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Effect of Pacing on Aortic dP/dt Values

Primary Purpose

Aortic Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Temporary DDD pacing
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Diseases focused on measuring Ventricular contractility, Pacing, Ventricular dP/dt, Aortic dP/dt

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Normal left ventricular systolic function

Exclusion Criteria:

  • Abnormal left ventricular systolic function with ejection fraction < 50%
  • Presence of severe coronary artery disease
  • Presence of valvular heart disease

Sites / Locations

  • Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Aortic dP/dt in sinus rhythm

Aortic dP/dt during DDD pacing

Arm Description

Left ventricular and aortic dP/dt values were recorded at baseline condition while patients are on sinus rhythm.

Patients will be their own control. Aortic and ventricular pressures will be recorded under temporary DDD pacing again and these data collected at every pacing steps will be compared to the pressures recorded at baseline condition.

Outcomes

Primary Outcome Measures

Changing in aortic dP/dt in response to DDD pacing
Changing in aortic dP/dt in response to DDD pacing will be determined

Secondary Outcome Measures

Full Information

First Posted
September 5, 2018
Last Updated
October 28, 2018
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT03665558
Brief Title
Effect of Pacing on Aortic dP/dt Values
Official Title
Effect of DDD Pacing Titrated by Stepwise Changing of AVD on Aortic dP/dt
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
October 15, 2018 (Actual)
Study Completion Date
October 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The maximum value of rate of left ventricular pressure increase, denoted by left ventricular peak dP/dt value (dP/dt max), corresponds to the highest point on the curve of first derivative of ventricular pressure curve with respect to time. It is one of the important systolic performance parameters, which is primarily determined by ventricular contractility, and emerges in isovolumetric contraction phase when aortic valves are closed. Thus it is not influenced by parameters beyond ventricle such as aortic valve area, aortic elastance and peripheral resistance. Despite these unique advantageous, the main reason for its limited usage in assessing ventricular systolic performance instead of commonly used ejection fraction is the difficulties in its calculation, which requires incessant intraventricular pressure recordings. The maximum value of acceleration rate of aortic pressure increase can be named as aortic peak dP/dt. It, likewise, corresponds to the maximum value of first derivative of pressure curve with respect to time. Since it is one of the principal determining factors of aortic peak dP/dt, changing left ventricular contractility thereby left ventricular peak dP/dt value is expected to change aortic peak dP/dt in the same direction since all other variables being unchanged. Yet to conclude the extent of this association and magnitude of change, measuring these parameters for various contractility levels is necessary. In addition, impact of decreasing left ventricular peak dP/dt by gradually lowering ventricular contractility upon aortic peak dP/dt has not been investigated in previous studies. In the present study, changes in left ventricular and aortic peak dP/dt values in response to gradual reduction in LV contractility with stepwise changing (decremental shortening) atrio-ventricular delay (AVD) by dual chamber pacing will be investigated in patients without systolic dysfunction.
Detailed Description
The maximum value of rate of left ventricular pressure increase, denoted by left ventricular peak dP/dt value (dP/dt max), corresponds to the highest point on the curve of first derivative of ventricular pressure curve with respect to time. It is one of the important systolic performance parameters, which is primarily determined by ventricular contractility, and emerges in isovolumetric contraction phase when aortic valves are closed. Thus it is not influenced by parameters beyond ventricle such as aortic valve area, aortic elastance and peripheral resistance. Despite these unique advantageous, the main reason for its limited usage in assessing ventricular systolic performance instead of commonly used ejection fraction is the difficulties in its calculation, which requires incessant intraventricular pressure recordings. The maximum value of acceleration rate of aortic pressure increase can be named as aortic peak dP/dt. It, likewise, corresponds to the maximum value of first derivative of pressure curve with respect to time. Unlike left ventricular peak dP/dt, it emerges after aortic valve opens in early systolic ejection phase and thus is influenced by parameters beyond ventricle in addition to left ventricular contractility such as aortic elastance and compliance, vascular resistance, interference of forward and backward propagating pressure waves, stroke volume and its ejection rate (dV/dt). Notably, aortic peak dP/dt can be expected to be one of principal determinants in pressure-related damages in the vascular system. In structures exposed to variable pressures, the extent of damage depends on the magnitude and rate of acceleration of applied pressure in addition to susceptibility of the structures. Whether this mechanism, which has numerous implications from the real world, operates in the organism as well can be exemplified by the pulse pressure, which is an independent risk factor for adverse cardiovascular events apart from systolic and diastolic blood pressure levels. A wide pulse pressure suggests an accelerated rate of pressure increase. Therefore applications lowering left ventricular and aortic peak dP/dt values may open a new therapeutic avenue in management of pressure-related vascular damages such as aortic aneurisms. However, aortic peak dP/dt concept is seldom found a place even in research articles. Since it is one of the principal determining factors of aortic peak dP/dt, changing left ventricular contractility thereby left ventricular peak dP/dt value is expected to change aortic peak dP/dt in the same direction since all other variables being unchanged. Yet to conclude the extent of this association and magnitude of change, measuring these parameters for various contractility levels is necessary. In this context, it has been demonstrated that narrowing of the QRS complex by cardiac resynchronization therapy (CRT) was shown to increase left ventricular peak dP/dt value. This finding strongly suggests that widening of the QRS complex, on the contrary, will decrease left ventricular peak dP/dt value. However, impact of decreasing left ventricular peak dP/dt by gradually lowering ventricular contractility upon aortic peak dP/dt has not been investigated in previous studies. In the present study, changes in left ventricular and aortic peak dP/dt values in response to gradual reduction in left ventricular (LV) contractility with stepwise changing (decremental shortening) atrio-ventricular delay (AVD) by dual chamber pacing will be investigated in patients without LV systolic dysfunction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Diseases
Keywords
Ventricular contractility, Pacing, Ventricular dP/dt, Aortic dP/dt

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aortic dP/dt in sinus rhythm
Arm Type
No Intervention
Arm Description
Left ventricular and aortic dP/dt values were recorded at baseline condition while patients are on sinus rhythm.
Arm Title
Aortic dP/dt during DDD pacing
Arm Type
Active Comparator
Arm Description
Patients will be their own control. Aortic and ventricular pressures will be recorded under temporary DDD pacing again and these data collected at every pacing steps will be compared to the pressures recorded at baseline condition.
Intervention Type
Device
Intervention Name(s)
Temporary DDD pacing
Intervention Description
Measurements will be performed in patients otherwise undergoing invasive catheterization procedure. Baseline ventricular and aortic hemodynamic parameters (continuous pressure recordings) will be recorded. Thereafter, DDD pacing with stepwise changing of the AV delay will be performed. During each pacing steps left ventricular and aortic pressures at different aortic levels will be continuously recorded. From these hemodynamic data, left ventricular and aortic dP/dt values will be calculated off line.
Primary Outcome Measure Information:
Title
Changing in aortic dP/dt in response to DDD pacing
Description
Changing in aortic dP/dt in response to DDD pacing will be determined
Time Frame
At the end of the stepwise pacing procedure completed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Normal left ventricular systolic function Exclusion Criteria: Abnormal left ventricular systolic function with ejection fraction < 50% Presence of severe coronary artery disease Presence of valvular heart disease
Facility Information:
Facility Name
Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
City
Istanbul
ZIP/Postal Code
34290
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32390533
Citation
Sezer M, Atici A, Coskun I, Cizgici Y, Ozcan A, Umman B, Bugra Z, Ozcan I, Hasdemir H, Kocaaga M, Davies JE, Umman S. Reducing Aortic Barotrauma and Vascular Extracellular Matrix Degradation by Pacemaker-Mediated QRS Widening. J Am Heart Assoc. 2020 May 18;9(10):e014804. doi: 10.1161/JAHA.119.014804. Epub 2020 May 11.
Results Reference
derived

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Effect of Pacing on Aortic dP/dt Values

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