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Effect of Pacing on Aortic dP/dt Values

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ClinicalTrials.gov Identifier: NCT03665558
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Murat Sezer, Istanbul University

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE September 11, 2018
Last Update Posted Date October 30, 2018
Actual Study Start Date  ICMJE September 3, 2018
Actual Primary Completion Date October 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2018)
Changing in aortic dP/dt in response to DDD pacing [ Time Frame: At the end of the stepwise pacing procedure completed ]
Changing in aortic dP/dt in response to DDD pacing will be determined
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03665558 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Pacing on Aortic dP/dt Values
Official Title  ICMJE Effect of DDD Pacing Titrated by Stepwise Changing of AVD on Aortic dP/dt
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Aortic Diseases
Intervention  ICMJE Device: Temporary DDD pacing
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.
Study Arms  ICMJE
  • No Intervention: Aortic dP/dt in sinus rhythm
    Left ventricular and aortic dP/dt values were recorded at baseline condition while patients are on sinus rhythm.
  • Active Comparator: Aortic dP/dt during DDD pacing
    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: Device: Temporary DDD pacing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2018)
34
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2018)
30
Actual Study Completion Date  ICMJE October 15, 2018
Actual Primary Completion Date October 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03665558
Other Study ID Numbers  ICMJE 843-1075
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dr. Murat Sezer, Istanbul University
Study Sponsor  ICMJE Istanbul University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Istanbul University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP