Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03446326

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pacing

Device

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%)

Primary outcomes

  1. Change in cardiac output while atrial pacing at lower and higher rates while supine

    Time frame: 1 day

    Change in cardiac output (CO) when atrial pacing at 80 bpm & 120 bpm while supine. CO = HR x Stroke volume (SV)

Secondary outcomes

  1. Change in cardiac output at lower and higher ventricular (VVI) paced rates while supine

    Time frame: 1 day

    Change in Cardiac output at ventricular (VVI) paced rates when it is lower (50-70 bpm) and higher (130 bpm) while supine

  2. Change of cardiac output at lower and higher atrial (AAI) paced rates while supine versus while upright

    Time frame: 1 day

    Change of cardiac output at lower and higher atrial (AAI) paced rates while supine versus while upright at different paced rates

  3. Change of cardiac output at lower and higher ventricular (VVI) paced rates while supine versus while upright

    Time frame: 1 day

    Change of cardiac output at lower and higher ventricular (VVI) paced rates while supine versus while upright at different paced rates

  4. Change in stroke volume at lower and higher atrial paced rates while tilted up

    Time frame: 1 day

    Change in stroke volume at lower (50-70 bpm) vs. higher (130 bpm) atrial paced rates while tilted up

  5. Change in stroke volume at lower and higher ventricular (VVI) paced rates while tilted up

    Time frame: 1 day

    Change in stroke volume at ventricular (VVI) paced rates when it is lower (50-70 bpm) and higher (130 bpm) while tilted up

  6. Change of stroke volume at lower and higher atrial (AAI) paced rates while supine versus while upright

    Time frame: 1 day

    Change of stroke volume at lower and higher atrial (AAI) paced rates while supine versus while upright at different paced rates

  7. Change of stroke volume at lower and higher ventricular (VVI) paced rates while supine versus while upright

    Time frame: 1 day

    Change of stroke volume at lower and higher ventricular (VVI) paced rates while supine versus while upright at different paced rates

Study contacts

Contact information is provided by the study sponsor or research team.

Satish R Raj, MD MSCI

CONTACT

[email protected]

4032106152

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Acronym: Pacing_SV

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Feb 26, 2018
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.