Heart Failure.NCT01698398
The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device
A study testing Incremental pump speed of CF-LVAD. in people with Heart Failure., run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of the study is to examine the relationship between working capacity (peak oxygen consumption) and pump speed of continuous flow left ventricular assist devices (CF-LVADs)in heart failure patients. 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?
- Incremental pump speed of CF-LVAD.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Jan 2013
- 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
- Adult, Older adult
Who may be able to join
- HeartMate II patients who underwent surgery and follow-up at The Heart Centre of Rigshospitalet.
- Heart failure in stable phase without the need for intravenous inotropic therapy.
- Ischemic and non-ischemic cardiomyopathy.
Who cannot join
- Severe aortic insufficiency.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet.
Copenhagen, 2100
About this study
Official title: The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device.
The purpose of the study is to examine the relationship between working capacity (peak oxygen consumption) and pump speed of continuous flow left ventricular assist devices (CF-LVADs)in heart failure patients. The hypothesis is that it is possible to increase peak oxygen consumption by incrementally increasing CF-LVAD pumpspeed during exercise.
The study population will consist of severe heart failure patients with CF-LVADs treated at The Heart Centre of Copenhagen University Hospital Rigshospitalet.
- Conditions
- Heart Failure.
- Being tested
- Incremental pump speed of CF-LVAD.
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incremental pump speed of CF-LVAD.Device
Also called HeartMate II.
Peak oxygen consumption with fixed versus incremental pump speed.
| Study group | Role | What they receive |
|---|---|---|
| CF-LVAD pumpspeed. | Experimental | Optimal pumpspeed setting of CF-LVAD during exercise on ergometric bicycle. Receives: Device: Incremental pump speed of CF-LVAD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption.
ml oxygen/minute/kg
Measured: Day 1
Secondary outcomes (1)
Working capacity.
Watt
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure.Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698398
- Sponsor's protocol ID
- H-1-2012-092
- Status last verified
- Oct 2012
- First submitted
- 2 Oct 2012
- Last updated
- 11 Feb 2014
- Results posted
- No
Publications
Jung MH, Hansen PB, Sander K, Olsen PS, Rossing K, Boesgaard S, Russell SD, Gustafsson F. Effect of increasing pump speed during exercise on peak oxygen uptake in heart failure patients supported with a continuous-flow left ventricular assist device. A double-blind randomized study. Eur J Heart Fail. 2014 Apr;16(4):403-8. doi: 10.1002/ejhf.52.
PubMed 24464845
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device.
- ClinicalTrials.gov ID
- NCT01698398
- Acronym / sponsor ID
- H-1-2012-092
- Conditions
- Heart Failure.
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- First posted
- 3 Oct 2012 (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.
The purpose of the study is to examine the relationship between working capacity (peak oxygen consumption) and pump speed of continuous flow left ventricular assist devices (CF-LVADs)in heart failure patients. The hypothesis is that it is possible to increase peak oxygen consumption by incrementally increasing CF-LVAD pumpspeed during exercise.
The study population will consist of severe heart failure patients with CF-LVADs treated at The Heart Centre of Copenhagen University Hospital Rigshospitalet.
Study design
- Allocation
- Randomised
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF-LVAD pumpspeed. | Experimental | Device: Incremental pump speed of CF-LVAD.Optimal pumpspeed setting of CF-LVAD during exercise on ergometric bicycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HeartMate II patients who underwent surgery and follow-up at The Heart Centre of Rigshospitalet.
- Heart failure in stable phase without the need for intravenous inotropic therapy.
- Ischemic and non-ischemic cardiomyopathy.
Key exclusion criteria (1 listed)
- Severe aortic insufficiency.
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 |
|---|---|---|
| Incremental pump speed of CF-LVAD.Also: HeartMate II.Peak oxygen consumption with fixed versus incremental pump speed. | Device | CF-LVAD pumpspeed. |
Primary outcome
Peak oxygen consumption.
Time frame: Day 1
ml oxygen/minute/kg
1 secondary outcome
Working capacity.
Time frame: Day 1
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 11 Feb 2014.
- Derived from this study: PubMed 24464845Jung MH, Hansen PB, Sander K, Olsen PS, Rossing K, Boesgaard S, Russell SD, Gustafsson F. Effect of increasing pump speed during exercise on peak oxygen uptake in heart failure patients supported with a continuous-flow left ventricular assist device. A double-blind randomized study. Eur J Heart Fail. 2014 Apr;16(4):403-8. doi: 10.1002/ejhf.52.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incremental pump speed of CF-LVAD. 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 3 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 11 Feb 2014. 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?
Peak oxygen consumption. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01698398, which also lists 1 linked publication.
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 11 Feb 2014; AzTrials last refreshed its copy on 28 Oct 2026.