Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT04347655

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

handgrip test

Study Details

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.

Conditions

Heart Failure

Study ID

NCT04347655

Start date

Sep 15, 2021

Status verified date

Apr, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: HFrEF

patients with heart failure with reduced ejection fraction

experimental: HFpEF

heart failure with preserved ejection fraction

active comparator: Control

healthy (no heart failure) control participants

Interventions

handgrip test

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

  • Head-Capacity Curve (HCC) [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

More Information

Sponsor

University of Calgary

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-05-05.