Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels

NCT03727542 | Completed FDA Device

• 1 other identifier: IU-1140
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Aortic Aneurysm; Aortic Diseases; Pacemaker DDD

Outcome Measures

Primary Outcomes (1)

• 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.

  3 weeks

Study Arms (1)

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 .

Device: adjustment of atrioventricular delay in DDD packers

Interventions

adjustment of atrioventricular delay in DDD packers DEVICE

Atrioventricular delays are going to be adjusted as 60 milisecond shorter than the patients' native PR intervals in patients with already implanted permanent pacemakers.

Short AV-delay pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Intra-ventricular conduction abnormalities (baseline QRS \>100 msec.),
• Mild to moderate aortic or mitral valve disease
• Presence of atrial fibrillation
• LV systolic dysfunction

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Istanbul, 34290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Diseases

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: November 1, 2018
• Study Start: October 15, 2018
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

TU (1)