Left Ventricular Failure, UnspecifiedAct-VADNCT04732039
Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Devices
A study testing Measurement of peak oxygen uptake in people with Left Ventricular Failure, Unspecified, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Investigation of oxygen uptake during daily life activities in HF patients with and without LVADs. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Left Ventricular Failure, Unspecified
- What is being tested?
- Measurement of peak oxygen uptake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Feb 2021to 31 Dec 2022
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Implanted durable left ventricular assist device
- Age>18yrs
- Signed informed consent
Who cannot join
- No consent
- Not able to complete VO2 test (physicians decision)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, DK, 2100
Kiran Mirza, MD, +4535451442, KiranMirza@dadlnet.dk
Finn Gustafsson, MD,PhD,DMSc., +4535459743, Finn.Gustafsson@regionh.dk
About this study
Official title: Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Device
Investigation of oxygen uptake during daily life activities in HF patients with and without LVADs.
Read the detailed description
In patients with terminal HF the gold standard for treatment is heart transplantation, though the Worldwide shortage of donor organs has led to increased use of implantable mechanical circulatory support devices. The treatment with implantable pumps in the form of a Continuous Flow Left Ventricular Assist Device (CF-LVAD, or simply LVAD) is extremely effective for a selected patient groups leading to significant improvement in survival and quality of life.
The device is a battery-powered flow pump that carries the blood from the left ventricle to the main artery, via a cannula, and thus relieves the failing left ventricle with up to 10 liters of blood per minute. An LVAD can be used both as lifelong support therapy (Destination Therapy, DT) or until transplantation can take place (Bridge therapy).
As patients today live for more than 10 years with the device as DT, the focus has shifted from mere survival to quality of life and physical ability.
In recent years, our research group showed that the pump speed and the patient's baseline heart rhythm (sinus rhythm vs atrial fibrillation) and reduced ability to regulate the intrinsic rhythm after implantation (chronotropic incompetence) are significant contributors to the reduced exercise capacity seen in this patient group.
Until now, studies have elucidated the work capacity of this patient group using a 6-minute walk test or bicycle test - none of these reflect how well the patient actually functions in his everyday life.
In this study, we will describe oxygen uptake related to specific daily activities (ADL-VO2) and compare these with the well-known maximum work capacity (percentage of expected oxygen uptake / pVO2) in this patient group.
- Conditions
- Left Ventricular Failure, Unspecified
- Being tested
- Measurement of peak oxygen uptake
- Keywords
- left ventricular assist device, oxygen uptake, daily life activity, quality of life
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of peak oxygen uptakeOther
Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).
| Study group | Role | What they receive |
|---|---|---|
| LVAD recipients | Experimental | Peak oxygen uptake vs VO2 measure during specific daily life activities in LVAD recipients Receives: Other: Measurement of peak oxygen uptake |
| Healthy controls | Experimental | Peak oxygen uptake vs VO2 measure during specific daily life activities in healthy controls. Receives: Other: Measurement of peak oxygen uptake |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2
Oxygen uptake
Measured: Stable LVAD recipients on average 2 years after the implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start8 Feb 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Failure, UnspecifiedStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover study: 1. Peak oxygen uptake vs VO2 measure during specific daily life activities in LVAD recipients 2. Peak oxygen uptake vs VO2 measure during specific daily life activities in healthy controls
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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,DMSci, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732039
- Sponsor's protocol ID
- H-20049568
- Acronym
- Act-VAD
- Status last verified
- Feb 2021
- First submitted
- 27 Jan 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Device
- ClinicalTrials.gov ID
- NCT04732039
- Acronym / sponsor ID
- Act-VAD / H-20049568
- Conditions
- Left Ventricular Failure, Unspecified
- Keywords
- left ventricular assist device, oxygen uptake, daily life activity, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Feb 2021 (actual)
- 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.
Investigation of oxygen uptake during daily life activities in HF patients with and without LVADs.
Detailed description
In patients with terminal HF the gold standard for treatment is heart transplantation, though the Worldwide shortage of donor organs has led to increased use of implantable mechanical circulatory support devices. The treatment with implantable pumps in the form of a Continuous Flow Left Ventricular Assist Device (CF-LVAD, or simply LVAD) is extremely effective for a selected patient groups leading to significant improvement in survival and quality of life.
The device is a battery-powered flow pump that carries the blood from the left ventricle to the main artery, via a cannula, and thus relieves the failing left ventricle with up to 10 liters of blood per minute. An LVAD can be used both as lifelong support therapy (Destination Therapy, DT) or until transplantation can take place (Bridge therapy).
As patients today live for more than 10 years with the device as DT, the focus has shifted from mere survival to quality of life and physical ability.
In recent years, our research group showed that the pump speed and the patient's baseline heart rhythm (sinus rhythm vs atrial fibrillation) and reduced ability to regulate the intrinsic rhythm after implantation (chronotropic incompetence) are significant contributors to the reduced exercise capacity seen in this patient group.
Until now, studies have elucidated the work capacity of this patient group using a 6-minute walk test or bicycle test - none of these reflect how well the patient actually functions in his everyday life.
In this study, we will describe oxygen uptake related to specific daily activities (ADL-VO2) and compare these with the well-known maximum work capacity (percentage of expected oxygen uptake / pVO2) in this patient group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover study: 1. Peak oxygen uptake vs VO2 measure during specific daily life activities in LVAD recipients 2. Peak oxygen uptake vs VO2 measure during specific daily life activities in healthy controls
| Arm | Type | Receives |
|---|---|---|
| LVAD recipients | Experimental | Other: Measurement of peak oxygen uptakePeak oxygen uptake vs VO2 measure during specific daily life activities in LVAD recipients |
| Healthy controls | Experimental | Other: Measurement of peak oxygen uptakePeak oxygen uptake vs VO2 measure during specific daily life activities in healthy controls. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Implanted durable left ventricular assist device
- Age>18yrs
- Signed informed consent
Key exclusion criteria (2 listed)
- No consent
- Not able to complete VO2 test (physicians decision)
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 |
|---|---|---|
| Measurement of peak oxygen uptakeOxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2). | Other | Healthy controls, LVAD recipients |
Primary outcome
VO2
Time frame: Stable LVAD recipients on average 2 years after the implantation
Oxygen uptake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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,DMSci 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 Measurement of peak oxygen uptake in people with Left Ventricular Failure, Unspecified, 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 2 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: status not confirmed, as of the sponsor's last update on 18 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kiran K Mirza, MD (+4535451442, KMIR0003@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 (time frame: Stable LVAD recipients on average 2 years after the implantation). 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 18 Feb 2021.