Assessing Systemic Circulation and LV Performance in Adults

NCT04347655 | Recruiting

• 1 other identifier: REB20-0465
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Head-Capacity Curve (HCC)

  systolic arterial blood pressure (SBP) when CI = 4 L/min/m2

  1 day

Secondary Outcomes (2)

• Cardiac Power

  1 day

• Systemic Vascular Conductance (SVC)

  1 day

Study Arms (3)

HFrEF

EXPERIMENTAL

patients with heart failure with reduced ejection fraction

Procedure: handgrip test

HFpEF

EXPERIMENTAL

heart failure with preserved ejection fraction

Procedure: handgrip test

Control

ACTIVE COMPARATOR

healthy (no heart failure) control participants

Procedure: handgrip test

Interventions

handgrip test PROCEDURE

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.

Control; HFpEF; HFrEF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Satish R Raj, MD MSCI

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rasha Hamzeh, RN

CONTACT

4032208897; autonomic.research@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiac Sciences

Model Details: Heart Failure Patients (with reduced and preserved ejection fraction) and Healthy Control Subjects will be studied with the same protocol

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 15, 2020
• Study Start: September 15, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)