Aortic AneurysmNCT03727542
Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels
A study testing adjustment of atrioventricular delay in DDD packers in people with Aortic Aneurysm and Aortic Diseases, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
As potential biomarkers of pressure-related aortic damage, matrix metalloproteinases (MMP) have been implicated in the pathogenesis of aortic aneurysm because of the important role they play in connective tissue homeostasis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm, Aortic Diseases, Pacemaker DDD
- What is being tested?
- adjustment of atrioventricular delay in DDD packers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2018to 15 Nov 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal LV systolic function (EF>50%),
- Healthy conduction systems
- Noncritical coronary stenoses or normal coronary arteries
- Ventricular pacing rate <10% in the last 6 months detected at the interrogation of the pacemakers
Who cannot join
- Intra-ventricular conduction abnormalities (baseline QRS >100 msec.),
- Mild to moderate aortic or mitral valve disease
- Presence of atrial fibrillation
- LV systolic dysfunction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Istanbul, 34290
About this study
Official title: Influence of Short AV Delay Pacing on Matrix Metalloproteinase Lives
As potential biomarkers of pressure-related aortic damage, matrix metalloproteinases (MMP) have been implicated in the pathogenesis of aortic aneurysm because of the important role they play in connective tissue homeostasis. In particular, a significant reduction in initially elevated serum MMP - 9 concentrations, compared with healthy controls, demonstrated after the aortic repair in patients with abdominal aortic aneurysm implies MMPs pivotal role in aortic aneurysms. Besides, due to an active degradation and repair processes taking place in the vascular wall governed by the balance between MMP enzymes and their inhibitors, MMP - 9, expression of which is predominantly associated with disruption of aortic elastic fibers, can also be detected in the serum of healthy subjects. Indeed, mechanical stress-induced upregulation of genes and their products stimulate MMP expression in the vascular wall, which is responsible for extracellular matrix degradation. Herein, it was hypothesized that reducing the acceleration rate of aortic pressure (aortic peak dP/dt) may decrease the mechanical stretch on the aortic wall which, may in turn, reduce the expression and serum levels of MMP-9.
Read the detailed description
The maximum value of acceleration rate of aortic pressure rise can be named as aortic peak dP/dt. It, likewise, corresponds to the maximum value of first derivative of aortic pressure curve with respect to time.Notably, aortic peak dP/dt would be one of the principal determinants of mechanical stress applied to the aortic wall. Hence, interventions aiming to reduce aortic peak dP/dt levels may open a new therapeutic avenue in the management of pressure-related vascular damages such as aortic aneurisms.
Since it is the principle determining factor of aortic peak dP/dt, changing LV contractility, thereby LV peak dP/dt, may be expected to lead to change aortic peak dP/dt values in the same direction. Therefore, reduction of LV dP/dt can lead to a reduction in aortic dP/dt. Previous finding strongly suggest that widening of the QRS complex could decrease LV contractility and correspondingly LV peak dP/dt value which may eventually lead to a reduction in aortic peak dP/dt.
From biomechanical point of view, as potential biomarkers of pressure-related aortic damage, matrix metalloproteinases (MMP) have been implicated in the pathogenesis of aortic aneurysm because of the important role they play in connective tissue homeostasis. In particular, a significant reduction in initially elevated serum MMP - 9 concentrations, compared with healthy controls, demonstrated after the aortic repair in patients with abdominal aortic aneurysm implies MMPs pivotal role in aortic aneurysms. Besides, due to an active degradation and repair processes taking place in the vascular wall governed by the balance between MMP enzymes and their inhibitors, MMP - 9, expression of which is predominantly associated with disruption of aortic elastic fibers, can also be detected in the serum of healthy subjects. Indeed, mechanical stress-induced upregulation of genes and their products stimulate MMP expression in the vascular wall, which is responsible for extracellular matrix degradation. Herein, we hypothesized that reducing the acceleration rate of aortic pressure (aortic peak dP/dt) may decrease the mechanical stretch on the aortic wall which, may in turn, reduce the expression and serum levels of MMP-9.
To this end, in the current trial, effect of the prolongation of QRS duration over a certain period of time by short AVD permanent pacing on the circulating levels of a vascular extracellular matrix degradation marker, MMP-9, was examined.
- Conditions
- Aortic Aneurysm, Aortic Diseases, Pacemaker DDD
- Being tested
- adjustment of atrioventricular delay in DDD packers
- Medical subject headings
- Aortic Aneurysm, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjustment of atrioventricular delay in DDD packersDevice
Atrioventricular delays are going to be adjusted as 60 milisecond shorter than the patients' native PR intervals in patients with already implanted permanent pacemakers.
| Study group | Role | What they receive |
|---|---|---|
| Short AV-delay pacing | Experimental | Participants will be their own control. Serum samples will be collected at baseline while the participants were in sinus rhythm and after 3 weeks of short AV-delay pacing serum samples will be recollected to measure matrix metalloproteinase levels . Receives: Device: adjustment of atrioventricular delay in DDD packers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MMP - 9 serum concentration from baseline to at the end of 3 weeks follow-up
MMP-9 serum concentration will be measured before and after short AV delay (wide QRS) pacing. Change in MMP-9 levels will be measured.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start15 Oct 2018
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Istanbul 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Serum level of MMP-9 will be measured initially in the blood samples collected from the patients with permanent pacemaker implantation while they were on sinus rhythm and the second samples will be collected at the end of the 3 weeks of short AVD (60 msec. shorter than patients' native PR interval) pacing to ensure wide QRS rhythm.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Murat Sezer, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727542
- Sponsor's protocol ID
- IU-1140
- Status last verified
- Dec 2018
- First submitted
- 28 Oct 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Short AV Delay Pacing on Matrix Metalloproteinase Lives
- ClinicalTrials.gov ID
- NCT03727542
- Acronym / sponsor ID
- IU-1140
- Conditions
- Aortic Aneurysm, Aortic Diseases, Pacemaker DDD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 1 Nov 2018 (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.
As potential biomarkers of pressure-related aortic damage, matrix metalloproteinases (MMP) have been implicated in the pathogenesis of aortic aneurysm because of the important role they play in connective tissue homeostasis. In particular, a significant reduction in initially elevated serum MMP - 9 concentrations, compared with healthy controls, demonstrated after the aortic repair in patients with abdominal aortic aneurysm implies MMPs pivotal role in aortic aneurysms. Besides, due to an active degradation and repair processes taking place in the vascular wall governed by the balance between MMP enzymes and their inhibitors, MMP - 9, expression of which is predominantly associated with disruption of aortic elastic fibers, can also be detected in the serum of healthy subjects. Indeed, mechanical stress-induced upregulation of genes and their products stimulate MMP expression in the vascular wall, which is responsible for extracellular matrix degradation. Herein, it was hypothesized that reducing the acceleration rate of aortic pressure (aortic peak dP/dt) may decrease the mechanical stretch on the aortic wall which, may in turn, reduce the expression and serum levels of MMP-9.
Detailed description
The maximum value of acceleration rate of aortic pressure rise can be named as aortic peak dP/dt. It, likewise, corresponds to the maximum value of first derivative of aortic pressure curve with respect to time.Notably, aortic peak dP/dt would be one of the principal determinants of mechanical stress applied to the aortic wall. Hence, interventions aiming to reduce aortic peak dP/dt levels may open a new therapeutic avenue in the management of pressure-related vascular damages such as aortic aneurisms.
Since it is the principle determining factor of aortic peak dP/dt, changing LV contractility, thereby LV peak dP/dt, may be expected to lead to change aortic peak dP/dt values in the same direction. Therefore, reduction of LV dP/dt can lead to a reduction in aortic dP/dt. Previous finding strongly suggest that widening of the QRS complex could decrease LV contractility and correspondingly LV peak dP/dt value which may eventually lead to a reduction in aortic peak dP/dt.
From biomechanical point of view, as potential biomarkers of pressure-related aortic damage, matrix metalloproteinases (MMP) have been implicated in the pathogenesis of aortic aneurysm because of the important role they play in connective tissue homeostasis. In particular, a significant reduction in initially elevated serum MMP - 9 concentrations, compared with healthy controls, demonstrated after the aortic repair in patients with abdominal aortic aneurysm implies MMPs pivotal role in aortic aneurysms. Besides, due to an active degradation and repair processes taking place in the vascular wall governed by the balance between MMP enzymes and their inhibitors, MMP - 9, expression of which is predominantly associated with disruption of aortic elastic fibers, can also be detected in the serum of healthy subjects. Indeed, mechanical stress-induced upregulation of genes and their products stimulate MMP expression in the vascular wall, which is responsible for extracellular matrix degradation. Herein, we hypothesized that reducing the acceleration rate of aortic pressure (aortic peak dP/dt) may decrease the mechanical stretch on the aortic wall which, may in turn, reduce the expression and serum levels of MMP-9.
To this end, in the current trial, effect of the prolongation of QRS duration over a certain period of time by short AVD permanent pacing on the circulating levels of a vascular extracellular matrix degradation marker, MMP-9, was examined.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Serum level of MMP-9 will be measured initially in the blood samples collected from the patients with permanent pacemaker implantation while they were on sinus rhythm and the second samples will be collected at the end of the 3 weeks of short AVD (60 msec. shorter than patients' native PR interval) pacing to ensure wide QRS rhythm.
| Arm | Type | Receives |
|---|---|---|
| Short AV-delay pacing | Experimental | Device: adjustment of atrioventricular delay in DDD packersParticipants will be their own control. Serum samples will be collected at baseline while the participants were in sinus rhythm and after 3 weeks of short AV-delay pacing serum samples will be recollected to measure matrix metalloproteinase levels . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Normal LV systolic function (EF>50%),
- Healthy conduction systems
- Noncritical coronary stenoses or normal coronary arteries
- Ventricular pacing rate <10% in the last 6 months detected at the interrogation of the pacemakers
Key exclusion criteria (4 listed)
- Intra-ventricular conduction abnormalities (baseline QRS >100 msec.),
- Mild to moderate aortic or mitral valve disease
- Presence of atrial fibrillation
- LV systolic dysfunction
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 |
|---|---|---|
| adjustment of atrioventricular delay in DDD packersAtrioventricular delays are going to be adjusted as 60 milisecond shorter than the patients' native PR intervals in patients with already implanted permanent pacemakers. | Device | Short AV-delay pacing |
Primary outcome
Change in MMP - 9 serum concentration from baseline to at the end of 3 weeks follow-up
Time frame: 3 weeks
MMP-9 serum concentration will be measured before and after short AV delay (wide QRS) pacing. Change in MMP-9 levels will be measured.
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 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adjustment of atrioventricular delay in DDD packers in people with Aortic Aneurysm and Aortic Diseases, run by Istanbul University at 1 site in Turkey (Türkiye).
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 4 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 2018. 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 Turkey (Türkiye). 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?
Change in MMP - 9 serum concentration from baseline to at the end of 3 weeks follow-up (time frame: 3 weeks). 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 2018.