Myocardial FunctionNCT01112176
Effect of Heart Rate on Left Ventricular Performance
A study testing Increase in paced heart rate in people with Myocardial Function and Myocardial Strain, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The current study is aimed at determining the normal response to increasing heart rates. For this purpose, atrial pacing will be used to increase heart rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Function, Myocardial Strain
- What is being tested?
- Increase in paced heart rate
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Apr 2012
- 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
- Patients with AAI or DDD pacemaker with intact AV nodal conduction that can be set to work in AAI mode.
- Stable rhythm (either sinus or paced).
- Good quality baseline echo.
- Able and willing to sign Informed Consent Form.
Who cannot join
- Prior heart failure or ischemic heart disease.
- Severe valvular lesions.
- Severe pulmonary hypertension.
- Known intolerance to rapid pacing.
- Multiple extrasystoles (more than 1 per echo or monitor screen).
- Age over 70.
Trial locations and contacts
1 site in 1 country.
David S. Blondheim, MD contact
Israel1 site, 1 recruiting
- Recruiting
Hille Yaffe Medical Ceter
Hadera, Israel, 38100
David Blondheim, MD, 97246304488, davidb@hy.health.gov.il
David S. Blondheim, MD
About this study
The current study is aimed at determining the normal response to increasing heart rates. For this purpose, atrial pacing will be used to increase heart rate.
Read the detailed description
Participants will be patients with pacemakers and normal A-V node conduction with a possibility for right atrial pacing mode.
Detailed Echo studies will be performed at baseline. Echo studies will be repeated at each pacing stage, stages defined as 10 bpm increments in paced heart rate. Each stage will last 2-3 min or as long as it takes to record the echo study. Heart rate will be increased to 85% of predicted heart rate for age or at to appearance of signs of ischemia.
Hemodynamic parameters will be recorded and segmental longitudinal strain will be calculated (as well as other Echo data), for each stage.
- Conditions
- Myocardial Function, Myocardial Strain
- Being tested
- Increase in paced heart rate
- Keywords
- Strain, Ejection fraction, Diastolic function
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase in paced heart rateProcedure or surgery
The pacing rate will be increased by 10 bps at every stage
What is being measured
The primary outcome is the main question the study is designed to answer.
Segmental Strain
Segmental Strain by speckle tracking method will be calculated for every stage of each study.
Measured: approx. 20 minutes
Secondary outcomes (1)
LV function
Parameters of systolic and diastolic function will be calculated at each stage.
Measured: Approx. 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial FunctionStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Investigators
- David S. Blondheim, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112176
- Sponsor's protocol ID
- 013-10-HYMC-CTIL
- Status last verified
- Apr 2010
- First submitted
- 13 Apr 2010
- Last updated
- 28 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heart Rate on Left Ventricular Performance
- ClinicalTrials.gov ID
- NCT01112176
- Acronym / sponsor ID
- 013-10-HYMC-CTIL
- Conditions
- Myocardial Function, Myocardial Strain
- Keywords
- Strain, Ejection fraction, Diastolic function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 28 Apr 2010 (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 current study is aimed at determining the normal response to increasing heart rates. For this purpose, atrial pacing will be used to increase heart rate.
Detailed description
Participants will be patients with pacemakers and normal A-V node conduction with a possibility for right atrial pacing mode.
Detailed Echo studies will be performed at baseline. Echo studies will be repeated at each pacing stage, stages defined as 10 bpm increments in paced heart rate. Each stage will last 2-3 min or as long as it takes to record the echo study. Heart rate will be increased to 85% of predicted heart rate for age or at to appearance of signs of ischemia.
Hemodynamic parameters will be recorded and segmental longitudinal strain will be calculated (as well as other Echo data), for each stage.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with AAI or DDD pacemaker with intact AV nodal conduction that can be set to work in AAI mode.
- Stable rhythm (either sinus or paced).
- Good quality baseline echo.
- Able and willing to sign Informed Consent Form.
Key exclusion criteria (6 listed)
- Prior heart failure or ischemic heart disease.
- Severe valvular lesions.
- Severe pulmonary hypertension.
- Known intolerance to rapid pacing.
- Multiple extrasystoles (more than 1 per echo or monitor screen).
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 |
|---|---|---|
| Increase in paced heart rateThe pacing rate will be increased by 10 bps at every stage | Procedure or surgery | – |
Primary outcome
Segmental Strain
Time frame: approx. 20 minutes
Segmental Strain by speckle tracking method will be calculated for every stage of each study.
1 secondary outcome
LV function
Time frame: Approx. 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
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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.
David S. Blondheim, MD contact
David S. Blondheim, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increase in paced heart rate in people with Myocardial Function and Myocardial Strain, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 28 Apr 2010. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David S. Blondheim, MD (97246304488, davidb@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Segmental Strain (time frame: approx. 20 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 28 Apr 2010.