Heart RatePace-VADNCT03844516
Pacing in Left Ventricular Assist Device Recipients
A study testing Peak oxygen uptake test with pacing and Peak oxygen uptake test without pacing in people with Heart Rate and Chronotropic Incompetence, run by Finn Gustafsson at 1 site in Denmark.
Trial summary
Implantation with left ventricular assist device (LVAD) in patients with end-stage heart failure (HF) leads to improvements in survival and quality of life, however, work capacity remains disappointingly low, at half of the expected value. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Rate, Chronotropic Incompetence, Pacing
- What is being tested?
- Peak oxygen uptake test with pacing and Peak oxygen uptake test without pacing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Apr 2019to 31 Jan 2021
- 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
- Implanted with a left ventricular assist device
- Implanted with a pace-device ensuring the possibility of pacing
- Age > 18
Who cannot join
- Not able to undergo a peak oxygen uptake test
- No consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, DK, 2100
Finn Gustafsson, MD, PhD, DMSc, 35459743, FinnG@dadlnet.dk
About this study
Official title: Work Intolerance in Left Ventricular Assist Device Recipients: Impact of Pacing
Implantation with left ventricular assist device (LVAD) in patients with end-stage heart failure (HF) leads to improvements in survival and quality of life, however, work capacity remains disappointingly low, at half of the expected value. Complex central and peripheral hallmarks of heart failure attribute to the continued work intolerance, to which heart rate may be a contributing factor.
The purpose of this study is to clarify the impact of heart rate (by means of pacing) on work capacity (measured as peak oxygen uptake) in LVAD recipients.
Read the detailed description
While implantation with left ventricular assist devices (LVADs) in patients with end-stage heart failure (HF) improve survival and quality of life, work capacity remains at a disappointing 50% of the expected value.
Due to the worldwide (increasing) shortage of donor hearts, LVADs are increasingly used as destination therapy which makes it crucial for physicians to persistently identify opportunities to improve management, lower the adverse events and maximize the benefits of this treatment option.
In recent years it was found that upregulation of device pump speed improves the maximal work capacity of LVAD recipients with no side effects. More recently it was found that the patients' heart rate reserve also was of importance in this regard, however, the latter was shown in a retrospective study and needs to be confirmed in a prospective randomized double-blinded intervention study. As a large portion of LVAD recipients are already implanted with a pacing device (and suffer from chronotropic incompetence) such a study is possible to conduct by controlling their heart rate during exercise by pacing (ie randomized crossover design).
- Conditions
- Heart Rate, Chronotropic Incompetence, Pacing
- Being tested
- Peak oxygen uptake test with pacing, Peak oxygen uptake test without pacing
- Keywords
- Chronotropic incompetence, pacing, heart rate, exercise, peak oxygen uptake
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peak oxygen uptake test with pacingOther
Also called Regulation of pace-device
Peak oxygen uptake test with paced heart rate
Peak oxygen uptake test without pacingOther
Also called Sham pacing
Peak oxygen uptake test without paced heart rate
| Study group | Role | What they receive |
|---|---|---|
| Peak oxygen uptake test with pacing | Other | Peak oxygen uptake test with pacing Receives: Other: Peak oxygen uptake test with pacing |
| Peak oxygen uptake test without pacing | Sham comparator | Peak VO2 test without pacing Receives: Other: Peak oxygen uptake test without pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake (pVO2)
Measured: 1 Day
Secondary outcomes (1)
Heart rate
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start23 Apr 2019
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart RateStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finn Gustafsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Finn Gustafsson, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844516
- Sponsor's protocol ID
- H-17029488
- Acronym
- Pace-VAD
- Status last verified
- May 2020
- First submitted
- 15 Feb 2019
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work Intolerance in Left Ventricular Assist Device Recipients: Impact of Pacing
- ClinicalTrials.gov ID
- NCT03844516
- Acronym / sponsor ID
- Pace-VAD / H-17029488
- Conditions
- Heart Rate, Chronotropic Incompetence, Pacing
- Keywords
- Chronotropic incompetence, pacing, heart rate, exercise, peak oxygen uptake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Finn GustafssonUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 18 Feb 2019 (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.
Implantation with left ventricular assist device (LVAD) in patients with end-stage heart failure (HF) leads to improvements in survival and quality of life, however, work capacity remains disappointingly low, at half of the expected value. Complex central and peripheral hallmarks of heart failure attribute to the continued work intolerance, to which heart rate may be a contributing factor.
The purpose of this study is to clarify the impact of heart rate (by means of pacing) on work capacity (measured as peak oxygen uptake) in LVAD recipients.
Detailed description
While implantation with left ventricular assist devices (LVADs) in patients with end-stage heart failure (HF) improve survival and quality of life, work capacity remains at a disappointing 50% of the expected value.
Due to the worldwide (increasing) shortage of donor hearts, LVADs are increasingly used as destination therapy which makes it crucial for physicians to persistently identify opportunities to improve management, lower the adverse events and maximize the benefits of this treatment option.
In recent years it was found that upregulation of device pump speed improves the maximal work capacity of LVAD recipients with no side effects. More recently it was found that the patients' heart rate reserve also was of importance in this regard, however, the latter was shown in a retrospective study and needs to be confirmed in a prospective randomized double-blinded intervention study. As a large portion of LVAD recipients are already implanted with a pacing device (and suffer from chronotropic incompetence) such a study is possible to conduct by controlling their heart rate during exercise by pacing (ie randomized crossover design).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peak oxygen uptake test with pacing | Other | Other: Peak oxygen uptake test with pacingPeak oxygen uptake test with pacing |
| Peak oxygen uptake test without pacing | Sham comparator | Other: Peak oxygen uptake test without pacingPeak VO2 test without pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Implanted with a left ventricular assist device
- Implanted with a pace-device ensuring the possibility of pacing
- Age > 18
Key exclusion criteria (2 listed)
- Not able to undergo a peak oxygen uptake test
- No consent
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 |
|---|---|---|
| Peak oxygen uptake test with pacingAlso: Regulation of pace-devicePeak oxygen uptake test with paced heart rate | Other | Peak oxygen uptake test with pacing |
| Peak oxygen uptake test without pacingAlso: Sham pacingPeak oxygen uptake test without paced heart rate | Other | Peak oxygen uptake test without pacing |
Primary outcome
Peak oxygen uptake (pVO2)
Time frame: 1 Day
1 secondary outcome
Heart rate
Time frame: 1 Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peak oxygen uptake test with pacing and Peak oxygen uptake test without pacing in people with Heart Rate and Chronotropic Incompetence, run by Finn Gustafsson 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 2 Jun 2020. 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. Some participants in this study may receive a placebo. 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 Finn Gustafsson, MD, PhD, DMSc. (34459743, FinnG@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (pVO2) (time frame: 1 Day). 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 2 Jun 2020.