Chronic Heart FailurePhase 2OPT-CNCT02964650
Optimising Pacemaker Therapy for Contractility
A Phase 2 study testing Personalised rate-response settings in people with Chronic Heart Failure, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Personalised rate-response settings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2017to 31 Oct 2019
- Phase
- Phase 2
- 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
- Symptomatic CHF due to left ventricular systolic dysfunction (LVEF<45%),
- Cardiac pacemaker,
- Able to perform a peak exercise test,
- Willing and able to give informed consent.
Who cannot join
- Angina pectoris symptoms limiting exercise tolerance,
- Unstable heart failure symptoms (medical therapy changes in last three months), Poor image quality,
- Calcium channel blockers (CCBs).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of Optimising Pacemaker Heart Rate for Contractility: Effects on Walk Time, Cardiac Remodelling and Quality of Life.
The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF). They have also demonstrated in an acute cross-over study that keeping the heart rate in this range (versus standard rate-response programming) in patients with CHF is associated with increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a randomised, placebo-controlled trial whether optimal programming versus standard rate-response programming for 6 months leads to appreciable improvements in exercise time and quality of life, while having no adverse effects on left ventricular function and battery longevity.
60 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic assessment to establish the force frequency relationship and the optimal heart rate for contractility. They will then perform a treadmill walk test and fill out a quality of life questionnaire. They will then be randomised to optimal rate-response settings or standard rate response settings and followed up at 6 months at which point the tests will be repeated.
Read the detailed description
Design: This will be a randomised, double-blind 'placebo' controlled trial of optimised programming versus standard rate-response settings, aiming to determine whether the short term improvements translate into longer term benefits.
Study participants: 60 adult patients (>18years) aiming for 50 matched datasets (25 in each arm).
Study Procedures: Patients attending the heart failure clinic, the pacemaker clinic or previous participants in the acute cross-over study (pilot data 2) will be approached with a standard letter and information sheet and then a telephone call to make sure any remaining questions are answered.
Patients agreeing to participate will attend the clinical research facility (CRF) and will be asked to sign a consent form. Each patient will have a standard device check, check of their demographic data, and co-morbidities. The investigators will record a resting cardiac ultrasound, and, in those who did not participate in the pilot study (or did so more than six months previously), we will measure the force frequency relationship (FFR) as described to determine critical heart rate (HR), and the optimal range of HR rise. All images will be stored for offline analysis. Participants will then be asked to do a symptom-limited walk test on the treadmill (until they cannot do any more). At this first visit, participants will also complete a quality of life questionnaire. All of these activities will take place in the Clinical Research Facility at Leeds General Infirmary.
Randomisation: Each patient will then be randomised to either optimised programming (n=30) as predicted by their force-frequency curve or standard settings (n=30). In the optimised group, programming will keep heart rates below the critical HR. Randomisation will be by a random number generator and programming will be undertaken by one of my colleagues to maintain blinding.
Follow-up: Each patient will be called at one month to check that they are tolerating any changes and will then be invited back at 6 months for a repeat resting echocardiogram, treadmill walk test and quality of life assessment.
Data: All data will be stored on a bespoke Excel spreadsheet on an LTHT server in a password-protected folder.
Primary Endpoint: The effects of heart rate programming that optimises heart rate for contractility on change in treadmill-based walk distance over six months in patients with heart failure and a pacemaker.
Secondary endpoints: 1) the safety of pacemaker programming optimised for heart rate in patients with heart failure and a pacemaker, 2) the effect of this programming on change of quality of life at 6 months 3) the effect of this programming on change in cardiac function at 6 months.
- Conditions
- Chronic Heart Failure
- Being tested
- Personalised rate-response settings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised rate-response settingsDevice
Rate response range fixed to limits suggested by force-frequency curve
| Study group | Role | What they receive |
|---|---|---|
| Standard rate-response settings | No intervention | Patients allocated to standard rate-response settings. |
| Personalised rate-response settings | Experimental | Patients allocated to optimised rate-response settings. Receives: Device: Personalised rate-response settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treadmill walk time
Time walked during a standard incremental treadmill test
Measured: 6 months
Secondary outcomes (3)
Quality of life
EQ5D-5L
Measured: 6 months
Left ventricular function by echocardiography
Measured: 6 months
Battery longevity
Measured in years remaining at current settings
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start20 Jun 2017
- Primary completion30 Sep 2019
- Study completion31 Oct 2019
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 Chronic Heart FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KK Witte, University of Leeds
- Investigators
- Klaus Witte, MD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964650
- Sponsor's protocol ID
- IRAS 218963
- Acronym
- OPT-C
- Status last verified
- Mar 2020
- First submitted
- 8 Nov 2016
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gierula J, Lowry JE, Paton MF, Cole CA, Byrom R, Koshy AO, Chumun H, Kearney LC, Straw S, Bowen TS, Cubbon RM, Keenan AM, Stocken DD, Kearney MT, Witte KK. Personalized Rate-Response Programming Improves Exercise Tolerance After 6 Months in People With Cardiac Implantable Electronic Devices and Heart Failure: A Phase II Study. Circulation. 2020 May 26;141(21):1693-1703. doi: 10.1161/CIRCULATIONAHA.119.045066. Epub 2020 Apr 17.
PubMed 32299222
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Optimising Pacemaker Heart Rate for Contractility: Effects on Walk Time, Cardiac Remodelling and Quality of Life.
- ClinicalTrials.gov ID
- NCT02964650
- Acronym / sponsor ID
- OPT-C / IRAS 218963
- Conditions
- Chronic Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 16 Nov 2016 (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 investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF). They have also demonstrated in an acute cross-over study that keeping the heart rate in this range (versus standard rate-response programming) in patients with CHF is associated with increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a randomised, placebo-controlled trial whether optimal programming versus standard rate-response programming for 6 months leads to appreciable improvements in exercise time and quality of life, while having no adverse effects on left ventricular function and battery longevity.
60 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic assessment to establish the force frequency relationship and the optimal heart rate for contractility. They will then perform a treadmill walk test and fill out a quality of life questionnaire. They will then be randomised to optimal rate-response settings or standard rate response settings and followed up at 6 months at which point the tests will be repeated.
Detailed description
Design: This will be a randomised, double-blind 'placebo' controlled trial of optimised programming versus standard rate-response settings, aiming to determine whether the short term improvements translate into longer term benefits.
Study participants: 60 adult patients (>18years) aiming for 50 matched datasets (25 in each arm).
Study Procedures: Patients attending the heart failure clinic, the pacemaker clinic or previous participants in the acute cross-over study (pilot data 2) will be approached with a standard letter and information sheet and then a telephone call to make sure any remaining questions are answered.
Patients agreeing to participate will attend the clinical research facility (CRF) and will be asked to sign a consent form. Each patient will have a standard device check, check of their demographic data, and co-morbidities. The investigators will record a resting cardiac ultrasound, and, in those who did not participate in the pilot study (or did so more than six months previously), we will measure the force frequency relationship (FFR) as described to determine critical heart rate (HR), and the optimal range of HR rise. All images will be stored for offline analysis. Participants will then be asked to do a symptom-limited walk test on the treadmill (until they cannot do any more). At this first visit, participants will also complete a quality of life questionnaire. All of these activities will take place in the Clinical Research Facility at Leeds General Infirmary.
Randomisation: Each patient will then be randomised to either optimised programming (n=30) as predicted by their force-frequency curve or standard settings (n=30). In the optimised group, programming will keep heart rates below the critical HR. Randomisation will be by a random number generator and programming will be undertaken by one of my colleagues to maintain blinding.
Follow-up: Each patient will be called at one month to check that they are tolerating any changes and will then be invited back at 6 months for a repeat resting echocardiogram, treadmill walk test and quality of life assessment.
Data: All data will be stored on a bespoke Excel spreadsheet on an LTHT server in a password-protected folder.
Primary Endpoint: The effects of heart rate programming that optimises heart rate for contractility on change in treadmill-based walk distance over six months in patients with heart failure and a pacemaker.
Secondary endpoints: 1) the safety of pacemaker programming optimised for heart rate in patients with heart failure and a pacemaker, 2) the effect of this programming on change of quality of life at 6 months 3) the effect of this programming on change in cardiac function at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard rate-response settings | No intervention | –Patients allocated to standard rate-response settings. |
| Personalised rate-response settings | Experimental | Device: Personalised rate-response settingsPatients allocated to optimised rate-response settings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic CHF due to left ventricular systolic dysfunction (LVEF<45%),
- Cardiac pacemaker,
- Able to perform a peak exercise test,
- Willing and able to give informed consent.
Key exclusion criteria (3 listed)
- Angina pectoris symptoms limiting exercise tolerance,
- Unstable heart failure symptoms (medical therapy changes in last three months), Poor image quality,
- Calcium channel blockers (CCBs).
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 |
|---|---|---|
| Personalised rate-response settingsRate response range fixed to limits suggested by force-frequency curve | Device | Personalised rate-response settings |
Primary outcome
Treadmill walk time
Time frame: 6 months
Time walked during a standard incremental treadmill test
3 secondary outcomes
Quality of life
Time frame: 6 months
Left ventricular function by echocardiography
Time frame: 6 months
Battery longevity
Time frame: 6 months
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 25 Mar 2020.
- Derived from this study: PubMed 32299222Gierula J, Lowry JE, Paton MF, Cole CA, Byrom R, Koshy AO, Chumun H, Kearney LC, Straw S, Bowen TS, Cubbon RM, Keenan AM, Stocken DD, Kearney MT, Witte KK. Personalized Rate-Response Programming Improves Exercise Tolerance After 6 Months in People With Cardiac Implantable Electronic Devices and Heart Failure: A Phase II Study. Circulation. 2020 May 26;141(21):1693-1703. doi: 10.1161/CIRCULATIONAHA.119.045066. Epub 2020 Apr 17.
- Individual participant dataSharing planned: Undecided
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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.
Klaus Witte, MD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Personalised rate-response settings in people with Chronic Heart Failure, run by University of Leeds at 1 site in United Kingdom.
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 4 inclusion and 3 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 25 Mar 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 United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Treadmill walk time (time frame: 6 months). 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 NCT02964650, 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 25 Mar 2020.