search
Back to results

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

Primary Purpose

Vasovagal Syncope

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pacing
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasovagal Syncope focused on measuring pacemaker, stroke volume, cardiac output, heart rate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stroke volume and cardiac output

Arm Description

Pacing runs will occur at the following rates: 50 beats per minute (bpm) 60 bpm 70 bpm 80 bpm 90 bpm 100 bpm 110 bpm 120 bpm 130 bpm The finger blood pressure cuff will be calibrated between pacing runs. Following the final pacing run while supine, the patient will be given 10 minutes to rest prior to the upright portion of the study. They will then be strapped into the table (so they will not fall) and then they will be tilted up to >70 degrees (almost standing up). They will stand for ~10 minutes prior to commencing the next pacing trains.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 31, 2018
Last Updated
May 8, 2023
Sponsor
University of Calgary
search

1. Study Identification

Unique Protocol Identification Number
NCT03446326
Brief Title
Assessment of Stroke Volume and Cardiac Output in Response to Varying Heart Rates
Acronym
Pacing_SV
Official Title
Assessment of Stroke Volume and Cardiac Output in Response to Varying Heart Rates and Body Position - a Pacemaker Based Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasovagal Syncope
Keywords
pacemaker, stroke volume, cardiac output, heart rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stroke volume and cardiac output
Arm Type
Experimental
Arm Description
Pacing runs will occur at the following rates: 50 beats per minute (bpm) 60 bpm 70 bpm 80 bpm 90 bpm 100 bpm 110 bpm 120 bpm 130 bpm The finger blood pressure cuff will be calibrated between pacing runs. Following the final pacing run while supine, the patient will be given 10 minutes to rest prior to the upright portion of the study. They will then be strapped into the table (so they will not fall) and then they will be tilted up to >70 degrees (almost standing up). They will stand for ~10 minutes prior to commencing the next pacing trains.
Intervention Type
Device
Intervention Name(s)
Pacing
Intervention Description
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 Outcome Measure Information:
Title
Change in cardiac output while atrial pacing at lower and higher rates while supine
Description
Change in cardiac output (CO) when atrial pacing at 80 bpm & 120 bpm while supine. CO = HR x Stroke volume (SV)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Change in cardiac output at lower and higher ventricular (VVI) paced rates while supine
Description
Change in Cardiac output at ventricular (VVI) paced rates when it is lower (50-70 bpm) and higher (130 bpm) while supine
Time Frame
1 day
Title
Change of cardiac output at lower and higher atrial (AAI) paced rates while supine versus while upright
Description
Change of cardiac output at lower and higher atrial (AAI) paced rates while supine versus while upright at different paced rates
Time Frame
1 day
Title
Change of cardiac output at lower and higher ventricular (VVI) paced rates while supine versus while upright
Description
Change of cardiac output at lower and higher ventricular (VVI) paced rates while supine versus while upright at different paced rates
Time Frame
1 day
Title
Change in stroke volume at lower and higher atrial paced rates while tilted up
Description
Change in stroke volume at lower (50-70 bpm) vs. higher (130 bpm) atrial paced rates while tilted up
Time Frame
1 day
Title
Change in stroke volume at lower and higher ventricular (VVI) paced rates while tilted up
Description
Change in stroke volume at ventricular (VVI) paced rates when it is lower (50-70 bpm) and higher (130 bpm) while tilted up
Time Frame
1 day
Title
Change of stroke volume at lower and higher atrial (AAI) paced rates while supine versus while upright
Description
Change of stroke volume at lower and higher atrial (AAI) paced rates while supine versus while upright at different paced rates
Time Frame
1 day
Title
Change of stroke volume at lower and higher ventricular (VVI) paced rates while supine versus while upright
Description
Change of stroke volume at lower and higher ventricular (VVI) paced rates while supine versus while upright at different paced rates
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Satish R Raj, MD MSCI
Phone
4032106152
Email
satish.raj@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish R Raj, MD MSCI
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satish R Raj, MD, MSCI
Phone
403-210-6152
Email
autonomic.research@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Robert S Sheldon, MD, PhD
Phone
403-220-8191
Email
autonomic.research@ucalgary.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs