Heart FailureNCT04347655
Assessing Systemic Circulation and LV Performance in Adults
A study testing handgrip test in people with Heart Failure, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- handgrip test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2021to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable or unwilling to provide informed consent
- On intravenous inotrope or pressor medications to maintain their cardiac function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 4Z6
Satish R Raj, MD MSCI, 403-210-6152, autonomic.research@ucalgary.ca
Robert S Sheldon, MD PhD, 403-220-8191, autonomic.research@ucalgary.ca
About this study
Official title: A Novel Approach to the Assessment of the Systemic Circulation and Left Ventricular Performance in Adults
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.
Read more
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- handgrip test
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handgrip testProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| HFrEF | Experimental | patients with heart failure with reduced ejection fraction Receives: Procedure: handgrip test |
| HFpEF | Experimental | heart failure with preserved ejection fraction Receives: Procedure: handgrip test |
| Control | Active comparator | healthy (no heart failure) control participants Receives: Procedure: handgrip test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head-Capacity Curve (HCC)
systolic arterial blood pressure (SBP) when CI = 4 L/min/m2
Measured: 1 day
Secondary outcomes (2)
Cardiac Power
cardiac power (SBP * CI) when CI = 4 L/min/m2
Measured: 1 day
Systemic Vascular Conductance (SVC)
SVC is the slope of the regression line (going through the origin) between SBP and CI
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start15 Sep 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Satish Raj, University of Calgary
- Investigators
- Satish R Raj, MD MSCI, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347655
- Sponsor's protocol ID
- REB20-0465
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2020
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to the Assessment of the Systemic Circulation and Left Ventricular Performance in Adults
- ClinicalTrials.gov ID
- NCT04347655
- Acronym / sponsor ID
- REB20-0465
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Heart Failure Patients (with reduced and preserved ejection fraction) and Healthy Control Subjects will be studied with the same protocol
| Arm | Type | Receives |
|---|---|---|
| HFrEF | Experimental | Procedure: handgrip testpatients with heart failure with reduced ejection fraction |
| HFpEF | Experimental | Procedure: handgrip testheart failure with preserved ejection fraction |
| Control | Active comparator | Procedure: handgrip testhealthy (no heart failure) control participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable or unwilling to provide informed consent
- On intravenous inotrope or pressor medications to maintain their cardiac function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| handgrip testThe 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. | Procedure or surgery | Control, HFpEF, HFrEF |
Primary outcome
Head-Capacity Curve (HCC)
Time frame: 1 day
systolic arterial blood pressure (SBP) when CI = 4 L/min/m2
2 secondary outcomes
Cardiac Power
Time frame: 1 day
Systemic Vascular Conductance (SVC)
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Satish R Raj, MD MSCI principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing handgrip test in people with Heart Failure, run by University of Calgary at 1 site in Canada.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rasha Hamzeh, RN (4032208897, autonomic.research@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head-Capacity Curve (HCC) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.