Prolonged QT IntervalNCT00883610
Effects Rapid Atrial Pacing Has on the Electrocardiogram (ECG) in Patients With Dual Chamber Pacemakers
An observational study of Prolonged QT Interval, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to learn what effect rapid atrial pacing (in patients with dual chamber pacemakers) will have on the electrocardiogram including the QT Interval. The investigators are also interested in the differences caused by genes. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Prolonged QT Interval
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jun 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiology Clinic
Who may be able to join
- Must be at least 21 years old
- Must have a dual chamber pacemaker implanted more than three months ago
- Must be followed by the Vanderbilt University Medical Center's Arrhythmia Device Clinic
- The indication for the pacemaker must not be related to coronary artery disease (CAD) or congestive heart failure (CHF)
Who cannot join
- Cannot be pacemaker dependent
- History of ventricular arrhythmias and/or implantable defibrillators (ICDs)
- History of paroxysmal, persistent, or permanent atrial fibrillation (AF)
- Congenital long QT syndrome
- History of coronary artery disease
- History of, or currently receiving, treatment for congestive heart failure
Show all 10Show fewer
- Unable to tolerate dual-chamber pacing (DDD) at 90 bpm due to palpitations, chest pain, shortness of breath, lightheadedness, dizziness, or presyncope
- Pregnant women
- Any patient without specific documentation of an echocardiogram negative for CHF (systolic or diastolic dysfunction)within five years prior to study enrollment
- Any patient without specific documentation of an objective diagnostic test to rule out CAD within five years prior to study enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8802
About this study
Official title: Modulation of QT Interval by Rapid Atrial Pacing in Patients With Dual Chamber Pacemakers
The purpose of this study is to learn what effect rapid atrial pacing (in patients with dual chamber pacemakers) will have on the electrocardiogram including the QT Interval. The investigators are also interested in the differences caused by genes.
Read the detailed description
This study requires a total of two study days as well as two follow up visits. During study day one, baseline blood will be drawn, a baseline electrocardiogram will be performed, and continuous QT Interval monitoring will be performed. The pacemaker rate will be increased to 90bpm at different time intervals and additional blood will be drawn to measure the effects of these rates changes.
On study day two, baseline blood will be drawn, a urine specimen will be obtained, an electrocardiogram will be performed, and continuous QT Interval monitoring will be performed. Following the acquisition of this information, the pacemaker rate will be decreased to 80bpm. We will obtain blood specimens, a urine specimen and an electrocardiogram at 30 minutes post rate change and again at 60 minutes post rate change.
Two days following the rate decrease to 80bpm, the patient will return to clinic to have their rate decreased to 70bpm. In two more days, the patient will return for a final rate change to 60bpm.
- Conditions
- Prolonged QT Interval
- Keywords
- QT Interval, Dual Chamber Pacemaker, Atrial Fibrillation
- Medical subject headings
- Long QT Syndrome, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of abrupt changes in atrial rate on QT intervals
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged QT IntervalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Dawood Darbar, Vanderbilt University
- Investigators
- Dawood Darbar, M.D., Ph.D., F.A.C.C., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883610
- Sponsor's protocol ID
- 070070
- Status last verified
- Dec 2014
- First submitted
- 16 Apr 2009
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of QT Interval by Rapid Atrial Pacing in Patients With Dual Chamber Pacemakers
- ClinicalTrials.gov ID
- NCT00883610
- Acronym / sponsor ID
- 070070
- Conditions
- Prolonged QT Interval
- Keywords
- QT Interval, Dual Chamber Pacemaker, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Wake Forest University Health Sciences
- Study start
- Apr 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Apr 2009 (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 learn what effect rapid atrial pacing (in patients with dual chamber pacemakers) will have on the electrocardiogram including the QT Interval. The investigators are also interested in the differences caused by genes.
Detailed description
This study requires a total of two study days as well as two follow up visits. During study day one, baseline blood will be drawn, a baseline electrocardiogram will be performed, and continuous QT Interval monitoring will be performed. The pacemaker rate will be increased to 90bpm at different time intervals and additional blood will be drawn to measure the effects of these rates changes.
On study day two, baseline blood will be drawn, a urine specimen will be obtained, an electrocardiogram will be performed, and continuous QT Interval monitoring will be performed. Following the acquisition of this information, the pacemaker rate will be decreased to 80bpm. We will obtain blood specimens, a urine specimen and an electrocardiogram at 30 minutes post rate change and again at 60 minutes post rate change.
Two days following the rate decrease to 80bpm, the patient will return to clinic to have their rate decreased to 70bpm. In two more days, the patient will return for a final rate change to 60bpm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology Clinic
Key inclusion criteria (4 listed)
- Must be at least 21 years old
- Must have a dual chamber pacemaker implanted more than three months ago
- Must be followed by the Vanderbilt University Medical Center's Arrhythmia Device Clinic
- The indication for the pacemaker must not be related to coronary artery disease (CAD) or congestive heart failure (CHF)
Key exclusion criteria (10 listed)
- Cannot be pacemaker dependent
- History of ventricular arrhythmias and/or implantable defibrillators (ICDs)
- History of paroxysmal, persistent, or permanent atrial fibrillation (AF)
- Congenital long QT syndrome
- History of coronary artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the effect of abrupt changes in atrial rate on QT intervals
Time frame: 7 days
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 11 Dec 2014.
Related trials for Prolonged QT Interval
RecruitingObservational study
Wearable Devices for Patient Monitoring in Long QT Syndrome
Long QT Syndrome
RecruitingObservational study
Psychotropic-Drug-induced QT Prolongation and ECG Monitoring in the Pediatric Population
Eating Disorders, Mood Disorders in Children and Adolescents
RecruitingObservational study
Do QT-Prolonging Drugs Cause Major Adverse Cardiac Events in Hospitalized Adults?
Acquired Long QT, Ventricular Arrhythmias
RecruitingPhase 4
Effect of Methadone and Hydromorphone on the QT Interval After Anesthesia and Surgery
EKG-QT Prolongation
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.
Dawood Darbar, M.D., Ph.D., F.A.C.C. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolonged QT Interval, run by Vanderbilt 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 4 inclusion and 10 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 11 Dec 2014. 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.
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?
Determine the effect of abrupt changes in atrial rate on QT intervals (time frame: 7 days). 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 11 Dec 2014.