Atrial FibrillationPhase 3NCT00225667
Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension and Permanent Pacemakers
A Phase 3 study testing Irbesartan in people with Atrial Fibrillation and Hypertension, run by Connolly, Stuart, M.D. at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether irbesartan will reduce the rate of recurrent atrial high rate episodes and the development of clinical sustained atrial fibrillation in patients with hypertension and permanent pacemaker. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Hypertension
- What is being tested?
- Irbesartan
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2005to Jul 2007
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sinus Node Dysfunction (with or without AV conduction disturbance)
- Permanent, atrial or dual-chamber pacemaker implanted > 2 months before enrollment and with ability to record and store atrial high-rate episodes, frequency of mode switches and to perform non-invasive electrophysiologic testing
- History of at least 6 AHRE in the last 6 months (rate > 220/min, duration of > 2 minutes
- History of prior diagnosis of hypertension and/or treated for hypertension OR two documented BP > 130/85 (measurements done at least one week apart)
Who cannot join
- Permanent or persistent AF or more than 6 episodes of symptomatic paroxysmal AF in the previous 6 months
- Documented Cr >200 umol/L and K+ >5.2 mmol/L in the previous 3 months
- Current treatment with a potassium sparing diuretic, unless serum potassium known to be in the normal range
- LV ejection fraction known to be < 40 %
- Moderate or severe mitral regurgitation (3+, 4 +)
- Mitral stenosis of more than mild severity
Show all 13Show fewer
- Aortic stenosis with mean gradient of > 25 mmHg
- Angina at rest in the last 2 months, or current CCS Class 3 or 4 angina
- Unipolar atrial lead
- Previous AV node ablation
- P-wave amplitude less than 1.5 mV
- Current therapy with an ACE inhibitor, ARB or aldosterone antagonist
- Current or planned (within 6 months) with an anti-arrhythmic medication (amiodarone, sotalol, flecainide, propafenone, quinidine, dofetilide
Trial locations and contacts
1 site in 1 country.
Canada1 site
Population Health Research Institute of McMaster University
Hamilton, Ontario, L8L 2X2
Ellison J. Themeles, MSc., 905-527-4322 ext. 44713, themelese@ccc.mcmaster.ca
Stuart J. Connolly, MD
About this study
Official title: Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension, Permanent Pacemakers and Risk Factors for Developing Atrial Fibrillation
The purpose of this study is to determine whether irbesartan will reduce the rate of recurrent atrial high rate episodes and the development of clinical sustained atrial fibrillation in patients with hypertension and permanent pacemaker.
Read the detailed description
Patients with permanent pacemakers have a high risk of atrial fibrillation (AF), particularly those with hypertension, sinus node dysfunction, and those with short episodes of atrial arrhythmias, known as atrial high-rate episodes (AHRE). AHRE are felt to be a precursor to AF, and may be both the result and a cause of changs in the atrial electrophysiology, and structure (known as cardiac remodeling)that are associated with the development of AF.
Evaluating this process in human AF has been limited by the cumbersome nature of performing serial, invasive electrophysiologic studies. However, modern pacemakers now permit rapid, non-invasive electrophysiologic testing and can also accurately document AHRE, which allows the convenient study of therapy aimed at preventing the progression from AHRE to overt AF. In addition, this group of patients also affords the ability to evaluate the recurrence of AHRE on the progression of structural and electrical remodeling.
Comparison: Irbesartan compared to placebo.
- Conditions
- Atrial Fibrillation, Hypertension
- Being tested
- Irbesartan
- Keywords
- Atrial Fibrillation, Arrhythmia, Pacemaker, Artificial, Atrial High Rate Episodes, Electrophysiology, Renin-Angiotensin System, Hypertension, Cardiac Remodeling
- Medical subject headings
- Atrial Fibrillation, Hypertension, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrent AHRE ( 220/min for > 2 minutes)
Secondary outcomes (9)
- Frequency of AHRE's (> 220/min for > 2 minutes) Evaluated at randomization, month 1 and 6.
- Development of sustained AF (>30 minutes), documented
by ECG, holter, rhythm strip or pacemaker electrograms
- Electrical Remodeling (AERP,SNRT,paced/sensed p-wave
duration). Evaluated at randomization, months 1 and 6.
- Markers of Inflammation (Plasma CRP,TNF-alpha, D-Dimer,
IL-6, Pro-collagen-III products, BNP,MPO,hsP). Blood collection at randomization and month 6.
- Structural Remodeling (left atrial volume, left
ventricular mass, left ventricular diastolic function. Evaluated at randomization and month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startDec 2005
- Study completionJul 2007
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Connolly, Stuart, M.D.
- Collaborators
- Sanofi, Bristol-Myers Squibb
- Investigators
- Stuart J. Connolly, MD, Principal investigator, McMaster UniversityJeffrey S Healey, MD, Principal investigator, McMaster UniversityCarlos A Morillo, MD, Principal investigator, McMaster UniversityStefan H Hohnloser, MD, Principal investigator, J.W. Goethe University, Frankfurt GermanyCarsten W Israel, MD, Principal investigator, J.W. Goethe University, Frankfurt Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225667
- Sponsor's protocol ID
- 099104
- Other IDs
- CTA-099104
- Status last verified
- Nov 2005
- First submitted
- 12 Sep 2005
- Last updated
- 23 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension, Permanent Pacemakers and Risk Factors for Developing Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00225667
- Acronym / sponsor ID
- 099104
- Conditions
- Atrial Fibrillation, Hypertension
- Keywords
- Atrial Fibrillation, Arrhythmia, Pacemaker, Artificial, Atrial High Rate Episodes, Electrophysiology, Renin-Angiotensin System, Hypertension, Cardiac Remodeling
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Connolly, Stuart, M.D.
- Collaborators
- Sanofi, Bristol-Myers Squibb
- Study start
- Dec 2005
- Study completion
- Jul 2007
- First posted
- 26 Sep 2005 (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 purpose of this study is to determine whether irbesartan will reduce the rate of recurrent atrial high rate episodes and the development of clinical sustained atrial fibrillation in patients with hypertension and permanent pacemaker.
Detailed description
Patients with permanent pacemakers have a high risk of atrial fibrillation (AF), particularly those with hypertension, sinus node dysfunction, and those with short episodes of atrial arrhythmias, known as atrial high-rate episodes (AHRE). AHRE are felt to be a precursor to AF, and may be both the result and a cause of changs in the atrial electrophysiology, and structure (known as cardiac remodeling)that are associated with the development of AF.
Evaluating this process in human AF has been limited by the cumbersome nature of performing serial, invasive electrophysiologic studies. However, modern pacemakers now permit rapid, non-invasive electrophysiologic testing and can also accurately document AHRE, which allows the convenient study of therapy aimed at preventing the progression from AHRE to overt AF. In addition, this group of patients also affords the ability to evaluate the recurrence of AHRE on the progression of structural and electrical remodeling.
Comparison: Irbesartan compared to placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sinus Node Dysfunction (with or without AV conduction disturbance)
- Permanent, atrial or dual-chamber pacemaker implanted > 2 months before enrollment and with ability to record and store atrial high-rate episodes, frequency of mode switches and to perform non-invasive electrophysiologic testing
- History of at least 6 AHRE in the last 6 months (rate > 220/min, duration of > 2 minutes
- History of prior diagnosis of hypertension and/or treated for hypertension OR two documented BP > 130/85 (measurements done at least one week apart)
Key exclusion criteria (13 listed)
- Permanent or persistent AF or more than 6 episodes of symptomatic paroxysmal AF in the previous 6 months
- Documented Cr >200 umol/L and K+ >5.2 mmol/L in the previous 3 months
- Current treatment with a potassium sparing diuretic, unless serum potassium known to be in the normal range
- LV ejection fraction known to be < 40 %
- Moderate or severe mitral regurgitation (3+, 4 +)
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 |
|---|---|---|
| Irbesartan | Drug | – |
Primary outcome
Time to recurrent AHRE ( 220/min for > 2 minutes)
9 secondary outcomes
- Frequency of AHRE's (> 220/min for > 2 minutes) Evaluated at randomization, month 1 and 6.
- Development of sustained AF (>30 minutes), documented
by ECG, holter, rhythm strip or pacemaker electrograms
- Electrical Remodeling (AERP,SNRT,paced/sensed p-wave
duration). Evaluated at randomization, months 1 and 6.
- Markers of Inflammation (Plasma CRP,TNF-alpha, D-Dimer,
IL-6, Pro-collagen-III products, BNP,MPO,hsP). Blood collection at randomization and month 6.
- Structural Remodeling (left atrial volume, left
ventricular mass, left ventricular diastolic function. Evaluated at randomization and month 6.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2005.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Stuart J. Connolly, MD principal investigator
McMaster University
Jeffrey S Healey, MD principal investigator
McMaster University
Carlos A Morillo, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irbesartan in people with Atrial Fibrillation and Hypertension, run by Connolly, Stuart, M.D. at 1 site in Canada.
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 13 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 23 Nov 2005. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Stuart J. Connolly, MD (905-527-4322 ext. 44563, connostu@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recurrent AHRE ( 220/min for > 2 minutes). 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 23 Nov 2005.