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Assessment of Stroke Volume and Cardiac Output in Response to Varying Heart Rates

Assessment of Stroke Volume and Cardiac Output in Response to Varying Heart Rates and Body Position - a Pacemaker Based Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03446326
Acronym
Pacing_SV
Enrollment
25
Registered
2018-02-26
Start date
2018-01-01
Completion date
2028-01-01
Last updated
2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasovagal Syncope

Keywords

pacemaker, stroke volume, cardiac output, heart rate

Brief summary

The investigators will seek to determine the effects of different heart rates on both stroke volume and cardiac output using non-invasive hemodynamic assessments. In order to safely manipulate the HR, the investigators will study patients with permanent pacemakers in whom heart rate manipulation can be done in a safe and non-invasive manner.

Detailed description

Permanent pacemakers have sometimes been used to treat patients with recurrent vasovagal syncope. This is because patients with vasovagal syncope often experience bradycardia at the time of their syncope. Unfortunately, pacemakers are often ineffective in preventing syncope. Classical cardiovascular hemodynamics would suggest that increasing the heart rate (HR; via pacemaker) should increase the cardiac output (CO). This is because: CO = HR x Stroke volume (SV). The assumption is that the SV is fixed during manipulation of the HR. However, this might not be the case. As the number of beats per minute (HR) increases, the cardiac cycle length (R-R interval \[RRI\]) shortens, as a function of simple math. This means that the time in cardiac systole shortens, and the time in cardiac diastole shortens. Since cardiac diastole is when the heart fills up with blood, faster HR can be associated with decreased cardiac filling times. This, in turn, could compromise the SV. However, there is a paucity of data as to what happens to SV and CO at different HR. Further, it is possible that these effects will be different when a person is lying down supine versus when a patient is upright (when stroke volume will be lower). The investigators will seek to determine the effects of different HR on both SV & CO. In order to safely manipulate the HR, they will study patients with permanent pacemakers in whom HR manipulation can be done in a safe and non-invasive manner.

Interventions

DEVICEPacing

Assess the non-invasively determined stroke volume and cardiac output response at different paced heart rates in patients with a cardiac pacemaker or implanted defibrillator with preserved ejection fractions (LVEF≥50%)

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-70 years (inclusive) * Implanted permanent pacemaker or implanted defibrillator capable of atrial and ventricular pacing * LV ejection fraction \>50%

Exclusion criteria

* Unable or unwilling to provide informed consent * Clinical need for a cardiac resynchronization device

Design outcomes

Primary

MeasureTime frameDescription
Change in cardiac output while atrial pacing at lower and higher rates while supine1 dayChange in cardiac output (CO) when atrial pacing at 80 bpm & 120 bpm while supine. CO = HR x Stroke volume (SV)

Secondary

MeasureTime frameDescription
Change of cardiac output at lower and higher atrial (AAI) paced rates while supine versus while upright1 dayChange of cardiac output at lower and higher atrial (AAI) paced rates while supine versus while upright at different paced rates
Change of cardiac output at lower and higher ventricular (VVI) paced rates while supine versus while upright1 dayChange of cardiac output at lower and higher ventricular (VVI) paced rates while supine versus while upright at different paced rates
Change in stroke volume at lower and higher atrial paced rates while tilted up1 dayChange in stroke volume at lower (50-70 bpm) vs. higher (130 bpm) atrial paced rates while tilted up
Change in cardiac output at lower and higher ventricular (VVI) paced rates while supine1 dayChange in Cardiac output at ventricular (VVI) paced rates when it is lower (50-70 bpm) and higher (130 bpm) while supine
Change of stroke volume at lower and higher atrial (AAI) paced rates while supine versus while upright1 dayChange of stroke volume at lower and higher atrial (AAI) paced rates while supine versus while upright at different paced rates
Change of stroke volume at lower and higher ventricular (VVI) paced rates while supine versus while upright1 dayChange of stroke volume at lower and higher ventricular (VVI) paced rates while supine versus while upright at different paced rates
Change in stroke volume at lower and higher ventricular (VVI) paced rates while tilted up1 dayChange in stroke volume at ventricular (VVI) paced rates when it is lower (50-70 bpm) and higher (130 bpm) while tilted up

Countries

Canada

Contacts

Primary ContactSatish R Raj, MD MSCI
satish.raj@ucalgary.ca4032106152

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026