AzTrials
AzTrials

Aortic DiseasesNCT03665558

Effect of Pacing on Aortic dP/dt Values

A study testing Temporary DDD pacing in people with Aortic Diseases, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Aortic Diseases
What is being tested?
Temporary DDD pacing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Sep 2018to 15 Oct 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 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Normal left ventricular systolic function

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology

    Istanbul, 34290

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of DDD Pacing Titrated by Stepwise Changing of AVD on Aortic dP/dt

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.

Read more

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.

Read the 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.

Conditions
Aortic Diseases
Being tested
Temporary DDD pacing
Keywords
Ventricular contractility, Pacing, Ventricular dP/dt, Aortic dP/dt
Medical subject headings
Aortic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Temporary DDD pacingDevice

    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 groups in NCT03665558
Study groupRoleWhat they receive
Aortic dP/dt in sinus rhythmNo interventionLeft ventricular and aortic dP/dt values were recorded at baseline condition while patients are on sinus rhythm.
Aortic dP/dt during DDD pacingActive comparatorPatients 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.
Receives: Device: Temporary DDD pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changing in aortic dP/dt in response to DDD pacing

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

    Measured: At the end of the stepwise pacing procedure completed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2018
  2. Study start3 Sep 2018
  3. Primary completion15 Oct 2018
  4. Study completion15 Oct 2018

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03665558
Sponsor's protocol ID
843-1075
Status last verified
Sep 2018
First submitted
5 Sep 2018
Last updated
30 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32390533

Questions about this trial

What is this clinical trial studying?

A study testing Temporary DDD pacing in people with 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 1 inclusion and 3 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 30 Oct 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?

Changing in aortic dP/dt in response to DDD pacing (time frame: At the end of the stepwise pacing procedure completed). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03665558, which also lists 1 linked publication.

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 30 Oct 2018.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in