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Assessing Systemic Circulation and LV Performance in Adults

Primary Purpose

Heart Failure

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

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 years or older
  • Clinical heart failure (HFrEF or HFpEF) for heart failure patients and no clinical heart failure for the non-heart failure participants.

Exclusion Criteria:

  • Unable or unwilling to provide informed consent
  • On intravenous inotrope or pressor medications to maintain their cardiac function

Sites / Locations

  • University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

HFrEF

HFpEF

Control

Arm Description

patients with heart failure with reduced ejection fraction

heart failure with preserved ejection fraction

healthy (no heart failure) control participants

Outcomes

Primary Outcome Measures

Head-Capacity Curve (HCC)
systolic arterial blood pressure (SBP) when CI = 4 L/min/m2

Secondary Outcome Measures

Cardiac Power
cardiac power (SBP * CI) when CI = 4 L/min/m2
Systemic Vascular Conductance (SVC)
SVC is the slope of the regression line (going through the origin) between SBP and CI

Full Information

First Posted
April 12, 2020
Last Updated
January 7, 2023
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT04347655
Brief Title
Assessing Systemic Circulation and LV Performance in Adults
Official Title
A Novel Approach to the Assessment of the Systemic Circulation and Left Ventricular Performance in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background There are significant limitations in the current approaches to assessing 2 important areas of cardiovascular physiology - the systemic circulation and left ventricular (LV) performance. The investigators' have repurposed the concepts of "systemic vascular conductance" to assess systemic circulation, and the "head capacity principle" to assess LV performance. The investigators' now seek to test these concepts in human adults, with heart failure and without heart failure, using non-invasive methods. Hypothesis There will be a depressed head-capacity curve and reduced power among patients with heart failure which will indicate compromised left ventricular pump function. Methods The research study will involve a single outpatient visit per subject. The study will take place with the subject supine on a bed/table. The subjects will be instrumented with EKG electrodes and finger blood pressure cuffs. The continuous finger BP device performs a waveform analysis in real-time to determine the non-invasive stroke volume, cardiac output, and blood pressure. The patient will be supine for at least 5 minutes to collect baseline data before being handed a dynamometer device. The subject will then be asked to squeeze the dynamometer with maximum force for a minimum of 2 minutes while only engaging their forearm and remaining relaxed in the rest of their body. The subject will then release the dynamometer and remain supine, in recovery, for a minimum of 5 minutes. Following the handgrip test, the instrumentation will be removed and the patient's participation in the study will be complete. The study duration should be about 20 min.
Detailed Description
Background There are significant limitations in our current approaches to assessing 2 important areas of cardiovascular physiology - the systemic circulation and left ventricular (LV) performance. Using engineering principles, the investigators' have repurposed 2 concepts to develop novel (and hopefully improved) interpretation of integrated cardiovascular function. These concepts are "systemic vascular conductance" for systemic circulation and the "head capacity principle" for LV performance, which have been demonstrated in animal physiology experiments using a porcine model. In this protocol, the investigators' seek to test these concepts in human adults, with heart failure and without heart failure, using non-invasive methods. Aims and Hypotheses Primary Aim: To evaluate cardiovascular function in patients with heart failure using a head-capacity relation to assess left ventricular pump function as well as by assessing systemic vascular conductance. Hypothesis: There will be a depressed head-capacity curve and reduced power among patients with heart failure which will indicate compromised left ventricular pump function. In addition, heart failure patients will have decreased systemic vascular conductance. Specific Aim#1: The investigators' will compare patients with heart failure with reduced ejection fraction (HFrEF) to healthy (no heart failure) control participants. Specific Aim #2: The investigators' will compare patients with heart failure with preserved ejection fraction (HFpEF) to healthy (no heart failure) control participants. Methods The research study will take place in the TRW Building on the University of Calgary Foothills Campus. This will involve a single outpatient visit per subject. Patients can be brought to the TRW building from the Cardiac Function Clinic or Cardiac Device Clinic in a wheelchair, accompanied by a member of the research team or can arrive to the TRW building by their own means. As a part of the consent process, the subject will be asked to allow access to their clinical records for research purposes. This will include collecting information about their heart failure such as their ejection fraction, NYHA class, medications, and whether they have an implanted permanent pacemaker or implanted defibrillator capable of atrial and ventricular pacing. The study will take place with the subject supine on a bed/table. The subjects will be instrumented with EKG electrodes and finger blood pressure cuffs. The continuous finger BP device performs a waveform analysis in real-time to determine the non-invasive stroke volume, cardiac output, and blood pressure. These will be connected to a laptop for continuous digital acquisition through an analog:digital conversion card. The patient will be supine for at least 5 minutes to collect baseline data before being handed a dynamometer device. The subject will then be asked to squeeze the dynamometer with maximum force for a minimum of 2 minutes while only engaging their forearm and remaining relaxed in the rest of their body. The subject will then release the dynamometer and remain supine, in recovery, for a minimum of 5 minutes. Following the handgrip test, the instrumentation will be removed and the patient's participation in the study will be complete. The study duration should be about 20 min.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Heart Failure Patients (with reduced and preserved ejection fraction) and Healthy Control Subjects will be studied with the same protocol
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HFrEF
Arm Type
Experimental
Arm Description
patients with heart failure with reduced ejection fraction
Arm Title
HFpEF
Arm Type
Experimental
Arm Description
heart failure with preserved ejection fraction
Arm Title
Control
Arm Type
Active Comparator
Arm Description
healthy (no heart failure) control participants
Intervention Type
Procedure
Intervention Name(s)
handgrip test
Intervention Description
The patient will be supine for at least 5 minutes to collect baseline data before being handed a dynamometer device. The subject will then be asked to squeeze the dynamometer with maximum force for a minimum of 2 minutes while only engaging their forearm and remaining relaxed in the rest of their body. The subject will then release the dynamometer and remain supine, in recovery, for a minimum of 5 minutes.
Primary Outcome Measure Information:
Title
Head-Capacity Curve (HCC)
Description
systolic arterial blood pressure (SBP) when CI = 4 L/min/m2
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Cardiac Power
Description
cardiac power (SBP * CI) when CI = 4 L/min/m2
Time Frame
1 day
Title
Systemic Vascular Conductance (SVC)
Description
SVC is the slope of the regression line (going through the origin) between SBP and CI
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Clinical heart failure (HFrEF or HFpEF) for heart failure patients and no clinical heart failure for the non-heart failure participants. Exclusion Criteria: Unable or unwilling to provide informed consent On intravenous inotrope or pressor medications to maintain their cardiac function
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rasha Hamzeh, RN
Phone
4032208897
Email
autonomic.research@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

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Assessing Systemic Circulation and LV Performance in Adults

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