Chronotropic IncompetenceADAPTIONNCT03235843
Rate Adaptive Atrial Pacing in Heart Failure
A study testing AAIR pacing and DDI-pacing in people with Chronotropic Incompetence and Heart Failure, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over pilot study in a multi-center setting. Aim: to assess the ability of minute ventilation (MV) sensor driven rate adaptive atrial stimulation to restore functional capacity and quality of life in heart failure patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronotropic Incompetence, Heart Failure, ICD
- What is being tested?
- AAIR pacing and DDI-pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2017to 1 Dec 2019
- 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
- Chronotropic incompetence as assessed by a modified Heart Rate Score (mHRS)
- Implanted with a Boston Scientific dual chamber ICD equipped with minute ventilation sensor
- Symptomatic congestive heart failure (NYHA class II-III)
- Left ventricular systolic dysfunction (LVEF <35%)
- Optimal medical therapy
- Sinus rhythm
- Subjects should be able to perform normal daily activities
Who cannot join
- Age <18 or incapacitated adult
- Documented atrial fibrillation in the last 3 months prior to inclusion
- Indication for pacing (SSS, AV conduction abnormalities requiring pacing)
- Respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator
- Patients who are unable to tolerate increased pacing rates
- Indication for cardiac resynchronization therapy
- Beta-blocker / ivabradine / amiodarone therapy is not an exclusion criterion
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
VU university medical center
Amsterdam, 1081HV
Anne-Lotte van der Lingen, MD, +31204443272, a.vanderlingen@vumc.nl
About this study
Official title: Rate Adaptive Atrial Pacing in Heart Failure Patients With Chronotropic Incompetence
The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over pilot study in a multi-center setting.
Aim: to assess the ability of minute ventilation (MV) sensor driven rate adaptive atrial stimulation to restore functional capacity and quality of life in heart failure patients with chronotropic incompetence.
Methods: heart failure patients (left ventricular ejection fraction ≤35% \& New York Heart Assessment II or III) who were implanted with a 2-chamber implantable cardioverter defibrillator (ICD) device equipped with a MV sensor that are diagnosed with chronotropic incompetence will be included in the study. Patients will be randomized in a 1:1 fashion to rate responsive pacing (MV sensor only) function ON (AAIR mode) or OFF (DDI mode). After 3 months the pacing mode will be switched to the opposite mode.
- Conditions
- Chronotropic Incompetence, Heart Failure, ICD
- Being tested
- AAIR pacing, DDI-pacing
- Keywords
- Chronotropic Incompetence, Rate Adaptive Pacing, Minute Ventilation Sensor, Primary Prevention ICD Therapy, Implantable Cardioverter Defibrillator, Heart Failure, Exercise Intolerance
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAIR pacingDevice
Rate adaptive pacing using a MV sensor.
DDI-pacingDevice
Rate adaptive pacing OFF
| Study group | Role | What they receive |
|---|---|---|
| Rate Adaptive Pacing ON | Active comparator | AAIR pacing using a MV sensor Receives: Device: AAIR pacing |
| Rate Adaptive Pacing OFF | Placebo comparator | DDI-pacing Receives: Device: DDI-pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of quality of life
Measured with the Minnesota Living with Heart Failure Questionnaire
Measured: 3 months after changing the pacing mode
Secondary outcomes (4)
Improvement of functional capacity
Measured with a six-minute walk test
Measured: 3 months after changing the pacing mode
Reversibility of chronotropic incompetence
A comparison of the modified HeartRateScore with and without rate adaptive pacing.
Measured: 3 months after changing the pacing mode
Clinical status
Measured with NYHA class assessment and number of hospitalizations for heart failure.
Measured: 3 months after changing the pacing mode
Daily activity level
Measured with the device's accelerometer
Measured: 3 months after changing the pacing mode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 Aug 2017
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
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 Chronotropic IncompetenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients enter a double blind randomized cross-over pilot study and will be randomized in a 1:1 fashion to either rate responsive (MV sensor only) function on or off. After 3 months the pacing mode will be switched to the opposite mode.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Maasstad Hospital, Northwest Clinics Alkmaar
- Responsible party
- Principal investigator, Cornelis P. Allaart, Amsterdam UMC, location VUmc
- Investigators
- Cornelis P Allaart, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235843
- Sponsor's protocol ID
- ISROTH20232
- Acronym
- ADAPTION
- Status last verified
- Aug 2017
- First submitted
- 10 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brubaker PH, Kitzman DW. Chronotropic incompetence: causes, consequences, and management. Circulation. 2011 Mar 8;123(9):1010-20. doi: 10.1161/CIRCULATIONAHA.110.940577. No abstract available.
PubMed 21382903
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate Adaptive Atrial Pacing in Heart Failure Patients With Chronotropic Incompetence
- ClinicalTrials.gov ID
- NCT03235843
- Acronym / sponsor ID
- ADAPTION / ISROTH20232
- Conditions
- Chronotropic Incompetence, Heart Failure, ICD
- Keywords
- Chronotropic Incompetence, Rate Adaptive Pacing, Minute Ventilation Sensor, Primary Prevention ICD Therapy, Implantable Cardioverter Defibrillator, Heart Failure, Exercise Intolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- UMC Utrecht, Maasstad Hospital, Northwest Clinics Alkmaar
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 1 Aug 2017 (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.
The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over pilot study in a multi-center setting.
Aim: to assess the ability of minute ventilation (MV) sensor driven rate adaptive atrial stimulation to restore functional capacity and quality of life in heart failure patients with chronotropic incompetence.
Methods: heart failure patients (left ventricular ejection fraction ≤35% \& New York Heart Assessment II or III) who were implanted with a 2-chamber implantable cardioverter defibrillator (ICD) device equipped with a MV sensor that are diagnosed with chronotropic incompetence will be included in the study. Patients will be randomized in a 1:1 fashion to rate responsive pacing (MV sensor only) function ON (AAIR mode) or OFF (DDI mode). After 3 months the pacing mode will be switched to the opposite mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients enter a double blind randomized cross-over pilot study and will be randomized in a 1:1 fashion to either rate responsive (MV sensor only) function on or off. After 3 months the pacing mode will be switched to the opposite mode.
| Arm | Type | Receives |
|---|---|---|
| Rate Adaptive Pacing ON | Active comparator | Device: AAIR pacingAAIR pacing using a MV sensor |
| Rate Adaptive Pacing OFF | Placebo comparator | Device: DDI-pacingDDI-pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronotropic incompetence as assessed by a modified Heart Rate Score (mHRS)
- Implanted with a Boston Scientific dual chamber ICD equipped with minute ventilation sensor
- Symptomatic congestive heart failure (NYHA class II-III)
- Left ventricular systolic dysfunction (LVEF <35%)
- Optimal medical therapy
Key exclusion criteria (7 listed)
- Age <18 or incapacitated adult
- Documented atrial fibrillation in the last 3 months prior to inclusion
- Indication for pacing (SSS, AV conduction abnormalities requiring pacing)
- Respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator
- Patients who are unable to tolerate increased pacing rates
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 |
|---|---|---|
| AAIR pacingRate adaptive pacing using a MV sensor. | Device | Rate Adaptive Pacing ON |
| DDI-pacingRate adaptive pacing OFF | Device | Rate Adaptive Pacing OFF |
Primary outcome
Improvement of quality of life
Time frame: 3 months after changing the pacing mode
Measured with the Minnesota Living with Heart Failure Questionnaire
4 secondary outcomes
Improvement of functional capacity
Time frame: 3 months after changing the pacing mode
Reversibility of chronotropic incompetence
Time frame: 3 months after changing the pacing mode
Clinical status
Time frame: 3 months after changing the pacing mode
Daily activity level
Time frame: 3 months after changing the pacing mode
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Background: PubMed 21382903Brubaker PH, Kitzman DW. Chronotropic incompetence: causes, consequences, and management. Circulation. 2011 Mar 8;123(9):1010-20. doi: 10.1161/CIRCULATIONAHA.110.940577. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Chronotropic Incompetence
Recruiting
SHort Of Pace - Heart Failure (SHOP-HF)
Heart Failure With Preserved Ejection Fraction
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.
Cornelis P Allaart, MD, PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAIR pacing and DDI-pacing in people with Chronotropic Incompetence and Heart Failure, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 7 inclusion and 7 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 Aug 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 Netherlands. 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 Cornelis P Allaart, MD, PhD (+31 (0)20 4445043, cp.allaart@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of quality of life (time frame: 3 months after changing the pacing mode). 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 NCT03235843, 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 2 Aug 2017.