with CF-LVADs,signed informed consent.
Key exclusion criteria (1 listed)
- Unstable patients, CF-LVAD implantation less than three months ago.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CF-LVAD pump speed baseline.Submaximal exercise test with baseline pump speed. | Other | CF-LVAD patients. |
| CF-LVAD pump speed increased.Submaximal exercise test with increased pump speed (+800RPM). | Other | CF-LVAD patients. |
Primary outcome
Exercise time
Time frame: Exercise time will be estimated only on the day of the study. No follow-up.
Exercise will be performed on a upright ergometer bike with simultaneously breath-by-breath gaz analysis.
1 secondary outcome
Perceived exertion
Time frame: Perceived exertion will be estimated during exercise on the ergometer bike on the day of the study.
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 28 Oct 2015.
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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 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?
A study testing CF-LVAD pump speed baseline. and CF-LVAD pump speed increased. in people with 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 28 Oct 2015. 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?
Exercise time (time frame: Exercise time will be estimated only on the day of the study. No follow-up.). 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 28 Oct 2015.