Atrial FibrillationPhase 1NCT03987204
Ivabradine for Rate Control in Permanent Atrial Fibrillation
A Phase 1 study testing Ivabradine in people with Atrial Fibrillation and Atrial Fibrillation, Persistent, run by Yale University at 1 site in United States.
Trial summary
Ivabradine may be useful as a rate controlling agent in atrial fibrillation without negative effects on hemodynamics and inotropy. The objective in this proof of concept study is to investigate the hypothesis that ivabradine will slow the ventricular response in patients with permanent atrial fibrillation and… Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Atrial Fibrillation, Persistent
- What is being tested?
- Ivabradine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2019to 17 Sep 2019
- Phase
- Phase 1
- 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 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with stable blood pressures with permanent atrial fibrillation and implanted pacemaker pacing less than 50% of the time, with or without concomitant beta blocker or calcium channel blocker use
Who cannot join
- Patients with uncontrolled hypertension will be excluded
- To eliminate confounding effects, patients on Digoxin therapy will be excluded
- Patients on anti-arrhythmic therapy
- Patients with pre-excitation on EKG
- Patients who pace > 50% of the time
- Patients with severe Child-Pugh C hepatic impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06405
About this study
Ivabradine may be useful as a rate controlling agent in atrial fibrillation without negative effects on hemodynamics and inotropy. The objective in this proof of concept study is to investigate the hypothesis that ivabradine will slow the ventricular response in patients with permanent atrial fibrillation and previously-implanted pacemakers.
Read the detailed description
In a simple cross-over study, the investigators will evaluate the impact of oral Ivabradine on exercise treadmill test, percent pacing as stored in pacemaker diagnostics, and 6 minute walk test.
Aim/Hypotheses
- To determine if the addition of Ivabradine to baseline cardiac medications slows mean and maximum heart rates in permanent atrial fibrillation
- Ivabradine will lower mean and maximum heart rates on treadmill exercise test, without lowering blood pressure
- Ivabradine will increase percent pacing, and lower rates over time as shown on pacemaker diagnostic data
- Ivabradine will improve exertional symptoms and exercise tolerance due to atrial fibrillation as measured by the Borg's scale during a six-minute walk test.
Study Design
- Patients with permanent atrial fibrillation will undergo baseline exercise treadmill test, measurement of heart rates and percent pacing from pacemaker diagnostics, and a 6 minute walk test with symptomatic assessment of dyspnea using the Borg's scale score.
- Oral Ivabradine will be started at 5 mg twice daily, and up-titrated to a maximum dose of 7.5 mg twice daily at 7 days if percent pacing has not increased significantly or rates have not slowed more than 20bpm.
- Exercise treadmill test, measurement of heart rates and percent pacing from pacemaker diagnostics, and a 6 minute walk test with symptomatic assessment of dyspnea using the Borg's scale score will be repeated at 2 weeks.
- Being tested
- Ivabradine
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Ivabradine will be started and titrated to heart rate slowing of 20 bpm or greater, or an increase in pacing.
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine | Experimental | Patients with permanent atrial fibrillation and previously implanted pacemakers who will be started on ivabradine. Receives: Drug: Ivabradine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate in Daily Life
Average ventricular heart rate derived using pacemaker interrogation over 2 weeks
Measured: 2 weeks
Percent Pacing in Daily Life
Average percent pacing derived using pacemaker interrogation over 2 weeks
Measured: 2 weeks
Heart Rate on Treadmill
Average ventricular heart rate will be recorded after the patient exercises on a treadmill using a heart rate monitor
Measured: 2 weeks
Symptoms and Exercise Tolerance
Patients will undergo a 6 minute walk test, and symptoms and distance walked as measured by standard 6 minute walk protocol
Measured: 2 weeks
Secondary outcomes (1)
Blood Pressure
Blood pressures will be monitored using a blood pressure cuff with the patient at rest for 10 minutes
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start15 Jun 2019
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Lampert, MD, Principal investigator, Yale UniversityHyon Jae Lee, MD, Study director, Yale New Haven Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987204
- Sponsor's protocol ID
- 2000022064
- Status last verified
- Jun 2021
- First submitted
- 31 May 2019
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivabradine for Rate Control in Permanent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03987204
- Acronym / sponsor ID
- 2000022064
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 14 Jun 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.
Ivabradine may be useful as a rate controlling agent in atrial fibrillation without negative effects on hemodynamics and inotropy. The objective in this proof of concept study is to investigate the hypothesis that ivabradine will slow the ventricular response in patients with permanent atrial fibrillation and previously-implanted pacemakers.
Detailed description
In a simple cross-over study, the investigators will evaluate the impact of oral Ivabradine on exercise treadmill test, percent pacing as stored in pacemaker diagnostics, and 6 minute walk test.
Aim/Hypotheses
- To determine if the addition of Ivabradine to baseline cardiac medications slows mean and maximum heart rates in permanent atrial fibrillation
- Ivabradine will lower mean and maximum heart rates on treadmill exercise test, without lowering blood pressure
- Ivabradine will increase percent pacing, and lower rates over time as shown on pacemaker diagnostic data
- Ivabradine will improve exertional symptoms and exercise tolerance due to atrial fibrillation as measured by the Borg's scale during a six-minute walk test.
Study Design
- Patients with permanent atrial fibrillation will undergo baseline exercise treadmill test, measurement of heart rates and percent pacing from pacemaker diagnostics, and a 6 minute walk test with symptomatic assessment of dyspnea using the Borg's scale score.
- Oral Ivabradine will be started at 5 mg twice daily, and up-titrated to a maximum dose of 7.5 mg twice daily at 7 days if percent pacing has not increased significantly or rates have not slowed more than 20bpm.
- Exercise treadmill test, measurement of heart rates and percent pacing from pacemaker diagnostics, and a 6 minute walk test with symptomatic assessment of dyspnea using the Borg's scale score will be repeated at 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivabradine | Experimental | Drug: IvabradinePatients with permanent atrial fibrillation and previously implanted pacemakers who will be started on ivabradine. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with stable blood pressures with permanent atrial fibrillation and implanted pacemaker pacing less than 50% of the time, with or without concomitant beta blocker or calcium channel blocker use
Key exclusion criteria (6 listed)
- Patients with uncontrolled hypertension will be excluded
- To eliminate confounding effects, patients on Digoxin therapy will be excluded
- Patients on anti-arrhythmic therapy
- Patients with pre-excitation on EKG
- Patients who pace > 50% of the time
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 |
|---|---|---|
| IvabradineIvabradine will be started and titrated to heart rate slowing of 20 bpm or greater, or an increase in pacing. | Drug | Ivabradine |
Primary outcome
Heart Rate in Daily Life
Time frame: 2 weeks
Average ventricular heart rate derived using pacemaker interrogation over 2 weeks
Percent Pacing in Daily Life
Time frame: 2 weeks
Average percent pacing derived using pacemaker interrogation over 2 weeks
Heart Rate on Treadmill
Time frame: 2 weeks
Average ventricular heart rate will be recorded after the patient exercises on a treadmill using a heart rate monitor
Symptoms and Exercise Tolerance
Time frame: 2 weeks
Patients will undergo a 6 minute walk test, and symptoms and distance walked as measured by standard 6 minute walk protocol
1 secondary outcome
Blood Pressure
Time frame: 2 weeks
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 2 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Rachel Lampert, MD principal investigator
Yale University
Hyon Jae Lee, MD study director
Yale New Haven Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ivabradine in people with Atrial Fibrillation and Atrial Fibrillation, Persistent, run by Yale University at 1 site in United States.
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 1 inclusion and 6 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 2 Jul 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Heart Rate in Daily Life (time frame: 2 weeks). The study lists 4 primary outcomes in all. 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 Jul 2021.